General Surgery News - Extended Wound Care Coverage

GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

EXTENDED EXTENDED WOUND WOUND CARE CARE COVERAGE COVERAGE March 2021

Column Editors Jarrod P. Kaufman, MD, FACS, and Peter Kim, MD

Experts Highlight Emerging Biophysical Approaches to Advanced Wound Care

By JENNA BASSETT, PhD

T

Data Grow for Negative Pressure Wound Therapy With Instillation, Dwell Time

By VICTORIA STERN

I

n early 2020, a 54-year-old man arrived at the Arizona Burn Center, in Phoenix, with a thirddegree burn stretching from his knee to the midthigh. The patient had spilled scalding-hot food down his right leg while cooking dinner.

Marc Matthews, MD, got to work immediately.

After surgically debriding the wound to the muscle and fascia, he began a process known as negative pressure wound therapy (NPWT) with instillation and dwell time to continuously clean and promote wound healing (V.A.C. VERAFLO Therapy, KCI).

A standard of care for treating wounds, NPWT acts as a vacuum, suctioning excess fluids and debris continued on page 18

he field of wound care is evolving rapidly as novel technologies are steadily being developed.

In a session at the virtual 2020 Symposium on Advanced Wound Care fall meeting, Hollie Mangrum, PT, DPT, CWS, and Renee Cordrey, PT, PhD(c), MSPT, MPH, CWS, reviewed six new and emerging biophysical approaches.

Wounds that heal improperly, incompletely or too slowly may lead to chronic wounds and morbidity that can impose a significant burden on the patient and provider. It comes as no surprise, then, that clinicians and researchers have developed advanced wound care technologies to support safe and optimized healing.

Extracorporeal shock wave therapy is an emerging technology that uses sound waves to promote wound healing and decrease pain.

MONEY MATTERS

Looking for Rewarding Work That Pays?

Consider Wound Care

By MONICA J. SMITH

Images: Adobe Stock

G

eneral surgeons looking for ways to offset pandemic-related revenue loss might consider exploring wound care management. They may already have some of the skills, the need is high, and the reimbursement is there.

“If you’re doing wound care, you’re going to be very busy and you’re going to be compensated,” said Harold Brem, MD, the chief of the Division of Wound Healing & Regenerative Medicine at Newark Beth Israel Medical Center, in New Jersey. “You’ll probably see more hospital patients and be capitated at a higher rate than if you were doing gallbladder operations, and you’ll be providing an equally if not greater service by meeting an unmet patient need.”

This demand is especially high now because many patients delayed care last year out of fear of exposure to COVID-19 in medical settings. “They got precipitously worse,” Dr. Brem said. “These patients

usually don’t have the advantages of being treated by a skilled surgeon, but when you apply the best surgical skills, the healing rates are terrific. And it’s extremely rewarding. For many surgeons, this work may turn out to be the most satisfying surgery they do.”

Who Owns Wound Care Management?

Currently, more than 7 million people in the United States live with chronic wounds. Despite this number, no doctors are formally trained in wound care. Once predominantly the domain of nurses, wound care management doesn’t belong to any specific specialty, although some may be a more natural fit than others. The four specialties that include wound care as part of their primary board certification are plastic surgery, general surgery, vascular surgery and dermatology.

“In the last 20 years, we’ve seen a rise in wound care centers driven by reimbursement for hyperbaric

continued on page 22

“Physical therapists started using energy modalities, such as electrical stimulation and ultraviolet light, several decades ago,” explained Dr. Cordrey. These technologies support recovery by stimulating a patient’s natural woundhealing processes. Electrical stimulation sends electrical pulses through electrodes attached to the wound site, which increases capillary density and perfusion to support oxygenation. Because cells have an electrical charge, the polarity of the electrode can draw oppositely charged cells, through which electrical stimulation also promotes continued on page 24

Wound Care: The ‘Wild Wild West’? Part 2 Page 16

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GENERAL SURGERY NEWS / MARCH 2021

Wound Care: The Wild, Wild West?

(Part 2)

I

n this issue, we feature Part 2 of Wound Care: The Wild, Wild West. (Part 1 was published in the October 2020 issue, page 13). This is a relatively new topic for our On the Spot column but a relevant one to most practices, since there is some element of wound care in every surgical specialty. Some of the questions we tackle are the following: • Is the bar too low for bringing wound products to the marketplace based on classification as devices and not drugs?

• Is it fair to say that often physicians do not know how to stage pressure injuries correctly

by National Pressure Injury Advisory Panel guidelines?

• Do topical antibiotics have a role in wound care?

• Do Dakin’s solution, vinegar and saline still have a vital role in wound care?

Read on to see what these experts think!

I would like to thank all of the contributors for their efforts and candor. Their hard work and time make this a compelling and informative second installment for all readers. Feel free to email me at colleen@cmhadvisors.com with any ideas for debate. Thanks for reading!

—Colleen Hutchinson Colleen Hutchinson is a medical communications consultant at CMH Media, based in Philadelphia. She can be reached at colleen@cmhadvisors.com.

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Topical antibiotics have a role in wound care.

DR. PARK: ON THE FENCE. A wound is a culture dish on which

you want tissue to grow and infectious microbes to die.

Topical antibiotics are not suitable for infection, but can potentially aid in decontamination without the systemic toxicity of antibiotic therapies, but are ineffective as substitutes for surgical debridement and therapies for infection—which is different from contamination.

Topical antibiotics play no significant role in wound care. Studies have failed to show a benefit of topical antibiotics in preventing infections.

A comparison of bacitracin ointment and white petrolatum revealed no significant difference in the rate of infection [JAMA 1996;276(12):972-977]. Furthermore, on rare occasions, antibiotic ointment use is associated with contact reactions or dermatitis that can hinder wound healing. It is most likely the moist wound environment provided by ointments, i.e., Vaseline or petrolatum, that promotes wound healing. What does render a big impact on wound healing is irrigation, which removes particulate matter and decreases the bacterial count. In addition, comorbidities and conditions such as diabetes, renal insufficiency, obesity, vascular disease, immunodeficiencies, malnutrition and smoking may play a bigger role in wound complications, and their presence needs to be prioritized and optimized.

DR. CORDOVA: DISAGREE.

This is because I am concerned that the routine use of topical antibiotics in chronic wound care might be setting the stage unnecessarily for antibiotic resistance. There are many effective topical non-antibiotic antimicrobials available to use instead.

Since a chronic wound’s bioburden [bacterial load] is usually protected in a biofilm environment, the use of a topical antibiotic might have an overall decrease in its effectiveness while at the same time increasing its risk for the development of resistance.

DR. CAVALIERE: AGREE. Physicians and other health care pro-

viders receive limited wound care education and training. Pressure injury staging is not difficult; however, if not used on a regular basis, the stages are easy to forget.

Correct documentation of pressure injury presence and stage upon admission are necessary to allow hospitals to report and track patient safety and quality. A pressure injury that is not documented within 24 hours of admission may be considered hospital-acquired and the hospital will not be reimbursed for the cost of caring for the pressure injury.

In many hospitals, evaluation and treatment of pressure injuries is considered a nursing responsibility with limited physician involvement. Pressure injuries typically develop in patients suffering from severe illness and patients with multiple comorbidities. Physician involvement in wound evaluation and management is essential to ensure the extent of the wound is considered in the context of the patient’s overall health. Discussion with patients and family members regarding overall condition and prognosis should include a review of the status of the wound.

DR. WOLLHEIM: DISAGREE, since I would not characterize the frequency of incorrectly staging a pressure injury as “often.” There are many health care clinicians who stage correctly. However, I do agree with the concept that if a pressure injury is incorrectly staged, this could have negative regulatory and/or legal implications.

DR. WOLLHEIM: DISAGREE.

EXPERT PANELISTS Christi Cavaliere, MD Department of Plastic Surgery, Cleveland Clinic, Cleveland

Alfredo C. Cordova, MD, FACS The Ohio State University Wexner Medical Center, Department of Surgery, Division of Critical Care, Trauma, and Burn Cleveland

Woosup Michael Park, MD Chief, Vascular Surgery Cleveland Clinic Abu Dhabi Al Maryah Island, Abu Dhabi

Don Wollheim, MD, FACS General Surgeon and Managing Partner at Implexus Wound Care Service Certified in wound care and diabetic wound care by the National Alliance of Wound Care and Ostomy Watertown, Wis. Disclosure: All panelists reported they have no relevant financial disclosures.

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It is fair to say that often physicians (and other disciplines of health care) do not know how to stage pressure injuries correctly by National Pressure Injury Advisory Panel guidelines, creating regulatory, legal and reimbursement vulnerabilities.

DR. PARK: ON THE FENCE. There

are severe biases involved in staging that are driven by reimbursement and penalties.

These are useful tools to guide therapies, but are most often used for quality metrics and billing.

Physician involvement in wound evaluation and management is essential to ensure the extent of the wound is considered in the context of the patient’s overall health.

—Christi Cavaliere, MD I believe that most physicians and other health care providers are familiar with and understand the pressure injury staging system as described by the National Pressure Injury Advisory Panel. However, the staging does lend itself to a level of subjectivity among providers, and this fact may lead to regulatory, legal and reimbursement vulnerabilities. In addition, although the ulcer management may be addressed, some details in the documentation may be overlooked. Considering these patients often have numerous comorbidities and active medical and social issues requiring attention, the provider may be distracted in a detailed description of findings while addressing the continued abundance of documentation, charting and reporting.

DR. CORDOVA: DISAGREE.

MARCH 2021 / GENERAL SURGERY NEWS

➌

EXTENDED WOUND CARE COVERAGE

Dakin’s solution, vinegar and saline still have a vital role in wound care.

Despite the plethora of wound care products on the market, these continue to perhaps be the most costeffective and have proven the test of time.

“Wound” is an incredibly broad diagnosis and therefore wound treatment must be tailored to the specific wound. Over the past several years, moist gauze dressings or “wet to dry” dressings have been denounced in favor of “advanced wound dressings.” Many of these “advanced” dressings are absorptive—meant to be changed less frequently—and may be relatively expensive. A large, infected wound with necrotic tissue needs to be washed/ irrigated, the necrotic tissue needs to be removed, and more frequent dressing changes may be needed.

These solutions can be used for irrigation and/or packing and can help debride necrotic tissue, making them a valuable tool. Even with use of advanced wound dressings, these products can be used to irrigate and clean a wound. More concentrated solutions may irritate the tissue or slow healing; however, dilute solutions are well tolerated. The solutions are relatively inexpensive and can be prepared in the kitchen, making them accessible to patients who have limited resources or lack insurance coverage for dressing supplies.

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DR. CAVALIERE: AGREE.

[I have] seen tiny tubes of unguents sold for thousands of dollars, only to be discredited, with many patients having paid out of pocket. Simple, cheap and effective therapies always lose out to the ‘latest, greatest’ thing.

—Woo Sup Michael Park, MD Changing the chemical environment of a wound, irrigation, decontamination—all of these agents have a role and have over a century-long track record. That they are cheap and not reimbursed may be one of the reasons why they have been discarded.

DR. PARK: AGREE.

Saline definitely still has a role in modern wound care except in the neonate. The pendulum is shifting away from utilizing Dakin’s and dilute acetic acid (vinegar) as antimicrobial agents and replacing them with newer, other commercial products.

However, Dakin’s and acetic acid are still being used. If so, they should be used correctly. Dakin’s is only effective against gram-positive organisms and needs to be applied twice a day. Acetic acid is effective against both gram-positive and gram-negative organisms, especially Pseudomonas, and needs to be applied three times a day.

DR. WOLLHEIM: ON THE FENCE.

Dakin’s, vinegar and saline play a vital role in wound care. Dakin’s and vinegar have proven bactericidal and fungicidal properties. However, their use should be for a limited period of time as it may cause fibroblast cytotoxicity and paradoxically impair wound healing. It is important to know that these products are available in different concentrations, and those that are more dilute still remain effective and have a safer profile while promoting antisepsis with a lesser degree of cytotoxicity. Saline is a simple, more physiologic, and efficacious solution that provides a moist environment conducive for adequate wound healing. These solutions are all highly accessible, cost-effective and successful in debridement.

DR. CORDOVA: AGREE.

The bar is too low for bringing wound products to the marketplace based on classification as devices and not drugs.

DR. PARK: AGREE,

having seen tiny tubes of unguents sold for thousands of dollars, only to be discredited, with many patients having paid out of pocket. Simple, cheap and effective therapies always lose out to the “latest, greatest” thing.

DR. CAVALIERE: ON THE FENCE. There

are numerous woundrelated products with grand efficacy claims and limited data. This scenario makes choosing products challenging and puts frustrated physicians and suffering patients in a vulnerable position. Products that are low risk and relatively inexpensive may be appropriate to try even with limited data. Unfortunately, many patients assume economic hardship with the hope that a fancy new product will help them heal. A more rigorous and uniform process to evaluate wound products and to assess comparative efficacy would promote more cost-conscious wound care and improve outcomes.

If a new product is not a medication and does not need to undergo the scrutiny of a drug, then I think the nondrug product should be made available for the clinician’s use. All wounds are different, and maybe a newer product might have a unique quality to heal the wound in comparison with other established products in the same category.

The clinician should follow the trajectory of healing regardless of if the product is new or old to the marketplace. In general, the clinician should see a positive response within two weeks, such as a 10% per week decrease in the wound’s cross-sectional area, a decrease in the amount of nonviable tissue compared with viable tissue in the wound bed, and/or maybe less pain, among other parameters. If there is no improvement, then the clinician should consider moving on to a different therapy, be it from an old or new product/therapy.

Early Antibiotics for Sepsis Don’t Result In Overall Higher Use

By ETHAN COVEY

D

ecreasing the time it takes to deliver antibiotic therapy to patients with sepsis does not necessarily correspond to an overuse or misuse of antibiotics, according to data presented at the SCCM’s 50th Critical Care Congress (abstract 38).

“A variety of programs have incentivized rapid antibiotic treatment for severe sepsis, but at the same time, there has been growing concern that earlier antibiotic timing for sepsis may result in increased antibiotic treatment for more patients overall, including those without infection,” said Sarah M. Seelye, PhD, a data scientist with the VA Center for Clinical Management Research, in Ann Arbor, Mich.

To date, however, there has been little evidence to support this claim.

DR. WOLLHEIM: DISAGREE.

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Access to hyperbaric therapy for acutely sick patients is a problem with no real solution in sight.

There is not enough data to understand if a wound would have healed with optimal vascularity, surgical management and excellent wound care, with or without afternoons spent in a tank.

DR. PARK: ON THE FENCE.

AGREE. Hyperbaric oxygen therapy [HBOT] clinics are very expensive to establish, and the administration of the therapy requires its own unique expertise. Although it would be great for all patients to readily have access to HBOT, not all geographic areas can support its use. For the acutely ill patient who does not live in a region where HBOT is readily available, this might require them to be transferred to a hospital, long-term acute care hospital or long-term care facility, with an admission lasting several weeks. This could create a hardship for family members, too. “No real solution in sight” might be an understatement.

■ DR. WOLLHEIM:

Dr. Seelye and her colleagues investigated whether hospital-level acceleration in antibiotic timing for sepsis is associated with increased antibiotic use among all patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential sepsis infection, which took place in 132 Veterans Health Administration hospitals during 2013-2018.

More than half (55.2%) of these patients received antibiotics within 48 hours of emergency department (ED) admission, and 10.7% met the criteria for sepsis.

During the study period, a marked acceleration in time to antibiotics was seen, with the median time to antibiotics among sepsis hospitalizations declining from 5.8 hours in 2013 to 4.8 hours in 2018. This acceleration was seen in 84% of the surveyed hospitals, she said.

However, no association was found between changes in the timing of antibiotic delivery and total antibiotic use among patients with potential infection. In 2013, approximately 57% of patients with potential infection were treated with antibiotics within the first 48 hours following ED arrival. By 2018, the percentage had declined to 55%.

“Despite this acceleration in antibiotic timing for sepsis, we found no evidence that changes in time to antibiotics for sepsis were associated with rising antibiotic use among all hospitalizations for potential sepsis,” Dr. Seelye said.

■

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IN THE NEWS

NPWT continued from page 15

from the wound bed (Plast Reconstr Surg 2006;118[2]:390-397; J Trauma 2011;71[1 suppl]:S147-S150). However, research indicates the technique may not eliminate bacteria effectively enough in complex wounds (J Wound Care 2016;25[8]:475-478).

That’s where instillation and dwell time come in.

“With NPWT plus instillation and dwell time, you’re constantly washing out the wound,” Dr. Matthews, a program director of the burn surgery fellowship at the Arizona Burn Center and an associate professor of surgery at Creighton University, in Omaha, Neb., and the University of Arizona, told General Surgery News. “Over a few days, this process does your debridement for you and leads to a better, more granulated wound bed for an eventual skin graft.”

A growing body of evidence suggests that adding instillation and dwell time to standard NPWT leads to faster healing, fewer operative visits, shorter length of stay and higher rates of closure before discharge in complex wounds (Wounds 2020;32:279-282; Plast Reconstr Surg 2014;133[3]:709-716).

Despite these findings, the adjunctive therapy has not been widely adopted. A main barrier, according to Dr. Matthews, is that case series dominate the literature. “Those who use the technique feel there’s a decided difference in patient outcomes, but there has been no definitive proof,” he said. In other words, “we didn’t have randomized controlled trials.”

At the 2020 Symposium on Advanced Wound Care (SAWC) annual meeting, Dr. Matthews discussed the latest research, which included the first randomized controlled trial of NPWT, and barriers to implementation.

In June 2020, surgeons published a randomized controlled trial that compared 69 patients receiving NPWT with instillation and dwell time and 63 on NPWT (Int Wound J 2020;17:11941208). The instillation group exhibited a significant decrease in bacterial counts after the initial surgical debridement and a lower risk for rehospitalization (three vs. nine patients), although there were no significant differences in the number of debridements, time to wound closure or wound complications.

Paul J. Kim, DPM, who led the effort, noted that the lack of significant difference in the number of debridements was “somewhat unexpected,” given previous study findings and his own experience.

But he pointed to several drawbacks— including the use of polyhexamethylene antiseptic to irrigate the wounds, which may have slowed granulation tissue formation, and protocol variations across

GENERAL SURGERY NEWS / MARCH 2021

institutions—that may have affected the results.

Two other studies published in 2020 aligned more closely with the case series literature. A meta-analysis of 13 studies, which Dr. Kim presented at the SAWC meeting, showed patients receiving NPWT with instillation had significantly fewer surgical debridements, reduced bacterial burden and shorter duration of therapy (1.5 vs. 3.5 days) than those receiving NPWT alone or conventional dressings. Additionally, a 2020 retrospective analysis found that 42 patients undergoing instillation with saline had

A growing body of evidence suggests that adding instillation and dwell time to standard NPWT leads to faster healing, fewer operative visits, shorter length of stay and higher rates of closure before discharge in complex wounds.

significantly fewer operations, shorter length of stay and higher percentage of closed wounds than the 74 patients receiving NPWT (Cureus 2020. doi: 10.7759/cureus.9047).

Dr. Matthews called the retrospective analysis “groundbreaking,” noting it “should be a game changer for wound care.”

After reviewing the 2020 research, Dr. Matthews detailed his own experience.

For his third-degree burn patient, he described covering the wound bed with a reticulated open-cell foam dressing with through holes to aid the removal of

IN COMPLEX HERNIA REPAIR, PATIENT RISK FACTORS AND POSTOPERATIVE WOUND COMPLICATIONS CAN CONTRIBUTE TO THE PERIL OF HERNIA RECURRENCE

INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.

For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

MARCH 2021 / GENERAL SURGERY NEWS

EXTENDED WOUND CARE COVERAGE

exudate and then irrigating the wound with a solution of hypochlorous acid for 20 minutes, followed by negative pressure for 160 minutes. This three-hour cycle was repeated for several days, at which point Dr. Matthews applied a fresh dressing. Ultimately, the patient required five operations interspersed with NPWT with instillation until granulation tissue began to form and an autograft could be placed.

Consensus guidelines, published last year, provide a framework for when to use this technique, which includes fullthickness burns after excision as well as

traumatic, infected and diabetic wounds (Int Wound J 2020;17[1]:174-186). Still, wound care experts have been slow to adopt NPWT with instillation. According to Dr. Kim, the medical director of the Wound Program at The University of Texas Southwestern Medical Center, in Dallas, the perception that standard NPWT “is good enough” and instillation “adds greater complexity” represents a major hurdle.

Luis G. Fernández, MD, a trauma surgeon, believes the mentality of “we’ve always done it this way” is often a barrier to the development of innovative

approaches that may benefit patients.

“It’s human nature to fear change, and it takes time and effort to learn and adapt to a new paradigm,” said Dr. Fernández, the medical director of trauma wound care and a professor of surgery at The University of Texas Health Science Center, in Tyler.

Alex Wong, MD, who was not involved in the research, noted that NPWT alone may be the instinctive first choice for surgeons based on accessibility and familiarity, but he sees the advantages of adding instillation. “The data on NPWT with instillation looks solid

and consistent, and intuitively it makes sense to clean the wound more,” said Dr. Wong, an associate professor of surgery in the Division of Plastic and Reconstructive Surgery at the University of Southern California’s Keck School of Medicine, in Los Angeles. “After reviewing the evidence and updated consensus guidelines, I may increase my use of NPWT plus instillation.”

■ The SAWC talk was supported by an educational grant from 3M+KCI. Drs. Fernández, Kim and Matthews reported relationships with the company.

Update on Surgical Smoke

STRATTICE™ RTM, a 100% biologic mesh, is a durable solution for abdominal wall reconstruction based on the long-term outcomes of low hernia recurrence rates across multiple published clinical studies1-5 In a recent retrospective evaluation, biologic meshes were shown to have a

CUMULATIVE HERNIA RECURRENCE RATE OF

8.3

%

AT

7 YEARS POST-OP1,*

*Includes porcine and bovine acellular dermal matrices (ADMs) (n = 157).

Bridged repair and human ADM were excluded from the study group.

TO LEARN MORE ABOUT STRATTICE™ RTM, SPEAK TO YOUR ALLERGAN REPRESENTATIVE PRECAUTIONS (Continued) Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.

For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.

For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.

STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.

For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

For more information, please call Allergan Customer Service at 1.800.367.5737, or visit www.StratticeTissueMatrix.com/hcp.

References: 1. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350.

2. Golla D, Russo CC. Outcomes following placement of non-cross-linked porcine-derived acellular dermal matrix in complex ventral hernia repair. Int Surg. 2014;99(3):235-240. 3. Liang MK, Berger RL, Nguyen MT, Hicks SC, Li LT, Leong M. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture in complicated open ventral hernia repair. Surg Infect (Larchmt). 2014;15(5):506512. 4. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J Am Coll Surg. 2013;217(6):9991009. 5. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014;80(8):725-731.

Allergan® and its design are trademarks of Allergan, Inc. STRAT TICE™ and its design are trademarks of LifeCell Corporation, an Allergan affiliate. © 2019 Allergan. All rights reserved. STM122131 03/19

An increasing amount of research confirms that surgical smoke can contain toxic gases and vapors such as benzene, hydrogen cyanide, formaldehyde and bioaerosols, as well as live cellular material and viruses (http://bit.ly/3qfQCc8).

“While exposure of surgical smoke to patients is short term and relatively low risk, surgeons, perioperative nurses and other operating room staff are exposed to surgical smoke daily,” Ana Pujols McKee, MD, the executive vice president, chief medical officer, and chief diversity and inclusion officer at the Joint Commission, said in a press release. “At high concentrations, surgical smoke may cause ocular and upper respiratory tract irritation and potentially create visual problems for the surgeon. This is why it is so important for hospitals and ambulatory surgery centers to be aware of the risks of surgical smoke and how they can best mitigate those risks.”

The literature reveals that nanoparticles comprise 80% of surgical smoke and are the real danger in inhaled smoke (Biointerphases 2007;2[4]:MR17MR71). These particles are less than 100 nanometers in size (i.e., 0.1 micron), and when inhaled, enter a person’s blood and lymphatic circulatory systems and travel to distant organs (Circulation 2002;105[4]:411-414).

In an effort to keep health care workers up-to-date, the Joint Commission recently published a new advisory, “Alleviating the dangers of surgical smoke,” which reviews current regulations, recommendations and standards from several governmental and professional organizations.

To view the guidelines, and several safety actions, go to http://bit.ly/3oGSPgd. ■

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OPINION

SSIs: What Surgeons Should Know About Their Hospital’s Cleaning Program

By DAVID TAYLOR, MSN, RN, CNOR

M

any patients experience pain postoperatively related to their surgery.

Unfortunately, far too many operations result in a surgical site infection (SSI).

Doctors and hospitals may say infections following surgeries are a potential risk, but for many, postsurgical infections can be the result of contaminated treating

environments and/or negligence. In the United States, approximately 27 million surgical procedures are performed each year, with as many as 5% of those resulting in an SSI.1 Contamination within an OR can be introduced through a variety of sources: surgical instruments and equipment, personnel and the patient, inanimate objects and surfaces, the air and even insects,

potentially causing harm. To provide a safe environment for both the patient and health care worker, an environmental control program should be established for the OR to keep microorganisms to a minimum.

In 2017, the American College of Surgeons and Surgical Infection Society published SSI guidelines found that they are the most common and costly type of

Successfully Treat Non-healing Wounds Safely at Home Multimodality Topical Wound Oxygen (TWO2) therapy explained: • Delivering the highest level of topical oxygen supplementation to non-healing wounds = greater & more durable healing1 • Cyclical-pressure noncontact compression delivery = addresses edema & underlying peripheral vascular disease2 • Humidification = maintains moist wound environment & facilitates healing3

1 R.G. Frykberg. et. al., “Multinational, Multicenter, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers,” Diabetes Care, vol. 43, no. 3, p. 616–624, 2020.

2 W. Tawfick, S. Sultan, “Technical and clinical outcome of topical wound oxygen in comparison to conventional compression dressings in the management of refractory nonhealing venous ulcers,” Vasc Endovascular Surg, vol. 43, p. 30–37, 2013.

3 J.P. Junker. et. al, “Clinical Impact Upon Wound Healing and Inflammation in Moist, Wet, and Dry Environments,” Advances in Wound Care, vol. 2, no. 7, pp. 348-356, 2013.

www.aotinc.net Learn more about TWO2, the next generation of multi-modality topical oxygen wound therapy

health care‒associated infection (HAI) and accounted for 20% of all HAIs. The annual incidence of SSI in the United States is between 160,000 and 300,000, or 2% to 5% of patients undergoing inpatient surgery, and the attributable health care cost ranges from $3.5 billion to $10 billion annually. On average, an SSI increases a hospital length of stay by 9.7 days.2 The recommendations put forth by the Association for peri-Operative Registered Nurses, and the Association for the Healthcare Environment’s Practice Guidance for Healthcare Environmental Cleaning, are the standards used by most health care facilities in setting up their infection prevention procedures regarding the OR and other procedural spaces.

However, as a consultant, I have provided hundreds of OR assessments across the country, and have often found cleanliness and infection prevention practices to be lacking. Preoperative leaders are not maintaining their ORs to industry standards, and after interviewing surgeons they had no clue of the problems.

Cleaning measures are needed before, during and after surgical procedures (in between procedures), and at the end of each day. Such cleaning must be considered an environmental essential, and infection prevention considerations should include the following: Air handling or ventilation systems of the surgical suite should be designed to minimize contaminants. Air entering the room through the HVAC system should originate from the ceiling and exit through the return near or at the floor. Air exchanges should be a minimum of 15 per hour with at least four of those air exchanges originating from a fresh air source, and be HEPA filtered.

Many hospitals have increased their air exchange rates to as high as 25 per hour with 100% of those being fresh air.

Proper attire (scrubs) should be freshly laundered and donned at the hospital to reduce the number of contaminants carried in from outside of the OR. Because scrubs are considered a form of personal protective equipment, they should be

Ultraviolet disinfection.

taken off prior to health care workers leaving for the day.

Traffic during the operation should be confined to the members assigned to that procedure. The microbial levels in the air are directly proportional to the number of people moving about and talking within the OR. Minimizing the number of people in the room, or how many times members of the team enter or exit throughout the procedure can help reduce infection rates.

Bloodborne pathogens have the potential to be infectious, as well as other body fluids including saliva; cerebrospinal, synovial, pleural, pericardial, peritoneal and amniotic fluids; semen; and vaginal secretions. Caution should be taken when handling specimens, organs (other than intact skin), and cell or tissue cultures.

EXTENDED WOUND CARE COVERAGE

to as UV germicidal irradiation. Many companies are now offering this technology for use in hospitals and other industries. In the wake of the COVID19 pandemic, UV technology has been used more extensively, but unfortunately there are limitations for its use. Because UV radiation exposure is hazardous to humans, it is typically used in one of four configurations: in unoccupied room disinfection, upper room disinfection, air handler unit surface disinfection and air handler surface airstream disinfection.4 Whether or not an infection rises to the level of medical malpractice

will depend on the circumstances surrounding how and when the infection occurred. Medical malpractice cases can be difficult to prove; nevertheless, surgeons should be aware of preventive measures and call on their hospital leadership to do everything in their power to ensure patients remain safe and free of infection.

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References

1. Hospital infection control: surgical site infections. http://bit.ly/3qYmYbX 2. Ban KA, Minei JP, Laronga C, et al.

American College of Surgeons/Surgical

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Infection Society surgical site infection guidelines‒2016 update. Surg Infect (Larchmt). 2017;18(4):379-382.

3. Indoor air quality: what are the trends in indoor air quality and their effects on human health? http://bit.ly/2O1UNKX 4. UVGI vs. BPI: which air-cleaning technology is best for your building? http://bit.ly/3bHUfBZ

—David L. Taylor III, MSN, RN, CNOR, is the principal of Resolute Advisory Group, LLC, a health care consulting firm in San Antonio.

He can be reached at DavidTaylor@ ResoluteAdvisoryGroup.com.

NOBODY LIKES DOING IT OVER.

Employing New Technologies New technologies are designed to help keep ORs cleaner and can include products with ultraviolet light and advances in heating, ventilation and HVAC systems, such as needlepoint bipolar air ionization (NPBI) technology. What are the pros and cons of using these technologies?

According to the Environmental Protection Agency, indoor air can be two to five times more polluted than outside air.3 A newer technology, NPBI produces a high concentration of positive and negative ions, which allows similarly charged particles to combine (get larger), making it easier for them to be filtered more effectively. Basically, as the ions travel within the airstream, they attach to pathogens, particles and gas molecules, breaking them down and rendering them ineffective.

Ultraviolet light technology has been thoroughly vetted and has a proven track record since the 1940s. The technology works by using UV-C band wavelength to degrade organic material and inactivating microorganisms and pathogens.

Use of the UV-C band energy to inactivate microorganisms is often referred

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GENERAL SURGERY NEWS / MARCH 2021

Wound Care: Rewarding Work continued from page 15

oxygen care,” said John Lantis, MD, a professor of surgery at Mount Sinai Hospital, in New York City. “In most cases, these centers are run by a for-profit company that forms a partnership with a local hospital system. The for-profit company and the hospital determine who pays which employees and who pays for the development of the space.

In addition, the hospital system benefits from the ancillary spinoffs.”

According to Dr. Lantis, “in that model,

podiatrists have thrived; there are also providers in infectious disease, emergency medicine, physical medicine and rehabilitation, and general medicine.” However, even though there are certifications for wound care from organizations such as the American College of Wound Specialists, they don’t meet the level of rigor demanded by institutions like the American Board of Medical Specialties, he said.

“The organizations that give certificates may differentiate in which

‘There is a core knowledge you need to know: what you’re doing and why you’re doing it. The concept of just starting to do wound care is a bit like deciding to do laparoscopy without any training in it.’

—John Lantis, MD certification they give to different levels of training, but they will certify a medical assistant, a nurse, a physical therapist, a doctor—therefore, ownership is diverse,” Dr. Lantis noted.

So, apparently, is the quality of care.

Wound care technology has advanced significantly, but overall outcomes are often subpar, sometimes as low as a 50%

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to 60% healing rate at six months. “That may be due to people not following algorithms and really not knowing what they’re doing,” Dr. Lantis said.

Since a large part of wound care is pain control and wound debridement, general surgeons may be better equipped than nonsurgical specialists to treat these wounds, he said. Especially in the outpatient setting, this can be well reimbursed.

“But there is a core knowledge you need to know: what you’re doing and why you’re doing it. The concept of just starting to do wound care is a bit like deciding to do laparoscopy without any training in it,” Dr. Lantis said.

The application and use of cellular tissue-based products (i.e., skin substitutes), which many surgeons know from the operating room, also can be remunerative. “But again, you need to be familiar with their use, handling, indications and expected outcomes,” Dr. Lantis added.

Basics of Starting Out Any general surgeon getting into wound care will face some up-front costs: acquiring the appropriate products for debridement and postprocedural advanced dressings, and possibly reinforcing the front office staff, Dr. Lantis said.

“You may want to partner with someone more familiar with those dressings, such as a wound and ostomy care nurse.

Also, home care provides a large amount of wound care, so you’ll need be able to handle the demands of communication coordination with home care and home care nurses,” he added.

An easy way to get your feet wet is to look up nearby wound care centers.

Many are staffed five or six days per week, in half-day shifts, allowing for 10 to 12 blocks per week. Tell them you’re a boardcertified general surgeon interested in doing two or three days weekly and ask if they have any openings. These wound care programs usually offer structured training and provide algorithms for care.

“That’s like buying a mutual fund.

It minimizes your risk while maximizing your productivity, and enhances the general surgeon’s ability to provide good care,” Dr. Lantis said.

Another relatively easy entrance is to develop an on-call schedule for wound care at your local hospital. “Most hospitals would love to have a general surgeon rounding, where they could, say, call the general surgery service for any skin issues,” Dr. Brem said. “This could be separate from their regular general surgeon or wound care nurse on call or in collaboration with those services.”

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MARCH 2021 / GENERAL SURGERY NEWS

EXTENDED WOUND CARE COVERAGE

Understanding Reimbursement for Wound Care

By Monica J. Smith Several times per week, Kathleen D. Schaum, MS, a wound care reimbursement strategy consultant, fields phone calls from health care providers asking, “How can I get paid by Medicare for that?”

At the 2020 fall Symposium on Advanced Wound Care, Ms. Schaum, the founder and president of Kathleen D. Schaum & Associates, Inc., said the answer to this question requires understanding the three components of reimbursement: coding, coverage and payment that pertains to each specific scenario.

To determine clients’ potential for reimbursement, she asks them to focus on a few details. As an example, a client seeks Medicare reimbursement for negative wound pressure therapy. In this case, the questions are: “Are they using durable medical equipment or disposable negative pressure?

Who is applying the negative pressure? What is the site of care?

If another procedure will take place concurrently, what is that other procedure?”

In addition, there are other considerations, Ms. Schaum said. Medicare may reimburse: • if the procedure is covered for that patient. Since not every technology can be applied to every patient, Ms. Schaum advised checking National Coverage Determinations, Local Coverage Determinations and Local Coding Articles on the Centers for Medicare & Medicaid Services’ website (see links below).

“Physicians and qualified health care professionals often say, ‘Isn’t this the coder’s job? I don’t have time to read these.’ But I’ll tell you, these things are not that long and they are the playbook for physicians and qualified health care professionals,” Ms. Schaum said.

• if the physician performed the procedure. For example, if the physician provides wound/ulcer management in a hospital– owned, outpatient provider-based department, that physician “can bill for it if he/she performed the procedure. But if they write an order for a department staff member to perform it, only the facility can bill for it.”

• if the service/procedure is not part of a National Correct Coding Initiative procedure-to-procedure (NCCI PTP) edit. When two services/procedures are performed during the same encounter, verify whether an NCCI PTP edit exists that would cause payment denial for one of the services/procedures.

• if the procedure is not included in the consolidated bill payment system of a skilled nursing facility.

Many wound and ulcer patients are in skilled nursing facilities, which submit consolidated bills to Medicare and get paid a lump sum for their patients’ care.

“So, you’ll need to know which procedures are in the consolidated billing system and which are not,” Ms. Schaum said. For the latter, you can bill Medicare; for the former, you’ll have to contract with the facility to bill them for that work.

Resources From the CMS Website • PTP Coding Edits http://go.cms.gov/3uCkcvi • How to Use the Medicare National Correct Coding Initiative https://go.cms.gov/2O7ONju • Overview on Skilled Nursing Facility Consolidated Billing http://go.cms.gov/3e2bBwn • 2021 Part B MAC Update http://go.cms.gov/3kz5ZLe

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