A 12-Month Retrospective Review of Pressure Injury Plastic Surgical Flap Techniques Utilizing Pure Hypochlorous Acid (pHA) Preserved Wound Solution for Wound Bed Preparation

The worldwide incidence of pressure injuries (PIs) in the inpatient setting is 12%.¹ PIs are staged I to IV based on injury depth, with stage IV PIs being full-thickness soft tissue defects with exposed tendon, muscle, and/or bone.²Despite constituting the smallest incidence of PIs reported in hospitalized patients (1-4%), stage IV PIs account for 58% of PI-associated healthcare costs.^1,3,4 The annual treatment cost for PIs in the United States is $10 billion to $11 billion.⁵ The primary drivers of cost are the personnel and materials necessary for conservative wound management, consisting of local debridement and dressing changes.⁵ However, because of the severity of stage IV PIs, these wounds are often refractory to conservative management and require surgical reconstruction, consisting of excision of all infected and nonviable tissue and advanced plastic surgery techniques for closure.⁶ While early treatment and surgical intervention have been postulated to be factors that may help reduce health care expenditure, surgeons may be reluctant to proceed with surgical intervention in eligible patients due to the high reported rates of postoperative complications and wound recurrence following surgical intervention.⁷

Surgical management of chronic stage IV PIs is complex, with reported rates of postoperative complications ranging from 16% to 44%^6,8-11 and wound recurrence rates ranging from 23% to 52%.^12-14 The presence of heavy microbial colony formation, polymicrobial infection, and altered pH are contributing factors to these reported rates.^6,15-17 As such, the surgical protocol employed in the management of these ulcerations should include steps to mitigate the negative effects of local bacterial burden and altered pH. The use of pHA as a cleansing solution in the management of wounds is recommended by the World Health Organization¹⁸ and current National Pressure Injury Advisory Panel guidelines.¹⁹ This recommendation is based on research demonstrating that pHA is non-cytotoxic, has antimicrobial properties, and can enhance healing.^18,20,21 The objective of the current study was to report the rate of bacteria-related postoperative complications in all patients who, over the period of 1 year, presented with chronic stage IV PIs and subsequently underwent surgical reconstruction following a comprehensive surgical treatment protocol that included use of a pHA antimicrobially preserved wound cleansing solution (VASHE wound solution, Urgo Medical, Fort Worth, TX) for wound bed preparation. The results of all consecutive patients who met these criteria are reported here.

The Internal Review Board at Tulane University School of Medicine approved the retrospective review of all consecutive patients with a chronic stage IV PI who underwent surgical reconstructive procedures for closure between January 2022 and December 2022. All surgical reconstructive procedures were performed at a single academic medical center by a single plastic surgeon. Patients underwent general anesthesia and were placed in an operative position that would be the most accommodating for access to the PI and flap donor site. Two surgical instrument set-ups were used for the procedure. The first was used for excision of the soft tissue defect and all nonviable tissue, including bone when necessary. Methylene blue was used as an adjunct to visual inspection to identify nonviable tissue for resection. Viable cells will oxidize methylene blue, rendering it colorless and leaving nonviable tissue readily identifiable for resection.²² While the data are limited and no standardized recommendations exist on the wound types and methods of application in which methylene blue can be used to guide debridement, this method of debridement in PIs has been reported to result in a significantly lower risk of flap failure and was not associated with any adverse outcomes.^22-25 Soft tissue and bone specimens for culture and sensitivity were obtained following excision. The operative site was then irrigated with the pHA antimicrobially preserved wound cleansing solution using a bulb syringe followed by packing of the soft tissue defect with a pHA antimicrobially preserved wound cleansing solution-soaked laparotomy sponge, which was left in place for 8 to 10 minutes. Following removal of the sponge, the length, width, and depth of the remaining defect were measured for flap planning and closure. The second surgical instrument set-up was then used to elevate the flap selected for reconstruction. The flap was placed to fill and cover the soft tissue void. Layered closure was then performed over ≥15 French Blake drain, depending on the size of the surgical site. Then, iNPWT set at -125 mm Hg continuous pressure was placed over the incision site. The first dressing change occurred between postoperative days 3 and 4. The iNPWT was left in place for the first 2 weeks postoperative, with dressing changes performed every 2 to 3 days.

The postoperative management protocol consisted of maintaining patients on complete bedrest on an air fluidized sand bed for offloading with 1:1 or 1:2 nursing for assistance. Patients were admitted by Primary Care for medical management. Systemic antibiotic therapy was administered based on the recommendations provided by Infectious Disease. Patients remained hospitalized for an average of 5 days for postoperative care followed by discharge to a long-term care facility for a minimum of 4 weeks. A progressive sitting protocol was started at 3 weeks postoperative in which patients sat for 5 minutes with assessment of the surgical site by a physical therapist for signs of erythema or intolerance before and after the sitting session, progressing to sitting for 30 minutes at the time of discharge.

Thirteen patients (12 male, 1 female) with 18 chronic stage IV PIs underwent surgical management during the study period (Table). The mean patient age was 51.1 ± 15.5 years. The PI locations were sacral (n=9), left ischial tuberosity (n=5), right ischial tuberosity (n=3), and trochanteric (n=1). The average wound area was 132.6 ± 90.0 cm² (range: 35-560 cm²). The average wound volume was 534 ± 291.5 cm³ (range: 70-1120 cm³). The PIs in 12 (92.3%) patients were complicated by osteomyelitis. A total of 40 reconstructive surgical flaps were used for closure: right gluteus fasciocutaneous advancement flap (n=8), right gluteus muscle advancement flap (n=6), left gluteus muscle advancement flap (n=5), left gluteus fasciocutaneous advancement flap (n=4), left hamstring muscle advancement flap (n=4), right hamstring muscle advancement flap (n=3), left gluteus muscle rotation flap (n=2), left gluteus myocutaneous rotation flap (n=2; 1 with use of an ovine forestomach xenograft [Myriad Matrix, Aroa Biosurgical Limited, San Diego, CA] as an implant); left and right gluteus fasciocutaneous advancement flap (n=2); left gluteus myocutaneous rotation flap (n=1); right gluteus muscle rotation flap (n=1); right myocutaneous advancement flap (n=1); and revisional thigh fasciocutaneous flap (n=1). Ten of the 18 (55.6%) wounds had a positive wound culture. Bacteria identified on intraoperative cultures were Bacteroides, Diphtheroid, Enterobacter cloacae, E. faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus, P. mirabilis, P. vulgaris, Staphylococcus epidermidis, and S. lugdunesis.

Postoperative complications occurred in 2 patients (2/13, 15.4%). One postoperative complication, a bleeding event that required transfusion in a patient on anticoagulant therapy for an upper extremity deep venous thrombosis, was deemed unrelated to the local bacterial burden of the wound. One patient (1/13, 7.7%) with an intraoperative culture positive for extended spectrum beta-lactamases-producing E. faecalis had a postoperative dehiscence requiring reoperation (Figure 1). This postoperative complication was deemed potentially related to the local bacterial content of the wound with continued cultures positive for E. faecalis, E. raffinosus, methicillin-resistant Staphylococcus, and Acinetobacter baumannii identified from cultures obtained during the reoperation procedure. None of the other 9 patients (90.0%) with pre-irrigation and indwelling of the pHA antimicrobially preserved wound cleansing solution and intraoperative cultures positive for bacterial growth had a postoperative complication potentially related to residual bacteria within the surgical site (Figure 2). The potentially bacteria-related postoperative complication rate per procedure was 2.7% (1/37). All cases complicated by osteomyelitis had resolution of osteomyelitis with the combined surgical and systemic antibiotic therapy protocol employed.

All consecutive patients presenting to a single facility over a 1-year period with a chronic stage IV PI treated with surgical reconstruction, which included irrigation and indwelling of a pHA antimicrobially preserved wound cleansing solution prior to advanced plastic surgery techniques for closure, had a 7.7% (per patient; 2.7% per procedure) postoperative complication rate potentially related to bacterial burden within the wound. This postoperative complication rate is lower than those reported in other studies.^6,8-11 In retrospective reviews ranging from 5-10 years (n, patients, range: 15-117), postoperative complication rates following surgical reconstruction of stage III or IV PIs range from 16% to 44%.^6,8-11 The most common postoperative complication reported was partial or full incisional dehiscence.^6,9,10 Identified risk factors associated with postoperative complications include a prior history of PI at the same site, a higher American Society of Anesthesiologists score, elevated C-reactive protein levels, low albumin levels, larger wound size, reconstruction with a musculocutaneous flap, and bacterial content within the wound bed.^6,11,17 While bacteria within the wound bed was not found to have a statistically significant association with early incisional dehiscence in 1 study, the authors still concluded that wound infection was the cause of early incisional dehiscence, as all wounds with this postoperative complication had bacteria detected within the wound bed.¹¹ One 4-year, single-center, retrospective observational study evaluated the bacterial content and associated postoperative complications in 61 patients who underwent surgical intervention for treatment of stage IV PIs complicated by osteomyelitis.²⁶ Surgical management was performed in a 2-stage approach with initial excision of nonviable and infected tissue followed by reconstructive flap procedures for wound closure. The most prevalent bacteria identified from intraoperative cultures following debridement were Staphylococcus (57.8%), including methicillin-resistant S. aureus (MRSA); Enterobacteriaceae (43.8%); anaerobes (similar proportion to Enterobacteriaceae, exact percentage not reported), and Streptococci (37.5%). A statistically significant increase in coagulase negative Staphylococcus, Enterobacteriaceae—particularly in patients in whom fluoroquinolones had been administered in the prior 6 months—and Candida was noted on cultures obtained prior to flap reconstruction. This was observed despite administration of a median of 19.8 weeks of antibiotic therapy, with a median of 11.1 weeks of antibiotic therapy received following reconstruction. The authors recommended a 2-stage approach to surgical intervention, consisting of initial excision of nonviable and infected tissue to reduce local bacterial load followed by flap closure, despite identifying residual bacteria within the wound bed at the time of the second procedure.

Understanding the reported risk of postoperative complication following surgical reconstruction of chronic stage IV PIs led the authors of the current study to implement irrigation and 8- to 10-minute indwelling of a pHA antimicrobially preserved wound cleansing solution to their surgical management protocol. The goal of pHA antimicrobially preserved wound cleansing solution use was to help eradicate heavy wound colonization and lower the wound pH to that of uninjured skin to mitigate postoperative complications related to residual bacterial presence and assist with wound healing. Hypochlorous acid is a component of the innate immune response, aiding in pathogen killing via the neutrophil oxidative burst.²⁰ A stabilized hypochlorous acid solution has been shown to have bactericidal effects on planktonic bacteria, adherent microbial colonies, and fungal strains, including E. cloacae, K. pneumoniae, P. mirabilis, S. aureus, Stenotrophomonas maltophilia, Streptococcus pyogenes, C. glabrata and C. albicans.^20,21 Adherent bacterial colonies—including S. aureus, MRSA, vancomycin-susceptible Enterococcus faecalis, E. cloacae, and fungi—were completely eradicated after 10 minutes of exposure to hypochlorous acid. No observed colonies were seen with colony forming unit analysis of vancomycin-resistant E. faecalis, S. pyogenes, C. glabrata, and E. coli biofilms after 1 minute of exposure to hypochlorous acid. Irrigation with a hypochlorous acid solution demonstrated superior reduction in bacterial counts compared with normal saline irrigation following surgical debridement.²⁷ Irrigation with hypochlorous acid is also more cost-effective compared with irrigation with normal saline, with a 55% reduction in the probability of a wound-related complication and number needed to treat of 2 to avoid 1 wound-related complication.²⁸ Despite the noted bacteria removal effect of hypochlorous acid, the solution is non-cytotoxic as its byproducts are water and chloride salt after its application to the wound.¹⁸ This is in contrast with chlorhexidine, hypochlorite bleach, and povidone-iodine antiseptic products, which all have cytotoxic effects likely associated with their tendency to linger at the application site.¹⁸ Clinical reports of the use of hypochlorous acid in the treatment of intracranial hemorrhage,²⁹ neonatal circumcision,³⁰ chronic wounds,³¹ and autografted burn wounds³² have reported the treatment to be well tolerated with positive clinical outcomes. Use of hypochlorous acid in neonatal circumcision resulted in a significantly reduced rate of edema and wound healing delay compared with the use of povidone iodine.³⁰ Use of a pHA antimicrobially preserved wound cleansing solution in combination with ultrasound debridement reduced bacterial counts in chronic wounds.³¹ No difference in post-grafting healing at Day 14 was noted with the use of the pHA antimicrobially preserved wound cleansing solution compared with a 5% sulfamylon solution in the treatment of autografted burn wounds.³² No adverse events related to the use of hypochlorous acid were noted.

The results seen with use of hypochlorous acid may be due to a combination of factors: hypochlorous acid being part of the innate human immune response, its bacteria removal properties, the non-cytotoxic effects of stabilized hypochlorous acid, and the demonstrated ability of hypochlorous acid to promote keratinocyte and fibroblast migration, which is beneficial to wound healing.³³

Wound pH is an often underappreciated variable that can have an impact on wound healing. Chronic wounds have been reported to be more alkaline, with a pH ranging from 7.15 to 9 compared with intact skin, which has a more acidic pH of 4.2 to 5.5.^15,16 Rates of healing of alkaline acute and chronic wounds have been reported to be delayed compared with wounds with a more neutral to acidic pH.¹⁵ A lower pH has been shown to enhance oxygen delivery, angiogenesis, and macrophage and fibroblast activity while impeding bacterial counts and toxicity.^15,16 Lowering of the local pH with a topical acidic agent, such as the pHA antimicrobially preserved wound cleansing solution used in the current study, may contribute to these positive effects on wound healing.³²

One other case has been reported on the use of another hypochlorous acid preserved wound cleansing solution for irrigation of a perianal abscess following surgical incision and drainage.³⁴ Initial treatment of the patient consisted of irrigation and debridement, systemic ceftazidime and metronidazole therapy, and irrigation of the wound at each dressing change. Wound irrigation was first performed with normal saline and later with a diluted povidone-iodine solution. Despite this treatment, the patient continued to be febrile, express large amounts of exudate, and have cultures positive for E. coli. The decision was made to change the irrigation solution from povidone-iodine to the pHA antimicrobially preserved wound cleansing solution. One day after initiation of irrigation with the pHA antimicrobially preserved wound cleansing solution, the patient’s fever began to subside. After 2 weeks of use, the patient had no growth on cultures obtained. The patient’s wound reduced in volume by >90% 5 weeks following use of the pHA antimicrobially preserved wound cleansing solution for wound irrigation; wound resolution was achieved at 6 weeks. In the cases presented in the current study, only 1 patient had a postoperative complication potentially related to residual bacteria. This complication occurred in the patient with the second largest wound by area. While an ovine implant was used in that patient, the complication was not related to its use but to new and progressive osteomyelitis of the trochanter which required orthopedic surgical intervention. No other patient experienced a postoperative complication potentially related to residual bacteria within the wound site, despite 9 patients having intraoperative cultures positive for growth following debridement.

While the number of patients seems small, the 13 patients presented in the current study represent a relatively large cohort given the low reported rates of stage IV PIs in hospitalized patients^1,3 and surgeon reluctance to perform surgical reconstruction in these patients because of their health status, high reported rates of postoperative complications, and frequent wound recurrence following surgical intervention.⁷ The 13 patients included in the current study represented all of the consecutive patients with a chronic, stage IV PI who underwent surgical intervention at the authors’ institution during the study period; no patient who met the criteria was excluded from this study. Another strength of this study is its demonstration of the potential to reduce potentially bacterial-related postoperative complications following surgical reconstruction of stage IVs, as these wounds compromise the greatest PI-associated healthcare costs, are often refractory to conservative management,^1,3,4 and are associated with high rates of postoperative complications^6,8-11 and recurrence.^12-14 Use of the pHA antimicrobially preserved wound cleansing solution to minimize bacterial burden and lower the pH at the wound site to mitigate bacteria-related postoperative complications has been reported to reduce the number of necessary debridements, repeat surgical interventions, and postoperative complications, as well as shorten operating times, duration of hospitalization, and time to healing.^35,36

Study limitations include the lack of a control group, inclusion of a small number of patients with a specific wound type, and the potential for confounding factors that could also have helped minimize postoperative complications and assist with healing. Future case-control cohort or prospective studies are recommended to allow for comparison of postoperative outcomes of patients who did or did not have adjunctive use of the pHA antimicrobially preserved wound cleansing solution during surgical intervention. It is recommended that future studies enroll larger groups of patients and obtain intraoperative cultures prior to and following irrigation and indwelling of the pHA antimicrobially preserved wound cleansing solution to provide further information on the residual bacterial content within the wound following this treatment. Protocols should also be established to limit other potential confounding variables that could weaken the reported outcomes associated with the use of pHA antimicrobially preserved wound cleansing solution.

The addition of irrigation and an 8- to 10-minute indwelling time of a pHA antimicrobially preserved wound cleansing solution following ulcer excision and prior to flap closure in single-stage surgical reconstruction of chronic stage IV PIs resulted in reduced postoperative complications potentially related to residual bacterial content compared to complication rates in the published literature. Postoperative complications potentially related to residual bacterial burden did not occur in 90% of patients with intraoperative cultures positive for bacterial growth obtained prior to irrigation and indwelling of the pHA antimicrobially preserved wound cleansing solution. The innate bacteria removal properties, non-cytotoxic effects, pH-lowering abilities, and healing assistance associated with the pHA antimicrobially preserved wound cleansing solution make it a valuable adjunct in the surgical management of chronic stage IV PIs. Given the complexity of these wounds and the high potential for postoperative complications to occur, development of surgical management for the treatment of chronic stage IV PIs should employ multiple modalities, as illustrated in this study, to optimize outcomes in this patient population.

Authors: Caleb W. Fligor, MD¹; Abby B. Duplechain, BS²; and Abigail E. Chaffin, MD, FACS, CWSP, MAPWCA³

Affiliations: ¹Department of Surgery, Tulane University School of Medicine, New Orleans, LA; ²Tulane University School of Medicine, New Orleans, LA; ³Chief, Division of Plastic and Reconstructive Surgery, Tulane University School of Medicine, New Orleans, LA

Disclosures: A.C. is a consultant for Urgo Medical North America and for Aroa Biosurgery. C.F. and A.D. have no conflicts of interest to report.

Funding: Urgo North America provided financial support to Valerie Marmolejo, DPM, MS, MWC, with Scriptum Medica, for assistance in preparation of this manuscript.

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