A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis.

BACKGROUND: The RESPOND registry study was the first prospective noninterventional study evaluating the real-world effectiveness of a native type 1 collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) barrier in nonhealing wounds. PURPOSE: The objective of this secondary analysis was to describe the effects of PCMP in the subgroup of patients with venous leg ulcers (VLUs) in the RESPOND registry. METHODS: RESPOND was a 28-site, prospective, noninterventional study for up to 32 weeks. All patients (N = 307) in RESPOND received PCMP. Eligibility criteria included patients being 18 years of age and older and having cutaneous wounds, not including third-degree burns. Kaplan-Meier methods analyzed the frequency and median time to wound closure. RESULTS: For the cohort of PCMP-treated VLUs (n = 67), the mean baseline wound area was 20.07 cm2 and mean wound duration was 89 days. Wound closure frequencies were 33%, 42%, 45%, 53%, and 73% at weeks 8, 12, 16, 24, and 32, respectively. The median time to closure was 22 weeks. Incidences of achieving >60% reduction in baseline area and depth were 78% and 70%, respectively, with 87% showing a reduction of >75% in volume. CONCLUSION: PCMP appears to be a valuable adjunct for treating venous leg ulcers.

Effectiveness of type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of pressure injuries.

INTRODUCTION: The first prospective noninterventional registry study (RESPOND) evaluated the clinical effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial barrier (PCMP) in various nonhealing wounds. This product is intended for the management of partial- and full-thickness wounds and acts as an effective barrier to reduce microbes penetrating through the dressing. The RESPOND study demonstrated that PCMP has clinically meaningful benefits in managing a variety of wounds. OBJECTIVE: The authors describe the effects of PCMP in the subgroup of patients with pressure injuries (PIs) from the RESPOND registry. MATERIALS AND METHODS: The prospective, noninterventional study was designed to collect information regarding the use of PCMP in a real-world situation. Eligibility included male and female patients aged 18 years and older with target wounds (partial- or full-thickness) suitable for the use of PCMP. Enrolled patients were followed approximately weekly for up to 32 weeks. All wounds and the subgroups were analyzed to determine the frequency and median time to wound closure using Kaplan-Meier methods. RESULTS: The patients with PIs were older adults with a mean age of 69 years and a mean BMI of 27 kg/m2. At baseline, the mean measured wound length was 3 cm, the mean depth was 8.0 mm, the mean volume was 12.6 cm3, and the mean area was 10.5 cm2. Complete wound closures were evident in 5% of patients (n = 2) at week 4, and were achieved in 39% of patients (n = 18) by week 16, in 49% (n = 22) by week 24, and in 62% (n = 28) by week 32. The median time to wound closure was 32 weeks. For all 45 PIs managed with PCMP, the incidence of achieving greater than 60% reduction in baseline area and depth was 78% (n = 35) and 64% (n = 29), respectively, with approximately 82% (n = 37) of wounds showing a reduction in volume greater than 75%. CONCLUSIONS: It appears that PCMP is a useful adjunct in managing chronic deep wounds such as PIs.

Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial.

Objective: High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight i:X can improve identification of wounds with high bacterial burden (>104 colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. Approach: A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). Results: Around 287/350 wounds (82%) had bacterial loads >104 CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>104 CFU/g) by fourfold, and this was consistent across wound types (p < 0.001). Specificity of CSS+FL remained comparably high to CSS (p = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. Innovation: This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. Conclusion: Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.

Management of postoperative bleeding in surgically debrided wounds: topical haemostat versus electrocautery.

OBJECTIVE: To compare the effectiveness of a temporary topical external haemostat (OMNI-STAT Granules, Omni-stat Medical Inc., US) versus the use of electrocautery for bleeding control in patients who have undergone surgical wound debridement. Time saved in the operating room (OR) was evaluated. METHOD: A prospective evaluation of use of a topical haemostat in an OR setting was compared with retrospective data collected using electrocautery to understand the time-saving benefits of using a topical haemostat versus electrocautery. RESULTS: A total of 52 patients were treated with the topical haemostat, and 89 patients with electrocautery. The topical haemostat was shown to be as effective in achieving haemostasis post-surgical debridement as electrocautery, with the added benefits of significant time savings in the OR (reducing the mean total OR time by 19.1%). Additionally, preprocedure and surgical procedure times in patients treated with the topical haemostat were significantly reduced. The results showed that wounds treated with the topical haemostat demonstrated a more advanced stage of healing, which may be a result of the lack of tissue damage demonstrated with the topical haemostat compared with electrocautery. CONCLUSION: This study found that the temporary topical haemostat was equally as effective as cauterisation in achieving haemostasis. In addition, significant saving in OR time was demonstrated relative to electrocautery. The improved OR times may translate into increased cost-effectiveness, relative to electrocautery, by increasing the number of surgical cases per day and/or using resources more effectively to treat more patients. It may also enable bleeding control in the outpatient clinic or at the bedside, freeing up costly OR time and enabling more effective management of healthcare resources.

Hyperbaric oxygen therapy in preventing mechanical ventilation in COVID-19 patients: a retrospective case series.

OBJECTIVE: A pandemic afflicts the entire world. The highly contagious SARS-CoV-2 virus originated in Wuhan, China in late 2019 and rapidly spread across the entire globe. According to the World Health Organization (WHO), the novel Coronavirus (COVID-19)has infected more than two million people worldwide, causing over 160,000 deaths. Patients with COVID-19 disease present with a wide array of symptoms, ranging from mild flu-like complaints to life threatening pulmonary and cardiac complications. Older people and patients with underlying disease have an increased risk of developing severe acute respiratory syndrome (SARS) requiring mechanical ventilation. Once intubated, mortality increases exponentially. A number of pharmacologic regimens, including hydroxychloroquine-azithromycin, antiviral therapy (eg, remdesevir), and anti-IL-6 agents (e.g., toclizumab), have been highlighted by investigators over the course of the pandemic, based on the therapy's potential to interrupt the viral life-cycle of SARS-CoV-2 or preventing cytokine storm. At present, there have been no conclusive series of reproducible randomised clinical trials demonstrating the efficacy of any one drug or therapy for COVID-19. CASES: COVID-19 positive patients (n=5) at a single institution received hyperbaric oxygen therapy (HBOT) between 13 and 20 April 2020. All the patients had tachypnoea and low oxygen saturation despite receiving high FiO2. HBOT was added to prevent the need for mechanical ventilation. A standard dive profile of 2.0ATA for 90 minutes was employed. Patients received between one and six treatments in one of two dedicated monoplace hyperbaric chambers. RESULTS: All the patients recovered without the need for mechanical ventilation. Following HBOT, oxygen saturation increased, tachypnoea resolved and inflammatory markers fell. At the time of writing, three of the five patients have been discharged from the hospital and two remain in stable condition. CONCLUSION: This small sample of patients exhibited dramatic improvement with HBOT. Most importantly, HBOT potentially prevented the need for mechanical ventilation. Larger studies are likely to define the role of HBOT in the treatment of this novel disease.

Effect of Native Type I Collagen with Polyhexamethylene Biguanide Antimicrobial on Wounds: Interim Registry Results.

BACKGROUND: Biofilm can impair wound healing by maintaining an elevated, but ineffective, inflammatory state. This article describes interim results from the prospective RESPOND postmarketing registry evaluating the use of a native type 1, porcine collagen matrix with the embedded antimicrobial polyhexamethylene biguanide (PCMP) in the management of chronic wounds. METHODS: Adults ≥18 years of age with ≥1 appropriate wound were eligible for inclusion. Data that were final on January 26, 2018 were included in this analysis. At week 0, wounds were cleaned, debrided, and prepared as necessary and PCMP was applied, with a dressing to fix it in place. Patients received standard wound care plus PCMP weekly, up to 24 weeks, at the investigator's discretion. At each visit, wounds were assessed for area and quality of granulation tissue. RESULTS: Most common wound types (N = 63) were venous ulcers (28.6%), trauma and lacerations (22.2%), postsurgical open wounds (15.9%), pressure injuries (12.7%), and diabetic ulcers (9.5%). Median baseline wound area was 6.5 cm2; mean wound duration at baseline was 4 months. Of the 63 wounds, 43 (68.3%) achieved complete wound closure, 41 of 43 (95.3%) closed after PCMP treatment, and 2 of 43 (4.7%) after bridging to other modalities and surgical closure. Twelve out of 63 wounds were bridged to other modalities after PCMP treatment. Mean time to closure for PCMP wounds was 5.0 weeks. CONCLUSIONS: PCMP appears to be a useful adjunct for treating various wound types. PCMP use should be considered when managing chronic or acute wounds.

Flow-through Instillation of Hypochlorous Acid in the Treatment of Necrotizing Fasciitis.

INTRODUCTION: Necrotizing fasciitis (NF) is a rare and rapidly progressing bacterial infection of soft tissues. Bacterial toxins cause local tissue damage and necrosis, as well as blunt immune system responses. A self-propagating cycle of bacterial invasion, toxin release and tissue destruction can continue until substantial amounts of tissue become necrotic. Neutralization of bacterial toxins should improve the results. MATERIALS AND METHODS: Pure hypochlorous acid (HOCl) (0.01% w/v) with no sodium hypochlorite impurity in saline pH 4-5, which was recently shown to both eradicate bacteria and neutralize bacterial toxins in vitro, was administered via flowthrough instillation to 6 patients with NF 4-6 times daily as needed. Utilizing a vacuum-assisted closure, 5-10 mL of pure 0.01% HOCl with no sodium hypochlorite impurity was instilled and removed frequently to irrigate the wounds. RESULTS: Of the 6 patients, no deaths or limb amputations occurred. All infected areas healed completely without major complications. CONCLUSION: The toxicity and immune dysfunction caused by bacterial toxins and toxins released from damaged cells may be mitigated by flow-through instillation with saline containing pure 0.01% HOCl with no sodium hypochlorite impurity. Randomized controlled clinical trial research of this relatively simple and inexpensive instillation protocol is suggested for identified cases of NF.

Wound Care Centers: Critical Thinking and Treatment Strategies for Wounds

Many wound care centers (WCCs) provide a specialized level of care using various wound care therapies and are managed by quali ed healthcare professionals (QHPs) from di erent specialty backgrounds such as family medicine, podiatry, and plastic surgery. However, these QHPs are sometimes challenged by reimbursement issues, limited therapy and dressing options, reduced access to multidisciplinary team members, and cost-driven factors unique to WCCs. To help address these issues, a meeting was convened by an expert panel of WCC physicians to discuss best practices for treating complex patients in a WCC. This publication presents an overview of WCC chal- lenges, describes a holistic approach to treating WCC patients, and provides clinical guidance on the decision-mak- ing process for selecting optimal treatment plans for the WCC patient. Clinical cases of atypical, surgical and chronic wounds seen in a WCC are also presented.

Clinical experience using a novel wound management system for venous leg ulcers.

Recent preliminary studies have shown Sepaderm® to be well tolerated and useful for the treatment of chronic, lower-extremity ulcerations, burn wounds, surgical excisions, chronic abdominal ulcers of hematoma origin, and chronic pressure ulcers. To confirm these initial findings, 18 cases of venous leg ulcers were treated with Sepaderm in conjunction with compression bandages. Patients had a mean age of 54.9 ± 13.5 years, and 78.9% were men. Six of the patients had previous standard treatments and 12 patients had Sepaderm as their initial treatment. Treatment duration with Sepaderm ranged from 6 to 90 days with a mean of 44.3 ± 25 days. The system was changed every 3 to 8 days depending on the amount of exudate. All the wounds responded positively with either partial or complete closure during treatment. Importantly, no patient experienced pain during the treatment. These findings suggest that Sepaderm may be effective for the treatment of venous leg ulcers.

Sepaderm for the management of acute and chronic wounds.

The following case series includes a surgical excision, a burn wound, and a chronic venous ulcer that were successfully treated with Sepaderm®, a new wound management system. Sepaderm was chosen for its ease of use and its ability to remove excess exudate from the wound bed. The system also limits exudate leakage onto periwound tissue and protects against direct contact with the wound bed. These cases provide initial evidence that the Sepaderm system performed well and facilitated healing of different wound types, including a previously nonhealing venous leg ulcer. .

Intraoperative hemostasis during spinal reconstructive procedures.

In a consecutive sample of patients undergoing similar spinal reconstructive procedures in the thoracolumbar region, hemostatic effectiveness of a collagen-based composite (CoStasis; Cohesion Technologies, Palo Alto, Calif) n = 10) was compared with standard hemostatic methods (manual compression) (n = 9). All patients treated with CoStasis at the operative site(s) demonstrated immediate hemostasis,whereas all cases treated with gauze and sponges showed protracted bleeding (P < .01). The average perioperative blood loss was approximately twice as great among control patients compared to CoStasis patients (1322 mL versus 685 mL; P = .02). Total transfusion requirements and operative duration also were less among CoStasis patients. These findings suggest CoStasis may provide effective hemostasis in spinal reconstructive procedures such as instrumented fusion where blood loss is excessive.