Effectiveness of a purified type I collagen matrix plus the antimicrobial polyhexamethylene biguanide for use in cutaneous wounds: analysis of a population of three combined registries.

INTRODUCTION: Chronic wounds represent a significant burden to the health care system and patients. OBJECTIVE: This study determined the effectiveness of a wound scaffold comprised of PCMP for use in nonhealing, cutaneous wounds; this study analyzes pooled data from the population of 3 combined registries. MATERIALS AND METHODS: A total of 3 combined registry populations were pooled from a single-center study of 41 patients, a single-center study of 86 patients, and the RESPOND Registry of 307 patients treated at 28 centers. All 434 patients received PCMP and were followed for up to 48 weeks. Male and female patients 18 years or older with wounds between 0.2 cm2 and 200 cm2 were included. RESULTS: In total, there were 95 VLUs, 78 DFUs, 90 PIs, 73 PSWs, and 98 wounds of other etiologies analyzed. The mean baseline area, depth, and volume of all 434 wounds was 15.1 cm2, 4.9 mm, and 7.2 cm3, respectively. K-M median time to wound closure for all wounds was 19 weeks. At weeks 20, 24, 28, and 48, the frequency of wound closure for all wounds was 51%, 56%, 62%, and 72%, respectively. The median time to closure by wound type was 22 weeks for VLUs, 24 weeks for DFUs, 23 weeks for PIs, 12 weeks for PSWs, and 14 weeks for other wounds. The proportion of wounds closed were 72% (VLUs), 52% (DFUs), 63% (PIs), 95% (PSWs), and 67% (other etiologies). CONCLUSIONS: This 434-patient PCMP cohort analysis showed 72% wound closure and median time to wound closure of 19 weeks. PCMP demonstrated effectiveness for use in multiple wound types.

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.

Type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of cutaneous wounds.

Aim: Determine the effectiveness of purified native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) on cutaneous wounds. Materials & methods: A prospective cohort study of 307 patients (67 venous leg ulcers, 62 diabetic foot ulcers, 45 pressure ulcers, 54 post-surgical wounds and 79 other wounds) was conducted. Results: Cox wound closure for PCMP was 73% at week 32. The median time to wound closure was 17 weeks (Kaplan-Meier). The incidence of PCMP-treated wounds showing >60% reductions in areas, depths and volumes were 81, 71 and 85%, respectively. Conclusion: PCMP demonstrated clinically meaningful benefits to patients with various types of cutaneous wounds. Clinical Trial registration number: NCT03286452.

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.

Management of a Complex Excoriation Disorder-induced Wound with a Viable Cryopreserved Placental Membrane.

Excoriation disorder (ED), also known as dermatotillomania, is a condition characterized by repeated "skin picking" that leads to the formation of skin lesions. Because of the similarity of its symptoms to obsessive compulsive disorder, ED is classified as a subcategory of obsessive compulsive disorder by Diagnostic and Statistical Manual of Mental Disorders Fifth Edition. Although the majority of the self-inflicted wounds are not clinically significant, many wounds lead to social and occupational dysfunction by becoming infected, chronic, and life threatening. This report describes the successful use of a viable intact cryopreserved human amniotic membrane in conjunction with selective serotonin re-uptake inhibitors in treating an ED patient who presented with a large calvarial wound of 3-year duration that had failed previous extensive medical and surgical interventions.

The reliability of digital imaging in the remote assessment of wounds: defining a standard.

CONTEXT: Telemedicine has been used for remote management of many medical problems. Given the ever-expanding demands to provide increasing service with increasingly limited resources, quality care and practice efficiency can be enhanced by telemedicine. OBJECTIVE: This study was undertaken to explore the reliability of wound assessment using computer-transmitted digital imagery compared with a traditional bedside evaluation and also to assess its potential role in healthcare delivery. DESIGN/SETTING/PATIENTS: In the hospital setting, rounding vascular surgeons and a surgical resident evaluated the wounds on the service. A digital photograph was obtained with a 3.3 megapixel camera, and a wound-assessment tool was completed. A plastic surgery attending then reviewed the images at a later date and completed the same data tool. MAIN OUTCOME MEASURES: Wounds were rated for eschar, exposed bone, cellulitis, purulence, swelling, granulation tissue, granulation color, and depth using a standardized data collection tool. kappa statistics were computed for all variables, between raters. RESULTS: There were 2 phases of the study. In both phases, there was 100% agreement by the rounding physicians that the digital image was representative of the wound. Phase 1 agreement between evaluators was moderate to almost perfect, as demonstrated by kappa values (range, 0.50-0.87). In phase 2, all variable kappa values were rated as almost perfect, except the ability to evaluate depth of the wound to the millimeter, which was rated as substantial. CONCLUSIONS: The ability to accurately evaluate a wound on the basis of a digital image is possible. However, it requires training of participants and is facilitated by use of an assessment tool. With these caveats, evaluation of wounds using digital images is equivalent to bedside examination. This technology can improve practice efficiency, provide needed expertise at remote sites, and is an acceptable alternative method of wound assessment.

Activation of macrophage promatrix metalloproteinase-9 by lipopolysaccharide-associated proteinases.

LPS induces an up-regulation of promatrix metalloproteinase-9 (proMMP9) gene expression in cells of the monocyte/macrophage lineage. We demonstrate here that LPS preparations are also able to activate proMMP9 made by human macrophages or THP-1 cells via LPS-associated proteinases, which cleave the N-terminal propeptide at a site or sites close to the one cleaved upon activation with organomercurial compounds. LPS-associated proteinases are serine proteinases that are able to cleave denatured collagens (gelatin) and the mammalian serine proteinase inhibitor, alpha(1)-proteinase inhibitor, thereby pushing the balance of extracellular matrix turnover even further toward degradation. A low molecular mass, low affinity inhibitor of MMP9, possibly derived from the propeptide, is generated during proMMP9 activation. However, inhibition of the LPS-associated proteinases had no effect on proMMP9 synthesis, indicating that their proteolytic activity was not required for signaling the up-regulation of the proMMP9 gene.