Comparative effectiveness of a bilayered living cellular construct and a porcine collagen wound dressing in the treatment of venous leg ulcers

Using data from a national wound-specific electronic medical record (WoundExpert, Net Health, Pittsburgh, PA), we compared the effectiveness of a bilayered living cellular construct (BLCC) and an acellular porcine small intestine submucosa collagen dressing (SIS) for the treatment of venous leg ulcer. Data from 1,489 patients with 1,801 refractory venous leg ulcers (as defined by failure to have >40% reduction in size in the 4 weeks prior to treatment) with surface areas between 1 and 150 cm2 in size, treated between July 2009 and July 2012 at 158 wound care facilities across the US were analyzed. Patient baseline demographics and wound characteristics were comparable between groups. Kaplan-Meier–derived estimates of wound closure for BLCC (1,451 wounds) was significantly greater (p = 0.01, log-rank test) by weeks 12 (31% vs. 26%), 24 (50% vs. 41%), and 36 (61% vs. 46%), respectively, compared with SIS (350 wounds). BLCC treatment reduced the median time to wound closure by 44%, achieving healing 19 weeks sooner (24 vs. 43 weeks, p = 0.01, log-rank test). Treatment with BLCC increased the probability of healing by 29% compared with porcine SIS dressing (hazard ratio = 1.29 [95% confidence interval 1.06, 1.56], p = 0.01)

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 postsurgical 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 \u3e60% 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

Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting

We evaluated the comparative effectiveness of a bioengineered living cellular construct (BLCC) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of diabetic foot ulcers (DFUs). Using a wound care-specific electronic medical record database, we assessed real-world outcomes in 218 patients with 226 DFUs receiving treatment in 2014 at 99 wound care centers. The analysis included DFUs ≥1 and <25 cm2 with duration <=1 year and area reduction ≤20% in 14 days prior to treatment (N=163, BLCC; N=63, dHACM). The average baseline areas and durations were 6.0 cm2 and 4.4 months for BLCC and 5.2 cm2 and 4.6 months for dHACM, respectively. Patients treated with dHACM had more applications compared to those treated with BLCC (median 3.0 vs. 2.0) (p=0.003). A Cox model adjusted for key covariates including area and duration found the median time to closure for BLCC was 13.3 weeks compared to 26 weeks for dHACM, and the proportion of wounds healed were significantly higher for BLCC by 12 weeks (48% vs. 28%) and 24 weeks (72% vs. 47%) (p=0.01). Treatment with a bioengineered living cellular technology increased the probability of healing by 97% compared with a dehydrated amniotic membrane (hazard ratio = 1.97 [95% confidence interval 1.17, 3.33], p=0.01)

Behavior of Tissue-Engineered Skin: A Comparison of a Living Skin Equivalent, Autograft, and Occlusive Dressing in Human Donor Sites

OBJECTIVE To compare the behavior of a tissue-engineered living skin equivalent (LSE) with an autograft in acute donor site wounds. DESIGN Paired-comparison, randomized control trial. SETTING A university dermatology service. PATIENTS Three donor sites were created on the anterior thigh of each of 20 patients requiring split-thickness skin grafts. INTERVENTION For each patient, the donor sites were randomly assigned to be treated with meshed LSE, meshed autograft, or a polyurethane film (PUF) occlusive dressing. Blood and biopsy samples were taken for immunologic and histological studies. MAIN OUTCOME MEASURES Toxic effects or clinically apparent rejection, humoral and cellular immune responses, clinical take, healing time, pain, and 1-month histological appearance. RESULTS There was no toxic effect or clinically apparent rejection of LSE. Results of humoral and cellular studies were unchanged from baseline. The average time to healing for LSE with clinical take was 7.3 days (SD,±0.8 days); for autograft, 7.6 days (SD,±1.1 days); and for PUF, 9.5 days (SD,±1.8 days). The difference between LSE or autograft and PUF was statistically significant at the .001 level. Pain was experienced by 1 patient, no patients, and 10 patients at the LSE, autograft, and PUF sites, respectively. Histologically, LSE had the thickest epidermis (P=.02), PUF had the greatest degree of fibrosis (P=.02), and autograft had the least degree of increased inflammation (P=.004) and vascularity (P=.01). CONCLUSIONS In acute donor site wounds, LSE appeared to clinically take and to be a safe and usable form of tissue therapy.Arch Dermatol. 1999;135:913-918--