Advances in tissue preservation have led to the commercialization of human placental membranes for the purposes of wound management with each product being characterized by different compositions and properties. The a priori specification of the research question in this investigator‐initiated study focused on the clinical outcomes in two nonrandomized, however statistically equal and homogenous patient cohorts receiving either a viable intact cryopreserved human placental membrane (vCPM) or a dehydrated human amnion/chorion membrane (dHACM), for the management of wounds at a single center. A total of 79 patients with 101 wounds were analyzed: 40 patients with 46 wounds received vCPM and 39 patients with 55 wounds received dHACM. The proportion of wounds achieving complete wound closure was 63.0% (29/46) for vCPM and 18.2% (10/55) for dHACM (p < 0.0001) for all treated wounds combined. This is the first comparative effectiveness study to report on the clinical outcomes associated with the use of different placental wound care products once broadly implemented in the clinical setting.

Despite ongoing smoking cessation efforts and optimized perfusion, failed wound closure in the presence of peripheral arterial disease (PAD) and diabetes are common. A clinical effectiveness review was conducted in actively smoking diabetic patients diagnosed with PAD, treated with serial applications of a viable intact cryopreserved human placental membrane (vCPM) (Grafix, Osiris Therapeutics Inc, Columbia, MD) for recalcitrant lower extremity ulcerations (n = 6). More than half of the patients were not candidates for revascularization. Baseline vascular status in 5 of 6 lower-extremity wounds remained unchanged throughout the entire course of vCPM treatment. Daily cigarette consumption averaged 18 cigarettes per patient. Mean wound duration and mean surface area was 53 weeks and 4.6 cm2, respectively. Mean number of vCPM applications and time to closure was 7.0 grafts in 7.8 weeks. There were no wound-related infections or amputations and no vCPM-related adverse events. All 6 wounds remained closed at the 12-month follow-up visit. In conclusion, vCPM demonstrated clinically effective outcomes in 6 previously nonhealing ulcerations despite ongoing smoking habits in the presence of PAD and diabetes.

Despite advances in surgical technique, postoperative complications may lead to refractory cutaneous sinus tracts or tunnels. Negative pressure wound therapy is difficult to apply in longer tracts with a narrow diameter opening and conservative treatment failures ultimately necessitate surgical revisions. The aim of this pilot study was a clinical utility assessment of two different commercial placental membrane products for refractory cutaneous sinus tracts of surgical origin. Patients were treated with viable cryopreserved placental membrane (vCPM, n = 6) or devitalized dehydrated amnion/chorion membrane (dHACM, n = 6). The primary outcome measurement was the proportion of complete sinus tract depth resolution without exudate. Secondary endpoints included 4-week percent reduction in sinus tract probing depth and peri-tract wound surface area, days and number of grafts to resolution, number of wound-related infections, and 1-year recurrence rate for closed sinus tracts. All vCPM patients demonstrated complete sinus tract resolution compared to zero closures in the dHACM group (p = 0.00216). The vCPM group achieved greater percent reduction in probing depth (73.3 ± 21.9 versus −4.4 ± 91.3) and surrounding wound surface area (34.8 ± 86.8 versus −279.3 ± 454.9) at 4 weeks than dHACM. The use of viable intact cryopreserved placental membrane has demonstrated positive clinical outcomes for the treatment for refractory exudative sinus tracts and may be an alternative to repeat surgical intervention.