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.
Kazu Suzuki, DPM, CWS is a member of the Speakers' Bureau at Osiris Therapeutics Inc., Georgina Michael and Yeabsera Tamire belong to the Department of Medical Affairs at Osiris Therapeutics Inc.
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.
BackgroundThe purpose of this study is to report on the rehabilitative outcomes associated with common peroneal nerve (CPN) decompression and neurolysis revision when performed with open surgical implantation of a viable cryopreserved placental membrane (vCPM).MethodsSeven patients who underwent secondary CPN decompression and neurolysis with open surgical implantation of a viable cryopreserved placental membrane (vCPM) after previously failed surgery without vCPM utilization were identified through a retrospective medical record review and outcomes were analyzed. Primary mechanism of injury, severity of symptoms at time of referral, pre-operative and post-operative evaluations on edema with ultrasound, Medical Research Council (MRC) scale for motor strength, range of motion, nerve conduction velocity (NCV), and electromyography (EMG) were analyzed.ResultsFive patients (71.4%) achieved full recovery of motor function MRC grade 5/5, and the remaining two patients achieved MRC grade 4/5. At the 7-month follow-up visit, NCV tests indicated improved conduction velocity and normal amplitude for all 7 patients, and all patients demonstrated proper gait pattern with a return to normal activities of daily living. There were no vCPM-related adverse events.ConclusionsThe use of vCPM wrap as an adjunct to surgical repairs of CPN injuries may contribute to positive clinical outcomes.
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