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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.

Objective: To evaluate the clinical outcomes of lyopreserved placental membrane containing viable cells (vLPM) in the treatment of nonhealing wounds of various etiologies, and to compare them to those previously reported for cryopreserved placental membrane containing viable cells (vCPM). Approach: Patients with nonhealing wounds who qualified to receive advanced wound therapies were consecutively enrolled and treated weekly with vLPM plus standard of care (SOC) at five centers. Data were de-identified and retrospectively analyzed. Outcomes included closure, time to closure, number of vLPM applications, and adverse events (AEs). Results: Seventy-eight patients with 98 wounds (41 diabetic foot ulcers [DFUs], 19 venous leg ulcers [VLUs], 10 surgical, and 28 others) with an average size of 13.3 cm 2 and 8.7 months duration were treated. Fifty-eight of the 98 wounds (59.2%) achieved complete closure with median time to closure of 63 days and 6 vLPM applications. The closure by wound etiology was 63% for DFUs, 47% for VLUs, 70% for surgical wounds, and 57% for other types of wounds. Similar closure rates have been previously demonstrated for vCPM. Wound duration was the main predictor of closure: 65.8% versus 30.0% (p = 0.004) closure was achieved for wounds of £12 and >12 months duration, respectively. There were no AEs related to vLPM application. Innovation: This is the first multicenter case series evaluating the clinical outcomes of vLPM in a real-world setting. Conclusion: These results support clinical equivalency between the two placental membrane formulations with the added convenience of room-temperature storage for vLPM, allowing it to be used in any wound-care setting.

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.

Rationale:Occupational burn injuries can be detrimental and difficult to manage. The majority of complex cases are referred and managed at regional burn centers where access to specialized care is available. As an alternative to hospitalization with staged surgical procedures, placental products may be used for outpatient medical management of these common burn injuries, especially if access to a regional burn center is limited or restricted.Fresh amnion has been a treatment of choice in burns for more than 100 years. As a biological covering with a broad scope of potential uses, human placental membranes represent a dressing that is particularly advantageous for burn therapy. Recent advances in tissue-preservation technology have allowed for the commercialization of placental amnion products.Patient concerns:To address several complications associated with burn injuries—contractures, scar formation, and pain—a viable cryopreserved placental membrane (vCPM) (Grafix—PRIME, Osiris Therapeutics, Inc., MD) retaining the anti-inflammatory, anti-fibrotic, and antimicrobial properties of fresh placental tissues was chosen for clinical use in the 2 cases reported, where both patients had restricted access to the regional burn center.Diagnoses:Two cases of work-related extremity burns presented to a local rural hospital for immediate post-injury assessment. The 1st case was of a man who sustained a 55.4 cm2 full-thickness 3rd degree thermal burn with exposed bone and tendon, to the left dorsal forefoot after having an industrial pressure washer caught on his work boot. The 2nd case was of a female who sustained a 4.7 cm2 full-thickness 3rd degree crush burn to the dorsum extensor surface of her dominant hand's index finger after applying 80-pounds per square inch of heated pressure from a hydraulic press.Interventions:Both burn patients elected to continue their care at the outpatient-based wound and hyperbaric center, receiving a combination of weekly ad libitum debridement, applications of vCPM, and occupational therapy.Outcomes:Both burns reached timely wound closure, and patients regained full range of motion of the affected limb, allowing for early return to work. The average number of allograft applications was 7.5, allowing both patients to return to work in an average of 63.5 days without adverse events or post-treatment complications.Lessons:The incorporation of this product in the treatment of these complex burns prevented amputation in one patient, and skin autografting and potential index finger contracture-formation in the second patient. The incorporation of vCPM in burn management may offer a new approach to outpatient burn management and may mitigate several of the complications seen post burn injury, leading to favorable patient outcomes.