Role of allogeneic placental tissues in penile inversion vaginoplasty.

Background: The role of allogeneic placental tissue (APT) in genital gender-affirming surgery (GAS) is not well understood. Penile inversion vaginoplasty (PIV), the most common genital GAS, often results in tissue healing- or wound-related complications, including scarring and neovaginal stenosis. Surgical reoperation and revision vaginoplasty are common. The aim of this study was to evaluate the contribution of APT to postoperative outcomes in PIV. Methods: The authors performed a retrospective analysis of consecutive adult patients undergoing primary PIV during a 6-year period (September 1, 2014 to September 1, 2020). Subjects receiving intraoperative application of an APT biomaterial were compared to those undergoing primary PIV without APT. Postoperative outcomes-including wound healing morbidity and reoperation-were compared between groups. Short- and long-term complications were classified using Clavien-Dindo. Results: A total of 182 primary PIV cases were reviewed (115 conventional PIV; 67 PIV-APT). The postoperative follow-up time for the population averaged 12.7 months. All-cause and wound related complications were significantly lower amongst PIV-APT patients when compared to conventional PIV (P=0.002 and P=0.004, respectively). The rate of long-term complications was significantly lower in PIV-APT subjects: prolonged pain (P=0.001), prolonged swelling (P=0.047), and neovaginal stenosis (P<0.001). The PIV-APT group required significantly less reoperation for vaginal depth enhancement (P=0.007). Conclusions: Though its use in urogenital reconstruction has been limited, this study indicates that the placement of APT during PIV significantly lowered the risk of complications associated with poor wound healing. This supports a novel use for placental tissues in reducing complications in genital GAS.

Mohs Defect Repair with Dehydrated Human Amnion/Chorion Membrane.

Importance: Reconstructing cosmetically sensitive defects in an aging population undergoing multiple Mohs micrographic surgeries (MMS) may be addressed with alternatives to surgery. Objective: Patients undergoing MMS with defect reconstruction in visually prominent areas receiving placental allograft were compared with traditional autologous tissue-based procedures-flaps and full-thickness skin grafts (FTSG). Design, Setting, and Participants: This retrospective case-control study evaluated patients who underwent MMS for removal of a basal or squamous cell carcinoma with same-day repair. Main Outcomes and Measures: The primary endpoint was the incidence and comparison of postoperative morbidity. Risk for developing medical or cosmetic sequelae was determined through multivariate logistic regression. Results: The study population consisted of 143 propensity score-matched pairs (n = 286) with moderate- to high-risk defects on the face, head, and neck. Compared with autologous tissue, placental allograft cases were associated with significantly lower risk for infection (p = 0.004), poor scar cosmesis (p < 0.0001), scar revision (p < 0.0001), or reoperation (p = 0.0007). Conclusions and Relevance: Postoperative complication rates for placental reconstructions did not exceed those demonstrated by autologous tissue counterparts, indicating this is a safe alternative to flap and FTSG in cosmetically sensitive repairs.

Meshed Split-Thickness Autograft With a Viable Cryopreserved Placental Membrane Overlay for Lower-Extremity Recipient Sites With Increased Risk of Graft Failure.

Introduction: Meshed split-thickness skin grafting represents a rapid and effective technique for surgical wound closure. Factors such as ongoing inflammation, microbial colonization, and a poorly vascularized wound bed increase the rate of skin autograft failure up to 33%. Because of the inherent angiogenic, anti-inflammatory, antimicrobial, and antifibrotic properties of human placental membranes, the complementary use of human placental membranes may promote graft survival and improve success rate for complete ulcer resolution. Methods: In this case series, a viable cryopreserved placental membrane was used as a meshed split-thickness skin grafting overlay in 6 high-risk patients with various comorbidities and recalcitrant nonhealing lower-extremity wounds. Results: The mean size of grafted wounds was 130.3 cm2. The average graft take-rate by postoperative days 10 to 14 was 92.5%, with complete epithelialization of all skin graft interstices observed between days 10 and 21. Transplanted autograft tissues did not lyse or dissolve, and sites remained free of infection and maceration throughout postoperative follow-up. Complete wound closures remained intact at the 12-month follow-up visit. Discussion: Thus far, our clinical experience has warranted the complementary use of viable cryopreserved placental membrane and meshed split-thickness skin grafting to reduce the need for repeat surgical interventions or prolonged local wound care due to graft loss or failure in high-risk patients.

Open Surgical Implantation of a Viable Intact Cryopreserved Human Placental Membrane for the Treatment of Recalcitrant Plantar Fasciitis: Case Report With Greater than 2-Year Follow-Up Duration.

Plantar fasciitis is one of the most common conditions encountered by a podiatric physician. Although most individuals respond well to traditional conservative and surgical remedies, a portion of patients will exhaust all available treatment options and will experience ongoing pain that can ultimately affect their quality of life. There has been an increase in scientific and clinical research surrounding the medical use of human placental membranes (HPMs) and many of these point-of-care allografts are now commercially available. We present the case of a 53-year-old female with chronic plantar fasciitis for whom both conservative therapies and surgical treatments of 1 year's duration had previously failed. After open revision with implantation of viable intact cryopreserved human placental membrane (vCPM; Grafix®, Osiris Therapeutics, Inc., Columbia, MD), the patient was able to resume her full-work duty with minimal symptoms at the 12- and 24-month follow-up examinations. This case report highlights the use of HPMs as an adjunct approach in the treatment of recalcitrant plantar fasciitis and the need for continued research.

Viable placental allograft as a biological dressing in the clinical management of full-thickness thermal occupational burns: Two case reports.

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 1 case was of a man who sustained a 55.4 cm full-thickness 3 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 2 case was of a female who sustained a 4.7 cm full-thickness 3 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.

A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management.

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.

Wound Closure in Smoking Peripheral Arterial Disease Patients With Treatment-Refractory Ulcerations: A 12-Month Follow-up Case Series.

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.

Placental Membranes for Management of Refractory Cutaneous Sinus Tracts of Surgical Origin: A Pilot Study.

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.