Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial.

OBJECTIVE: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population. METHOD: Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier analysis was used to determine median time to complete wound closure (CWC). RESULTS: The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to 'not achieved' in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04). CONCLUSION: In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population. DECLARATION OF INTEREST: This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare.

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.

Use of hypothermically stored amniotic membrane on diabetic foot ulcers: a multicentre retrospective case series.

OBJECTIVE: The aim of this retrospective case series was to report on the outcomes of diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM). METHOD: Deidentified case data of patients who received HSAM were obtained from wound care sites across the US. Data were collected, beginning at the first patient visit to the wound care site (first presentation), at the visit in which the first HSAM application occurred (baseline), and at each subsequent visit over 12 weeks of treatment (follow-up). All patients received standard of care (SoC) between first presentation and baseline. RESULTS: Of the 50 patients in the study, 68% were male. Mean age of the entire cohort was 66.7 years. Of the DFUs, 88% were present for <6 months at first presentation. Mean wound area was 3.5cm2, and mean percentage area reduction was -68.3% from first presentation to baseline. The mean number of HSAM applications was 5.5, and mean number of days between applications was 7.5. A >60% area reduction was attained in 96.0% of DFUs, and 78% attained complete wound closure (CWC) by week 12. The median time to CWC was 55 days. CONCLUSION: The results of this retrospective case series suggest positive outcomes for DFUs managed with HSAM. A reduction in time to CWC may lead to lesser financial burden and improved quality of life for DFU patients. DECLARATION OF INTEREST: The authors have no conflicts of interest.