Trial reportInternational wound journal2018
A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix
Trial report in International wound journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06831760 (A Randomized, Controlled Clinical Trial Evaluating the Efficacy of Type-I Collagen-based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers), which is not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Controlled Clinical Trial Evaluating the Efficacy of Type-I Collagen-based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers
Who cites it
39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- Assessing the Outcomes and Complications of Skin Allografts in Healing Diabetic Foot and Venous Leg Ulcers: A Systematic Review of Randomised Controlled Trials.International wound journal · 2026Pooled it
- Compression Stockings for the Prevention of Venous Leg Ulcer Recurrence: A Health Technology Assessment.Ontario health technology assessment series · 2019Pooled it
- Dressings and topical agents for treating venous leg ulcers.The Cochrane database of systematic reviews · 2018Pooled it
- Assessing the Safety, Tolerability and Efficacy of Cell-Free Amniotic Fluid in the Treatment of Non-Healing Venous Ulcers: Initial Experience From a Prospective, Multicenter, Phase II Study.International wound journal · 2025Trial
- Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft.International wound journal · 2019Trial
- Clinical outcomes and prognostic determinants of dehydrated human amnion/chorion membrane for refractory venous leg ulcers.Journal of vascular surgery. Venous and lymphatic disorders · 2026Article
- Effect of platelet-rich fibrin gel combined with alginate dressing on healing of active venous leg ulcers: a randomized clinical trial.Frontiers in medicine · 2026Article
- A retrospective real-world analysis of placental-based allografts on pressure ulcers.SAGE open medicine · 2026Article
- Real-World Use of a Decellularized Porcine Placental Extracellular Matrix in Hard-to-Heal Wounds: A Retrospective, Single-Center Study.Journal of clinical medicine · 2025Article
- Amniotic Membrane Transplantation for Wound Healing, Tissue Regeneration and Immune Modulation.Stem cell reviews and reports · 2025Review
- A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers.Health science reports · 2025Article
- Comparative Study of Placental Allografts with Distinct Layer Composition.International journal of molecular sciences · 2025Article
- PURIONJournal of biomaterials applications · 2024Article
- Review
- Amnion-derived hydrogels as a versatile platform for regenerative therapy: from lab to market.Frontiers in bioengineering and biotechnology · 2024Review
- Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products.Advanced healthcare materials · 2023Review
- Clinical Efficacy of Hyaluronic Acid with Iodine in Hard-to-Heal Wounds.Pharmaceutics · 2023Article
- Placental-Derived Biomaterials and Their Application to Wound Healing: A Review.Bioengineering (Basel, Switzerland) · 2023Review
- Skin substitutes as treatment for chronic wounds: current and future directions.Frontiers in medicine · 2023Review
- Functionalised-biomatrix for wound healing and cutaneous regeneration: future impactful medical products in clinical translation and precision medicine.Frontiers in bioengineering and biotechnology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non-healing full-thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log-rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25-4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non-healing, full-thickness venous leg ulcers.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.