CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 7 enrolled
Drug / intervention
Amnion Membrane Powder +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03754218
NCT03754218Early Ph 1Completed
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Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing

Wake Forest University Health Sciences·interventional·Posted Nov 27, 2018·Updated Jan 9, 2024

In Brief

A Early Phase 1 clinical trial evaluating Amnion Membrane Powder and SOC Wound Covering for Burns and 2 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed Summary

The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns, Wound of Skin, Skin Wound
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedNov 27, 2018
Enrollment StartDec 1, 2019
Primary CompletionNov 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.6 years ago

Interventions

Amnion Membrane Powderdrug

This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.

SOC Wound Coveringprocedure

Institutional standard of care wound covering.