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NCT03754218 · ClinicalTrials.gov registry record · Early Phase 1
Amnion Wound Covering for Enhanced Wound Healing
A Early Phase 1 study of Burns and Wound of Skin, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT03754218: Completed Early Phase 1 study of Burns and Wound of Skin, sponsored by Wake Forest University Health Sciences.
NCT03754218 is a Early Phase 1 study of Burns and Wound of Skin that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 7 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03754218, a Early Phase 1 study of Burns and Wound of Skin, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Wound closure for both amnion membrane product and SOC will be defined as skin re-epithelization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Conditions Studied
Interventions
- DRUG Amnion Membrane Powder
- PROCEDURE SOC Wound Covering
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2023-11-22 |
| Phase | Early Phase 1 |
What the finished NCT03754218 record still lists
NCT03754218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 83-participant average among 36 other Burns trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions - of which Amnion Membrane Powder is the first listed.
NCT03754218 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03754218 about?
NCT03754218 is a clinical study titled "Amnion Wound Covering for Enhanced Wound Healing". 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 bac...
What is the current status of trial NCT03754218?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2019-12-01. Estimated completion is 2023-11-22.
What conditions does trial NCT03754218 study?
This clinical trial studies the following conditions: Burns, Wound of Skin, Skin Wound.
What interventions are being tested in trial NCT03754218?
The interventions under investigation include: Amnion Membrane Powder (DRUG), SOC Wound Covering (PROCEDURE).
Who is sponsoring clinical trial NCT03754218?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03754218 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Burns
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03754218's enrollment target sits among peer trials
7 34th of 36 higher than 2 of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
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Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
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Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
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Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
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Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
RECRUITING · Phase 2
-
Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
RECRUITING · NA
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