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COMPLETED Early Phase 1

Amnion Wound Covering for Enhanced Wound Healing

NCT03754218 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Amnion Membrane Powder
  • PROCEDURE SOC Wound Covering

Study Locations (1)

North Carolina

  • Wake Forest University Health Sciences — Winston-Salem

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2019-12-01
Est. Completion 2023-11-22
Phase Early Phase 1

Sponsor

Wake Forest University Health Sciences

1,061 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03754218

The ClinicalTrials.gov registry entry for NCT03754218 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03754218 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03754218?

The interventions under investigation include: Amnion Membrane Powder (DRUG), SOC Wound Covering (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03754218?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial