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NCT04545476 · ClinicalTrials.gov registry record · NA
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
A NA study of Wound Heal, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04545476 is a NA study of Wound Heal that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 37 participants, below the 118-participant average among 23 other Wound Heal trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04545476, a NA study of Wound Heal, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to elucidate if a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances secondary intention healing when compared to conventional secondary intention healing for surgical defects after Mohs micrographic surgery on the head and distal lower extremities (below the knee). This novel biomaterial has already been FDA cleared for surgical wounds.
Conditions Studied
Interventions
- DEVICE Participants in this group will receive the experimental APIS Biomaterial on the Head.
- DEVICE Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.
- OTHER Standard Secondary Intention Healing on the Head
- OTHER Standard Secondary Intention Healing on the Lower Extremities
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2022-03-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545476
The ClinicalTrials.gov registry entry for NCT04545476 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 23 other Wound Heal trials with a reported enrollment target (69% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Wound Heal appearing as the primary indexed condition, and to 4 interventions - of which Participants in this group will receive the experimental APIS Biomaterial on the Head. is the first listed.
NCT04545476 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04545476 about?
NCT04545476 is a clinical study titled "Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities". The purpose of this study is to elucidate if a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances secondary intention healing when compared to conventional secondary intention healing for surgical defects after Mohs micrographic surgery on the head and distal lower extre...
What is the current status of trial NCT04545476?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2020-10-08. Estimated completion is 2022-03-08.
What conditions does trial NCT04545476 study?
This clinical trial studies the following conditions: Wound Heal.
What interventions are being tested in trial NCT04545476?
The interventions under investigation include: Participants in this group will receive the experimental APIS Biomaterial on the Head. (DEVICE), Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities. (DEVICE), Standard Secondary Intention Healing on the Head (OTHER), Standard Secondary Intention Healing on the Lower Extremities (OTHER).
Who is sponsoring clinical trial NCT04545476?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04545476 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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