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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: Completed NA study of Wound Heal, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete wound re-epithelialization is defined by epidermal regrowth covering entire post-operative defect. Patients will be seen in office 14 days post-operative, then every 14 days thereafter until complete re-epithelialization is achieved. Patients will also submit photos via Vanderbilt HIPAA compliant Box at regular follow-up intervals (post-operative day 7 then every 14 days thereafter until complete re-epithelialization is achieved). Time elapsed from surgery date to complete re-epithelial
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 |
What the finished NCT04545476 record still lists
NCT04545476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 118-participant average among 23 other Wound Heal trials with a reported enrollment target (69% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT04545476's enrollment target sits among peer trials
37 18th of 23 higher than 5 of 23 other Wound Heal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wound Heal 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
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