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COMPLETED NA

Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities

NCT04545476 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 37 participants
Start Date 2020-10-08
Est. Completion 2022-03-08
Phase NA

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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. It is categorized as NA, 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 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT04545476 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04545476?

This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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