CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Participants in this group will receive the experimental APIS Biomaterial on the Head. +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04545476
NCT04545476N/ACompleted
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Novel Biomaterial Containing Gelatin, Manuka Honey, and Hydroxyapatite Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities - A Randomized Clinical Trial

Vanderbilt University Medical Center·interventional·Posted Sep 11, 2020·Updated May 12, 2023

In Brief

A clinical study evaluating Participants in this group will receive the experimental APIS Biomaterial on the Head., Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities., and 2 other interventions for Wound Heal. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Heal
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 11, 2020
Enrollment StartOct 8, 2020
Primary CompletionMar 8, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.8 years ago

Interventions

Participants in this group will receive the experimental APIS Biomaterial on the Head.device

One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.device

One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Headother

Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.

Standard Secondary Intention Healing on the Lower Extremitiesother

Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.