MedTrace Logo

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

NCT04545476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-05-12

Study results available
· View outcomes & findings →

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

  • Wound Heal

Interventions

DEVICE

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

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.

DEVICE

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

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.

OTHER

Standard Secondary Intention Healing on the Head

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.

OTHER

Standard Secondary Intention Healing on the Lower Extremities

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Anna S Clayton, MD · Vanderbilt University Medical Center Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2022-03-08
Completion
2022-03-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545476 on ClinicalTrials.gov