N/A
N=37
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
Wound Heal
Bottom Line
View on ClinicalTrials.gov: NCT04545476 ↗Enrolled (actual)
37
Serious AEs
—
Results posted
May 2023
Primary outcome: Primary: Time to Complete Wound Re-epithelialization on the Head — 41.6; 43 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Wound Re-epithelialization on the Head |
41.6; 43 | — |
| PRIMARY Time to Complete Wound Re-epithelialization on the Lower Extremities |
49.5; 52.7 | — |
| SECONDARY Patient Self Reported Pain Score |
1.25; 2.62; 1.14; 1.29 | — |
| SECONDARY Number of Participants With at Least One Post-Operative Wound Infection |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With at Least One Report of Post-operative Bleeding |
1; 2; 0; 0 | — |
| SECONDARY Skin Thickness |
2.38; 6.5; 4.43; 3.29 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Post-operative wounds following Mohs surgery on the head or distal lower extremities
- Single Mohs post-operative defect
- Post-operative wounds greater than 1cm in width
- Depth of defect at least to subcutaneous tissue
- Patients have the ability to provide their own wound care
- Agreeable to regularly scheduled follow-up visits and transmission of photos via HIPAA compliant Vanderbilt University Medical Center Box
- Patients are able to provide informed consent
Exclusion Criteria
- Under 18 years of age
- Unable to provide informed consent
- Unable to understand oral and written English
- Post-operative wounds not appropriate for secondary intention healing
- Sensitivity or allergy to APIS® biomaterial including collagen and its derivatives, porcine-derived materials or honey
- Immunosuppressed and organ transplant patients
- Post-operative wounds superficial to subcutaneous tissue
Data sourced from ClinicalTrials.gov (NCT04545476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.