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Novel Biomaterial Containing Gelatin, Manuka Honey, and Hydroxyapatite Enhanced Secondary Intention Healing Versus Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities-A Randomized Controlled Trial: Pilot Study.

Authors :
Arnaud K
Wallace MM
Wheless LE
Stebbins WG
Clayton AS
Source :
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2023 Dec 01; Vol. 49 (12), pp. 1160-1164. Date of Electronic Publication: 2023 Aug 30.
Publication Year :
2023

Abstract

Background: Randomized, comparative studies evaluating augmented secondary intention healing (SIH) compared with conventional SIH in dermatologic surgery are limited. This study aimed to evaluate whether the use of a novel biomaterial enhances SIH, particularly in shortening time to complete re-epithelialization.<br />Objective: The purpose of this study was to elucidate whether a novel biomaterial containing gelatin, manuka honey, and hydroxyapatite enhances SIH when compared with conventional SIH for surgical defects after Mohs micrographic surgery (MMS) on the head and distal lower extremities.<br />Materials and Methods: Thirty-seven patients were enrolled in this randomized controlled trial. Patients undergoing MMS on the head or distal lower extremities were eligible for recruitment. After clear surgical margins were obtained post-MMS, patients were randomized to receive standard SIH or biomaterial enhanced SIH. Patients had regularly scheduled follow-ups with questionnaires at each visit until complete re-epithelialization was achieved.<br />Results: Overall, there was no significant difference in time to re-epithelialization between standard SIH and biomaterial-enhanced SIH. However, there was a significant decrease in pain scores and skin thickness in the biomaterial-enhanced SIH group.<br />Conclusion: Biomaterial-enhanced SIH is noninferior to standard SIH and produces less pain and favorable skin thickness compared with standard SIH. ClinicalTrials.gov listing: NCT04545476.<br /> (Copyright © 2023 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Details

Language :
English
ISSN :
1524-4725
Volume :
49
Issue :
12
Database :
MEDLINE
Journal :
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
Publication Type :
Academic Journal
Accession number :
37647156
Full Text :
https://doi.org/10.1097/DSS.0000000000003924