Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings

Daniel S Rouhani; Navin K Singh; James J Chao; Adah Almutairi; Mehran H Seradj; Rebecca Badowski-Platz; Jason D Toranto; M Mark Mofid

doi:10.1097/PRS.0000000000011316

Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings

Plast Reconstr Surg. 2024 Feb 7. doi: 10.1097/PRS.0000000000011316. Online ahead of print.

Authors

Daniel S Rouhani¹, Navin K Singh², James J Chao³, Adah Almutairi⁴, Mehran H Seradj⁵, Rebecca Badowski-Platz⁶, Jason D Toranto⁷, M Mark Mofid⁸

Affiliations

¹ Daniel S. Rouhani is a Clinical Researcher at the Johns Hopkins University School of Medicine in Baltimore, MD, USA.
² Dr. Navin K. Singh is an Assistant Professor of Plastic Surgery and Neurosurgery at the Johns Hopkins University School of Medicine and is in private practice in McLean, VA, USA.
³ Dr. James J. Chao is in private practice in La Jolla, CA, USA and is Professor Emeritus of Plastic Surgery at the University of California, San Diego, CA, USA.
⁴ Dr. Adah Almutairi is a Professor of Pharmaceutical Chemistry, Materials Science & Engineering and Nanoengineering at the University of California, San Diego, CA, USA.
⁵ Dr. Mehran H. Seradj is an Adjunct Assistant Professor of Dermatology at Shahed University, Tehran, Iran.
⁶ Rebecca Badowski-Platz is the clinical trial manager for San Diego Skin, Inc. in La Jolla, CA, USA.
⁷ Dr. Jason D. Toranto is a plastic surgeon in private practice in San Diego, CA.
⁸ Dr. M. Mark Mofid is a Clinical Assistant Professor of Plastic Surgery at the Johns Hopkins University School of Medicine and is in private practice in La Jolla, CA, USA.

PMID: 38330504
DOI: 10.1097/PRS.0000000000011316

Abstract

Background: Silk fibroin is an emerging biomaterial with enhanced properties of cellular regeneration, growth and proliferation. The use of a silk fibroin wound dressing has the potential to decrease the incidence of wound healing complications and to improve patient outcomes compared to synthetic dressing alternatives.

Methods: A prospective, randomized, single-blinded clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on one side of their body and on the contralateral side with 3M Steri-Strips® after undergoing abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data was collected over 5 postoperative visits using photographs and an investigator administered questionnaire to monitor erythema, skin irritation, skin discomfort, the need for pharmaceutical intervention, wound dehiscence and mechanical skin injury. A comprehensive 75 patient statistical analysis was conducted combining the results with a previously published study comparing Dermabond® Prineo® to the silk dressing.

Results: 20.8% (10/48) of patients were assessed by surgeons as having skin erythema (7-10) on the Steri-Strip® control side and 0% (0/48) on the silk dressing side (p=0.002). The frequency of breast triple point separation in 43 cases was 30.2% (13/43) on the Steri-Strip® side and 9.3% (4/43) on the silk side (p=0.012). 75% (36/48) of patients had partial or total detachment of Steri-Strips® while 0% (0/48) had total detachment of the silk dressing and 18.8% (9/48) had partial detachment of the silk dressing within the first two weeks (p<0.001).

Conclusion: A silk fibroin wound dressing significantly reduces the incidence of wound healing complications throughout the postoperative period.Clinical Relevance Statement: The adoption of a silk fibroin wound dressing into clinical practice has the potential to improve patient outcomes, decrease medical adhesive related skin injuries and reduce the rate of wound healing complications.