Advances in the Use of Electrospun Nanofibrous Polymeric Matrix for Dermal Healing at the Donor Site After the Split-Thickness Skin Graft Excision: A Prospective, Randomized, Controlled, Open-Label, Multicenter Study

Author:

Haik Josef1234ORCID,Ullman Yehuda5,Gur Eyal6,Ad-El Dean7,Egozi Dana8,Kruchevsky Dani5,Zissman Sivan6,Biros Erik9ORCID,Nir Rony-Reuven1ORCID,Kornhaber Rachel14ORCID,Cleary Michelle10,Harats Moti123ORCID

Affiliation:

1. Department of Plastic and Reconstructive Surgery, Sheba Medical Center, Ramat-Gan, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Israel

2. Talpiot Leadership Program, Sheba Medical Center, Tel-Hashomer, Israel

3. Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia

4. College of Health and Medicine, University of Tasmania, Sydney, New South Wales, Australia

5. Department of Plastic and Reconstructive Surgery, Rambam Health Care Campus, affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel

6. Department of Plastic and Reconstructive Surgery, Sourasky Medical Center, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Israel

7. Department of Plastic and Reconstructive Surgery, Rabin Medical Center, Petah-Tikva, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Israel

8. Department of Plastic and Reconstructive Surgery, Kaplan Medical Center, Rehovot, Israel

9. College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia

10. School of Nursing, Midwifery and Social Sciences, CQUniversity Australia, Sydney, Australia

Abstract

Abstract Dressings used to manage donor site wounds (DSWs) have up to 40% of patients experiencing complications that may cause suboptimal scarring. We evaluated the efficacy and safety of a portable electrospun nanofibrous matrix that provides contactless management of DSWs compared with standard dressing techniques. This study included adult patients who underwent an excised split-thickness skin graft (STSG) with a DSW area of 10 to 200 cm2. Patients were allocated into two groups; ie, the nanofiber group managed with a nanofibrous polymer-based matrix, and the control group managed using the standard of care such as Jelonet® or Biatain® Ibu dressing. Primary outcomes were postoperative dermal healing efficacy assessed by Draize scores. The time to complete re-epithelialization was also recorded. Secondary outcomes included postoperative adverse events, pain, and infections during the first 21 days and extended 12-month follow-up. The itching and scarring were recorded during the extended follow-up (months 1, 3, 6, 9, and 12) using Numerical-Analogue-Score and Vancouver scores, respectively. The nanofiber and control groups included 21 and 20 patients, respectively. The Draize dermal irritation scores were significantly lower in the nanofiber vs control group (Z = −2.509; P = .028) on the first postoperative day but became similar afterward (Z ≥ −1.62; P ≥ .198). In addition, the average time to re-epithelialization was similar in the nanofiber (17.9 ± 4.4 days) and control group (18.3 ± 4.5 days; Z = −0.299; P = .764), so were postoperative adverse events, pain, and infection incidence, itching and scarring. The safety and efficacy of electrospun nanofibrous matrix are similar to standard wound care allowing its use as an alternative donor site dressing following the STSG excision.

Funder

European Commission H2020 SME

Nanomedic Technologies Ltd

Publisher

Oxford University Press (OUP)

Subject

Rehabilitation,Emergency Medicine,Surgery

Reference32 articles.

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