A Prospective Multicenter Randomized Controlled Trial to Evaluate the Efficacy of Chitosan Hydrogel Paste in Comparison to Commercial Hydroactive Gel as a Wound Bed Preparation

Nasir NAM 1 , Saad AZM 1 , Bachok NS 2 , Rashid AHA 3 , Ujang Z 3 , Noorsal K 3 Show all authors , Yusof N 4 , Hashim K 4 , Nor FM 5 , Imran FH 6 , Yusof NM 7 , Sharifudin MA 8 , Halim AS 1

Affiliations 

  • 1 Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia
  • 2 Biostatistic and Research Methodology Unit, School of Medical Sciences, Universiti Sains Malaysia, Kelantan Malaysia
  • 3 SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
  • 4 Nuclear Malaysia Agency, Kajang, Selangor, Malaysia
  • 5 Plastic and Reconstructive Surgery, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpu, Malaysia
  • 6 Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia
  • 7 Orthopaedic Department, Kuliyyah of Medicine, International Islamic University Malaysia, Kuantan, Pahang, Malaysia
  • 8 Faculty of Medicine, Universiti Sultan Zainal Abidin, Kuala Terengganu
Indian J Plast Surg, 2023 Feb;56(1):44-52.
PMID: 36998939 DOI: 10.1055/s-0042-1759503

Abstract

Background  This clinical trial aimed to evaluate the clinical efficacy of chitosan derivative hydrogel paste (CDHP) as a wound bed preparation for wounds with cavities. Methods  This study enrolled 287 patients, with 143 patients randomized into the CDHP group (treatment) and 144 patients randomized into the commercial hydroactive gel (CHG) group (control). The granulation tissue, necrotic tissue, patient comfort, clinical signs, symptoms, and patient convenience during the application and removal of the dressing were assessed. Results  The study was completed by 111 and 105 patients from the treatment and control groups, respectively. Both groups showed an increasing mean percentage of wound granulation over time when the initial wound size and comorbidity were adjusted (F(10,198) = 4.61; p  

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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