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CC BY-NC-ND 4.0 · Indian J Plast Surg 2023; 56(01): 044-052
DOI: 10.1055/s-0042-1759503
Original Article

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

Nur Azida Mohd Nasir 
1   Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia
,
Arman Zaharil Mat Saad
1   Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia
2   Reconstructive Sciences Department, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
,
Nor Sa'adah Bachok 
3   Biostatistic and Research Methodology Unit, School of Medical Sciences, Universiti Sains Malaysia, Kelantan Malaysia
,
Ahmad Hazri Ab Rashid
4   SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
,
Zanariah Ujang
4   SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
,
Kartini Noorsal
4   SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
,
Norimah Yusof
5   Nuclear Malaysia Agency, Kajang, Selangor, Malaysia
,
Kamaruddin Hashim
5   Nuclear Malaysia Agency, Kajang, Selangor, Malaysia
,
Fatimah Mohd Nor 
6   Plastic and Reconstructive Surgery, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpu, Malaysia
,
Farrah-Hani Imran 
7   Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia
,
Nazri Mohd Yusof 
8   Orthopaedic Department, Kuliyyah of Medicine, International Islamic University Malaysia, Kuantan, Pahang, Malaysia
,
Mohd Ariff Sharifudin 
9   Faculty of Medicine, Universiti Sultan Zainal Abidin, Kuala Terengganu
,
Ahmad Sukari Halim
1   Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia
2   Reconstructive Sciences Department, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
› Author Affiliations Funding This work was supported by a grant (No.: (304/PPSP/6150110/s105) from the Ministry of Science, Technology and Innovation (MOSTI) of Malaysia combined with SIRIM to support the pilot production of wound management products from water-soluble chitosan derivatives for preclinical and market evaluation. The funding sources played no role in the design, conduct, analysis, interpretation, reporting, writing of the study, or decision to submit for publication.
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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 < 0.001), but no significant difference was found between the groups (F(1,207) = 0.043; p = 0.953). The adjusted mean percentage of necrotic tissue of both groups showed a significant decrease over time (F(10,235) = 5.65; p <0.001), but no significant differences were found between the groups (F (1,244) = 0.487; p = 0.486).

Conclusion CDHP is equivalent to CHG and is an alternative in wound management and wound bed preparation for wounds with cavities.

Keywords

chitosan dressing - full-thickness wound - cavity wounds - granulation

Authors' Contributions

Nur Azida Mohd Nasir was involved in writing original draft, investigation, data curation, and visualization. Ahmad Sukari Halim contributed to conceptualization, validation, investigation, resources, writing and review, supervision, project administration and acquisition. Arman Zaharil Mat Saad (USM) contributed to project administration, methodology, investigation, writing and review, supervision. Fatimah Mohd Noor (HKL and MOH) and Farrah-Hani Imran (HUKM & MOH) were involved in project administration, investigation, writing and review, and supervision. Mohd Nazri Yusof (IIUM) supervised and wrote and reviewed the manuscript. Ariff Sarifudin (IIUM) did the project administration and wrote and reviewed the manuscript. Nor Sa'adah Bachok was involved in methodology, formal analysis, and writing and review. Zanariah Ujang, Ahamd Hazri Ab Rashid, Kartini Norsal, Kamaruddin Hashim, and Norimah Yusof contributed to validation, resources, writing and review.


Compliance with Ethics Requirements

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.


All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation from The Research Ethics Committee (Human) of Universiti Sains Malaysia (FWA Reg. No. 00007718; IRB Reg. No: 00004494) and Research Ethics Committee of Universiti Kebangsaan Malaysia (JEPUKM) (No: FF-285–2012). This study was also approved by Medical Research and Ethic Committee, Ministry of Health Malaysia (NMRR-11–948–10565) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.


Clinical Trial Registration

NMRR-11–948–10565.




Publication History

Article published online:
22 December 2022

© 2022. Association of Plastic Surgeons of India. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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