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; Arman Zaharil Mat Saad; Nor Sa'adah Bachok; Ahmad Hazri Ab Rashid; Zanariah Ujang; Kartini Noorsal; Norimah Yusof; Kamaruddin Hashim; Fatimah Mohd Nor; Farrah-Hani Imran; Nazri Mohd Yusof; Mohd Ariff Sharifudin; Ahmad Sukari Halim

doi:10.1055/s-0042-1759503

Indian Journal of Plastic Surgery, Inhaltsverzeichnis

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

Autor*innen

Nur Azida Mohd Nasir

¹Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia
Arman Zaharil Mat Saad

¹Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia

²Reconstructive Sciences Department, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
Nor Sa'adah Bachok

³Biostatistic and Research Methodology Unit, School of Medical Sciences, Universiti Sains Malaysia, Kelantan Malaysia
Ahmad Hazri Ab Rashid

⁴SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
Zanariah Ujang

⁴SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
Kartini Noorsal

⁴SIRIM Industrial Research, SIRIM Berhad, Shah Alam, Selangor, Malaysia
Norimah Yusof

⁵Nuclear Malaysia Agency, Kajang, Selangor, Malaysia
Kamaruddin Hashim

⁵Nuclear Malaysia Agency, Kajang, Selangor, Malaysia
Fatimah Mohd Nor

⁶Plastic and Reconstructive Surgery, Kuala Lumpur Hospital, Jalan Pahang, Kuala Lumpu, Malaysia
Farrah-Hani Imran

⁷Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpur, Malaysia
Nazri Mohd Yusof

⁸Orthopaedic Department, Kuliyyah of Medicine, International Islamic University Malaysia, Kuantan, Pahang, Malaysia
Mohd Ariff Sharifudin

⁹Faculty of Medicine, Universiti Sultan Zainal Abidin, Kuala Terengganu
Ahmad Sukari Halim

¹Reconstructive Sciences Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia

²Reconstructive Sciences Department, Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia

Abstract

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

Volltext

Referenzen

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