The goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (ADM) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks. The main questions it aims to answer are: Does ADM gel reduce the size of chronic wounds more than alginate dressings after 12 weeks? Does ADM gel help wounds heal faster and improve quality of life for patients? Researchers will compare ADM gel to alginate dressings to see if the ADM gel leads to better healing results and fewer complications. Participants will: Be randomly assigned to receive either ADM gel or alginate dressing. Have the treatment applied directly to their cleaned wound. Attend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
An injectable, sterile acellular dermal matrix (ADM) gel derived from processed biological tissue, designed to promote healing in chronic wounds. The gel is injected directly onto the wound bed following standard debridement and serves as a biocompatible scaffold to support granulation tissue formation, epithelialization, and wound closure. After application, the wound is covered with a standard secondary dressing. Dressing changes are performed every 2 to 3 days or as clinically indicated.
A sterile, absorbent alginate wound dressing composed of natural polysaccharide fibers derived from seaweed. Following standard debridement, the alginate dressing is applied directly to the wound bed to manage exudate and maintain a moist wound environment conducive to healing. The dressing is covered with a secondary dressing and changed according to the manufacturer's instructions and clinical protocol.
Alzahra hospital
Isfahan, Iran
Wound surface area (cm²) at Week 12, adjusted for baseline wound size
Wound surface area is measured as length × width (in cm²) using digital planimetry. Comparison of wound size between groups at Week 12 will be conducted using ANCOVA, adjusting for baseline wound size and relevant covariates.
Time frame: Week 1 and 12
Time to complete wound healing (100% epithelialization)
Number of days from baseline to full wound closure, defined as 100% epithelialization with no drainage.
Time frame: Weekly up to 12 weeks
Rate of granulation tissue formation
Visual and digital assessment of granulation tissue coverage over time.
Time frame: Weekly up to 12 weeks
Rate of wound epithelialization
Proportion of wound area covered by new epithelium, assessed at each follow-up visit.
Time frame: Weekly up to 12 weeks
Incidence of complications (infection, necrosis, bleeding)
Number and type of wound-related adverse events recorded during follow-up.
Time frame: Up to 12 weeks
Quality of life score at Week 12
Patient-reported quality of life is assessed using the SF-36 questionnaire at baseline and Week 12. Group differences at Week 12 will be analyzed using ANCOVA, adjusting for baseline SF-36 scores.
Time frame: Weeks 1 and 12
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