An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds

Condition(s) studied

Investigational drug(s) / intervention(s)

antimicrobial absorbable wound dressing: Perform wound bed preparation per clinical routine protocols . Choose an appropriately sized product based on wound dimensions. Peel open the outer aluminum foil pouch from the hermetically sealed edge; the inner pouch remains sterile and may be placed in a sterile field . If necessary, rinse surgical gloves with powder-free solution before handling the product. The material can be trimmed in either moist or dry conditions. Sterile room-temperature irrigation solution may be used for moistening as needed Place either side of the product against the wound, ensuring complete coverage with slight overhang beyond the wound edge. Re-moisten the product with sterile room-temperature irrigation solution if required . Use an appropriate secondary dressing to maintain adherence and prevent displacement.

Study summary

Antimicrobial absorbable wound dressing is a novel polyester-based degradable dressing. Previous preclinical studies have demonstrated promising efficacy, with a 3-week wound area reduction rate of 63.53% in large animal models, outperforming foreign counterparts (49.47%), without significant adverse reactions observed during application. Toxicological risk assessment confirms acceptability, and small animal model studies show no abnormalities in toxicity or sensitization. However, current evidence lacks clinical validation, particularly regarding efficacy and safety in chronic non-healing wounds.

This study integrates modern clinical evaluation methods with chronic wound staging theory to systematically investigate the effectiveness and safety of antimicrobial absorbable wound repair materials in treating chronic non-healing wounds. The research aims to identify optimal indications and provide robust evidence for its clinical efficacy and safety.

Eligibility

Primary outcome measure(s)

• Wound Area Reduction Rate at 3 Weeks — Day 21±2
  The 3-week wound area reduction rate (%) is calculated as: Reduction Rate (%) = （Baseline Wound Area (D0)-Wound Area Post-Treatment (D21)）/Baseline Wound Area (D0) × 100%

Trial sites (1)

More Peking University Third Hospital trials in China

Other trials for the same condition