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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Wound Healing Delayed
• Intervention / Treatment: Device: antimicrobial absorbable wound dressing

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Yunfeng Li, Medical Doctor; Phone Number: +86 010-82267791; Email: liyunfeng1106@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age : 18-80 years
• Wound Type : Chronic non-healing ulcers* with no signs of healing progression for ≥1 week
• Wound Area : 1-35 cm²
• Infection Status : Local infection, contamination, or colonization** as classified by IWII Wound Infection Staging
• Wound Phase : Late necrotic stabilization phase, granulation phase, or epithelial migration phase***
• Consent : Voluntary participation with signed informed consent

Exclusion Criteria:

• Severe Comorbidities : Acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, or other critical conditions requiring stabilization
• Uncontrolled Diabetes : Fasting blood glucose >15 mmol/L or HbA1c >12%
• Active Wound Hemorrhage : Bleeding precluding standard wound therapy
• Critical Laboratory Values :

Serum albumin <20 g/L Hemoglobin <60 g/L Platelet count <50×10⁹/L

• Systemic Infection : Disseminated/systemic infection requiring antibiotic therapy
• Malignancy : Advanced cancer patients，Current radiotherapy/chemotherapy，Malignant (cancer-related) ulcers
• Untreated Burns : Full-thickness (third-degree) burns without escharotomy
• Active Autoimmune Disease : Flare-up phase of autoimmune disorders
• Pregnancy/Lactation : Pregnant or breastfeeding women
• Allergy : Hypersensitivity to absorbable wound repair materials or polyhexamethylene biguanide hydrochloride
• Non-compliance : Inability to cooperate or psychiatric disorders
• Investigator's Discretion : Any condition deemed to compromise wound healing or study adherence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; On the basis of standard clinical treatment, use of antimicrobial absorbable wound dressing for 3 weeks	Device: 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.
No Intervention: control group; standard clinical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Area Reduction Rate at 3 Weeks	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%	Day 21±2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Rate at 3 Weeks	The percentage of completely healing wound at 3 Weeks	Day 21±2

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Long2025-CW-antibiodegrade

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No