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

NCT07261501 | Recruiting DMC

• 1 other identifier: Long2025-CW-antibiodegrade
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal; Wound Healing Delayed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound Healing Rate at 3 Weeks

  Day 21±2

Study Arms (2)

test group

EXPERIMENTAL

On the basis of standard clinical treatment, use of antimicrobial absorbable wound dressing for 3 weeks

Device: antimicrobial absorbable wound dressing

control group

NO INTERVENTION

standard clinical treatment

Interventions

antimicrobial absorbable wound dressing DEVICE

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.

test group

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Wound Healing Center

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 3, 2025
• Study Start: November 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)