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

NCT ID: NCT07261501

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

test group

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

Group Type: EXPERIMENTAL

antimicrobial absorbable wound dressing

Intervention Type: 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.

control group

standard clinical treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Long Zhang

Professor, Head of Wound Healing Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yunfeng Li, Medical Doctor

Role: primary

liyunfeng1106@163.com

+86 010-82267791

Other Identifiers

Long2025-CW-antibiodegrade

Identifier Type: -

Identifier Source: org_study_id