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

Peking University

Status

Enrolling

Conditions

Wound Heal

Wound Healing Delayed

Treatments

Device: antimicrobial absorbable wound dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT07261501

Long2025-CW-antibiodegrade

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 months to 80 years old

Volunteers

No Healthy Volunteers

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