RecruitingNot ApplicableNCT07261501

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

Sponsor

Peking University Third Hospital

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Wound Heal Wound Healing Delayed

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

Min Age: 18 MonthsMax Age: 80 Years

Inclusion Criteria6

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 Criteria13

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

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Interventions

DEVICEantimicrobial 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.