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NCT Number: NCT07261501

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.

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Key information

Conditions

Wound Heal Wound Healing Delayed

Age range

18 month–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Yunfeng Li, Medical Doctor

CONTACT

[email protected]

+86 010-82267791

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Wound Area Reduction Rate at 3 Weeks

    Time frame: Day 21±2

    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%

Secondary outcomes

  1. Wound Healing Rate at 3 Weeks

    Time frame: Day 21±2

    The percentage of completely healing wound at 3 Weeks

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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