Antibacterial absorbable polyester dressing for chronic non-healing wounds
An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
This trial will test an antimicrobial absorbable polyester dressing to see if it helps adults with chronic non-healing ulcers heal faster and safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Months to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07261501 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study will apply a novel antimicrobial absorbable polyester dressing to adults with chronic non-healing wounds and follow them using modern clinical wound-evaluation methods and established chronic wound staging. Prior large- and small-animal studies showed faster wound-area reduction and no major toxicity, but human clinical evidence is lacking. Participants will meet defined size, phase, and infection-stage criteria and will be monitored for wound-area change and safety outcomes. The goal is to identify optimal indications and generate clinical evidence on efficacy and tolerability at Peking University Third Hospital.
Who should consider this trial
Good fit: Adults aged 18–80 with chronic non-healing ulcers (1–35 cm²) that show no healing progression for ≥1 week, including wounds with local infection/colonization and in late necrotic, granulation, or epithelial migration phases, who can give informed consent.
Not a fit: Patients with severe unstable comorbidities, uncontrolled diabetes (fasting glucose >15 mmol/L or HbA1c >12%), active bleeding that prevents standard care, systemic/disseminated infection, critically low albumin/hemoglobin/platelets, or advanced cancer are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the dressing could speed wound closure and reduce infection risk for people with chronic non-healing ulcers.
How similar studies have performed: Preclinical large- and small-animal studies reported promising wound-area reduction and acceptable toxicity, but clinical human data for this specific absorbable antimicrobial dressing are currently lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.