Wound HealNCT07261501
An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
A study testing antimicrobial absorbable wound dressing in people with Wound Heal and Wound Healing Delayed, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Wound Heal, Wound Healing Delayed
- What is being tested?
- antimicrobial absorbable wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yunfeng Li, Medical Doctor, +86 010-82267791, liyunfeng1106@163.com
About this study
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
- Being tested
- antimicrobial absorbable wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial absorbable wound dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | On the basis of standard clinical treatment, use of antimicrobial absorbable wound dressing for 3 weeks Receives: Device: antimicrobial absorbable wound dressing |
| control group | No intervention | standard clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Area Reduction Rate at 3 Weeks
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%
Measured: Day 21±2
Secondary outcomes (1)
Wound Healing Rate at 3 Weeks
The percentage of completely healing wound at 3 Weeks
Measured: Day 21±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261501
- Sponsor's protocol ID
- Long2025-CW-antibiodegrade
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds
- ClinicalTrials.gov ID
- NCT07261501
- Acronym / sponsor ID
- Long2025-CW-antibiodegrade
- Conditions
- Wound Heal, Wound Healing Delayed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: antimicrobial absorbable wound dressingOn the basis of standard clinical treatment, use of antimicrobial absorbable wound dressing for 3 weeks |
| control group | No intervention | –standard clinical treatment |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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***
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimicrobial absorbable wound dressingPerform 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. | Device | test group |
Primary outcome
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%
1 secondary outcome
Wound Healing Rate at 3 Weeks
Time frame: Day 21±2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antimicrobial absorbable wound dressing in people with Wound Heal and Wound Healing Delayed, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Area Reduction Rate at 3 Weeks (time frame: Day 21±2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.