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Evaluation of the safety and preliminary efficacy of a new gel dressing for wound healing

Evaluation of the safety and preliminary efficacy of a new gel dressing for wound healing

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116722
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Wound

Interventions

Experimental group:All patients were treated with wound debridement, application and replacement of gel dressings according to the uniform protocol. Data were collected at fixed follow-up points (base
Control group:All patients were treated with wound debridement, dressing and replacement of gauze or vaseline gauze according to the uniform protocol. Data were collected at fixed follow-up points (ba

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, no gender restrictions; 2. Clinically diagnosed with a skin wound (such as donor site, surgical wound, or debridement of second-degree burns), with a wound area between 2 cm^2 and 20 cm^2; 3. Willing to participate in this study and sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals known to be allergic to hydrogel components or the components of the control dressing; 2. Wounds accompanied by active severe bleeding or requiring vascular anastomosis; 3. Patients with systemic diseases that severely affect healing, such as uncontrolled diabetes (HbA1c > 9%), severe malnutrition (albumin < 25g/L), or immune deficiencies (e.g., AIDS, long-term high-dose immunosuppressant use); 4. Patients with autoimmune diseases involving the skin, or wounds caused by malignant tumors; 5. Pregnant or breastfeeding women; 6. Individuals who have participated in other interventional clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Complete wound healing rate on day 28 after treatment;blood routine examination indicators;routine urine test indicators;Blood biochemical indicators;Biochemical indicators of exudate from the wound;

Secondary

MeasureTime frame
Evaluation of wound healing;Evaluation of dressing performance;Scar evaluation;Infection and Safety Monitoring;

Countries

China

Contacts

Public ContactYin Pengbin

Chinese PLA General Hospital

yinpengbin@gmail.com+86 150 1049 7628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026