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Clinical application demonstration project of polyvinyl alcohol self-negative pressure material prepared by high internal phase emulsion method

Clinical application demonstration project of polyvinyl alcohol self-negative pressure material prepared by high internal phase emulsion method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114251
Enrollment
Unknown
Registered
2025-12-09
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Wound

Interventions

Experimental group:After enrollment, the wound was thoroughly cleaned and covered with polyvinyl alcohol negative pressure drainage wound protection material (Shanghai Medical Equipment Administration

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Research participants treated at any clinical trial center of this project from October 1, 2025 to September 31, 2028; 2. Aged between 18 and 60, with no gender restrictions; 3. Patients diagnosed with wounds, the factors causing the injury include but are not limited to: surgical incisions, trauma, burns, plastic surgery, etc; 4. The area of the wound is less than or equal to 5% TBSA; 5. The wound is located on the limbs, trunk, face, or neck; 6. After confirmation by a clinician, the wound requires dressing change treatment; 7. Those who agree to participate in this study and sign a written informed consent form; 8. No other non-compliance situations.

Exclusion criteria

Exclusion criteria: 1. Accompanied by life-threatening underlying diseases, such as high-risk coronary heart disease, and have not undergone formal treatment or have no willingness to undergo treatment for the underlying disease; 2. Patients with underlying diseases that significantly affect wound healing, such as diabetes, hypertension, autoimmune diseases, etc., and have not undergone formal treatment or are unwilling to undergo treatment specifically for their underlying diseases; 3. Research participants who are unable to cooperate well, such as those with mental illnesses, or those with poor compliance; 4. Those who have a known history of allergy or are allergic to two or more allergens, due to the presence of similar ingredients or other chemical structures in this product and the control product; 5. Pregnant or lactating women, as well as those who have plans to conceive; 6. Participated in other clinical studies within one month before enrollment; 7. Research participants who cannot be followed up for a long period of time; 8. Research participants who refuse to sign the written informed consent; 9. Those who, according to other researchers, are not suitable for participating in clinical research.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;

Secondary

MeasureTime frame
Wound healing cycle;

Countries

China

Contacts

Public ContactZheng Longpo

Shanghai Tenth People's Hospital

jinjiannavy@163.com+86 189 1768 4131

Outcome results

None listed

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