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A prospective study evaluating the safety and efficacy of povidone-iodine disinfectant hydrogel for the treatment of wound infections

A prospective study evaluating the safety and efficacy of povidone-iodine disinfectant hydrogel for the treatment of wound infections

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115050
Enrollment
Unknown
Registered
2025-12-22
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Wound infection

Interventions

Experimental group:Povidone-iodine disinfectant hydrogel

Sponsors

Jinshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Subjects who voluntarily participate in the study and have signed a written informed consent form; 2.No gender restriction; subjects must be aged 18 to 85 years (inclusive) at the time of signing the informed consent form. 3.Wound infections located on the extremities or trunk, with an area of 4-100 cm², involving the skin or subcutaneous tissue. These include infections of burn wounds, traumatic ulcers, pressure ulcers, venous ulcers, or diabetic ulcers, etc. 4.Subjects who have undergone bacteriological sample collection and tested positive by microscopic examination; 5.At least 2 of the following clinical manifestations of wound infection: local pus or inflammatory exudate, foul odor, erythema of the skin around the wound, tissue swelling or induration, warmth of the skin around the wound, local pain or tenderness.

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or lactating; 2.Infection/necrosis involves deep soft tissues such as the deep fascia and muscles, or forms a deep sinus tract,or face; 3.Subjects who did not undergo bacterial culture before enrollment; 4.Subjects with obvious manifestations of systemic infection, or those with severe systemic conditions that require systemic medication or surgical intervention; 5.Subjects with a history of previous tumors or those who require the use of immunosuppressants; 6.Subjects with severe diseases of the cardiovascular system, liver, kidneys, or hematological system; 7.Subjects with a history of schizophrenia, a history of other severe mental illnesses, or a history of drug or alcohol abuse 8.Subjects with a known allergy to this product; 9.Subjects who have participated in other clinical trials within the recent 3 months; 10.Subjects whom the investigator deems unable to comply with the protocol requirements to complete the study during the study period; 11.Researchers consider any situation in which the participants are not suitable for participating in this study

Design outcomes

Primary

MeasureTime frame
The effective rate of wound infection treatment on the 7th day after treatment;

Secondary

MeasureTime frame
Wound healing rate 7 days after treatment;

Countries

China

Contacts

Public ContactYunmin Cai

Jinshan Hospital of Fudan University

cymajj@126.com+86 189 3081 9161

Outcome results

None listed

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