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A prospective, multicenter, randomized, parallel-controlled, superiority clinical trial to evaluate the safety and efficacy of light-cured wound closure bioadhesives for the treatment of donor site wounds

A prospective, multicenter, randomized, parallel-controlled, superiority clinical trial to evaluate the safety and efficacy of light-cured wound closure bioadhesives for the treatment of donor site wounds

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062108
Enrollment
Unknown
Registered
2022-07-22
Start date
2022-07-30
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

donor site wounds

Interventions

Experimental group:Light-Cured wound closure bioadhesives

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Gender is not limited, age 18-65 years old; 2.Skin grafting is required, the thickness of the skin grafting is 0.3 mm, and the area of the donor site is 40-100 cm2; 3.According to GCP regulations, informed consent has been obtained and an informed consent form has been signed

Exclusion criteria

Exclusion criteria: 1.Subjects with uncontrolled diabetes or diseases or conditions known to affect the wound healing process; 2.Severe abnormal coagulation function or severe abnormal liver and kidney function; 3.Patients with local or systemic acute or chronic infection known to be difficult to control; 4.Subjects who are allergic to product ingredients; 5.Severe heart, liver, kidney, pulmonary insufficiency and other diseases; 6.Severe mental illness, including severe hysteria, and lack of autonomy; 7.Patients with stroke or diseases associated with limb skin autonomic nerve dysfunction; 8.Subjects who need to use other hemostatic materials such as gelatin sponge, cellulose materials, fibrin glue; 9.Those who are in critical condition and it is difficult to make an exact evaluation of the safety and effectiveness of the product; 10.Pregnant or lactating women or subjects who intend to have children within six months; 11.Participated in other clinical trials in the last 3 months; 12.Drug or alcohol abusers in the past 3 months; 13.Subjects with any medical history which in the judgment of the investigator may interfere with the test results or increase the risk of the subjects.

Design outcomes

Primary

MeasureTime frame
wound healing time;

Secondary

MeasureTime frame
Photocuring effect of photocuring machine;hemostatic effect;pain score;

Countries

China

Contacts

Public ContactXia Zhaofan
xiazhaofan_smmu@163.com+86 21 81873213

Outcome results

None listed

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