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Prospective, randomized controlled, blind, multicenter, non-inferior clinical trial protocol to evaluate the safety and efficacy of "medical adhesive" for skin incision surface edge closure

Prospective, randomized controlled, blind, multicenter, non-inferior clinical trial protocol to evaluate the safety and efficacy of "medical adhesive" for skin incision surface edge closure

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088730
Enrollment
Unknown
Registered
2024-08-26
Start date
2023-12-23
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Abdominal minimally invasive surgical wound

Interventions

experimental group:use of medical adhesive
control group:no medical adhesive is used

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Subjects with indication for abdominal surgery; 2) Age 18-75 years old, male or female; 3) General condition: no serious cardiac, renal, or hepatic dysfunction; 4) Voluntary application of medical adhesive for treatment and cooperation with follow-up; 5) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) The subject refuses to sign the informed consent; (2) Expected surgical incision =7cm; (3) High risk of general anesthesia (ASA=?); (4) The incision is located at the mucosal skin junction or in a naturally hairy area; (5) There is skin disease around the incision; (6) The subject is allergic; (7) Allergic to narcotic drugs; (8) Uncontrolled hypertension, such as blood pressure >159/99mmHg; (9) Surgical site infection or injury, and uncontrolled systemic infection, such as white blood cells > 9.5×10^9/L; (10) Subjects with abnormal coagulation function, PLT 43.5; Aspirin, warfarin, heparin and other similar drugs have been taken or have been taken within 7 days while on anticoagulant therapy; Long-term or ongoing use of hormonal drugs and other similar drugs; (11) Body mass index =28kg/m2; (12) diabetic patients with uncontrolled blood sugar; (13) The subject has impaired immune system or autoimmune system disease; (14) neurological disorders or neuropathy, mental disorders or manic psychosis whose condition is not effectively controlled, mental illness, mental abnormality or abnormal motivation, and a lack of necessary understanding of the risks involved in surgical procedures; (15) Pregnant and lactating women; (16) Participants in clinical trials of other drugs or medical devices within 3 months; (17) The subjects were unwilling to follow up later or were unable to complete the follow-up plan.

Design outcomes

Primary

MeasureTime frame
Incision non-cracking rate at 7 days after use of medical adhesive;

Secondary

MeasureTime frame
Grade of incision healing;Evaluation of incision scar;The time required to complete the operation;Subject's pain perception;Medical adhesive usage;Number of cuts cracking rate;Subject satisfaction;

Countries

China

Contacts

Public ContactZhiying Yang

China-Japan Friendship Hospital

yangzhy@aliyun.com+86 186 0003 6106

Outcome results

None listed

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