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
- Conditions
- Abdominal minimally invasive surgical wound
- Registration Number
- ChiCTR2400088730
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Subjects with indication for abdominal surgery;<br> 2) Age 18-75 years old, male or female; <br>3) General condition: no serious cardiac, renal, or hepatic dysfunction; <br>4) Voluntary application of medical adhesive for treatment and cooperation with follow-up; <br>5) Voluntary signing of informed consent.
(1) The subject refuses to sign the informed consent;<br> (2) Expected surgical incision =7cm; <br>(3) High risk of general anesthesia (ASA=?); <br>(4) The incision is located at the mucosal skin junction or in a naturally hairy area;<br> (5) There is skin disease around the incision; <br>(6) The subject is allergic;<br> (7) Allergic to narcotic drugs;<br> (8) Uncontrolled hypertension, such as blood pressure >159/99mmHg;<br>(9) Surgical site infection or injury, and uncontrolled systemic infection, such as white blood cells > 9.5×10^9/L;<br> (10) Subjects with abnormal coagulation function, PLT < 100×10^9/L, INR < 0.8 or greater than 1.5, APTT < 28 or > 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; <br>(11) Body mass index =28kg/m2; <br>(12) diabetic patients with uncontrolled blood sugar; <br>(13) The subject has impaired immune system or autoimmune system disease; <br>(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;<br>(15) Pregnant and lactating women; <br>(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incision non-cracking rate at 7 days after use of medical adhesive;
- Secondary Outcome Measures
Name Time Method 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;