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To evaluate the safety and efficacy of tissue repair medical adhesive combined with spray gun for intestinal wound closure: a multi-center, randomized, single-blind, positive parallel controlled, non-inferiority clinical trial

To evaluate the safety and efficacy of tissue repair medical adhesive combined with spray gun for intestinal wound closure: a multi-center, randomized, single-blind, positive parallel controlled, non-inferiority clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092175
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-11-19
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Intestinal wound closure

Interventions

Control group:The intestinal wound was closed with titanium clip
Trial group:The intestinal wound was closed with tissue repair medical glue combined with spray gun

Sponsors

Shenzheng Second People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-70 years old; 2.The diameter of the intestinal lesions ranged from 0.5 to 3cm, and no clear perforation was found after resection of the lesions. 3.Patients who can tolerate and cooperate with endoscopy; 4.Those who voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Have participated in another clinical trial within 90 days before the start of the trial; 2.Within 90 days before the trial received or planned to receive chemoradiotherapy during the trial; 3.Patients with malignant tumors; 4.Patients with severe cardiopulmonary diseases, allergic diseases, uncorrected infections or other high-risk conditions; 5.Severe anemia: hemoglobin concentration less than 60g/L, which is considered by the investigators to be clinically significant; 6.Coagulation dysfunction: abnormal coagulation function indexes (prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR), fibrinogen (FIB)) and clinical significance; 7. Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than 3 times the normal value; 8.Abnormal renal function: creatinine and urea nitrogen/urea ratio exceeded the normal range and were judged by the investigator as clinically significant; 9.Patients who took antithrombotic drugs (antiplatelet drugs, thrombolytic drugs, anticoagulant drugs) within 7 days before surgery; 10.Pregnant or lactating women; 11.Allergic to human serum albumin and anesthetic drugs; 12.Patients with mental disorders, unable to cooperate with endoscopic examination; 13.The location of the wound that was difficult to apply the study product or to observe with endoscopy; 14.Other researchers considered inappropriate.

Design outcomes

Primary

MeasureTime frame
S-phase acquisition rate 1 month after surgery;

Secondary

MeasureTime frame
Effective rate of spraying gun;The operation time of wound closure surgery;S-phase acquisition rate 3 months after surgery;Wound area closure rate;Rate of delayed bleeding;Spray gun push speed error;

Countries

China

Contacts

Public ContactSun Dayong

Shenzheng Second People‘s Hospital

szsesdy@163.com+86 136 1290 8866

Outcome results

None listed

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