Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

Colorectal Cancer Clinical Trial

Official title: Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.

Clinical Trial Description

• Study design: A prospective cohort study

• Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery.

• Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure.

• Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin.

• Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3).

• Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Complications of Surgical Procedures
• Diverticula
• Diverticulum
• Gastric Cancer
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Infection
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Surgical Site Infection
• Surgical Wound Infection

• NCT number: NCT02426762
• Study type: Interventional
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yujie Yuan, MD
• Phone: +8615018492852
• Email: condor.yyj@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2015
• Completion date: October 2015