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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


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

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