NCT02426762

Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic surgery	Various laparoscopic operations are performed for participants. Once all surgical procedures are successfully applied, surgical wounds which are associated with laparoscopic surgery would be sealed by a quick sealant. In all, the following surgical wounds would be left: * 4-5 trocar-produced incisions (5/10mm, minor incision) * 1 sample-retrieval incision (4-5cm, small incision)
DEVICE	Skin sealant	After surgery, a quick skin sealant is applied in two layers of each wound to achieve skin closure. The sealant would be smeared twice on the wound area with 30 seconds of dry time required to form a firm seal.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-04-27
• Last updated: 2015-08-13

Locations

1 site across 1 country: China