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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02426762
• Other study ID #: 2015[122]
• Status: Recruiting
• Phase: Phase 2
• First received: April 22, 2015
• Last updated: August 11, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: August 2015
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yujie Yuan, MD
• Phone: +8615018492852
• Email: condor.yyj[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• The informed consent has been obtained from the patient.

• With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.

• Endurable laparoscopic surgery without conversion.

• With moderate/good ECOG health rating (PS): 0-1 score.

Exclusion Criteria:

• Pregnant woman or lactating woman.

• With confirmed distant metastasis in liver, lung, bones, or other organs.

• Intolerable laparoscopic operation or converted to open surgery.

• With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.

• With bad compliance or contraindication to enrollment.

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

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	freedom from surgical site infection	The study endpoint should be freedom from superficial surgical site infection (SSI) or deep SSI as defined by the Centers of Disease Control and Prevention National Nosocomial Infection Surveillance criteria.	within the first 30 days after laparoscopic surgery	Yes
Secondary	Length of hospital stay	All participants will be followed for the duration of hospital stay, an expected average of 4 weeks	an expected average of 4 weeks	No
Secondary	Pain Scores on the Visual Analog Scale	Postoperative pain would be recorded.	within the first 30 days after laparoscopic surgery	No