Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

NCT ID: NCT02426762

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sealant skin closure

A quick skin sealant would be applied after laparoscopic surgery. All abdominal wounds are sealed by smearing the quick sealant (skin adhesive) twice. No additional gauges should be appended on wound areas. No further wound care should be applied unless any effusion or bleeding emerged around it.

Group Type: EXPERIMENTAL

Laparoscopic surgery

Intervention Type: PROCEDURE

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)

Skin sealant

Intervention Type: DEVICE

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.

Interventions

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)

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Skin adhesive

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wu Song

Director of Center of Gastrointestinal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Song, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yujie Yuan, MD

Role: CONTACT

condor.yyj@gmail.com

+8615018492852

Facility Contacts

Yujie Yuan, MD

Role: primary

condor.yyj@gmail.com

+86 15018492852

Other Identifiers

2015[122]

Identifier Type: -

Identifier Source: org_study_id