Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02426762

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complications of Surgical Procedures Surgical Site Infection Gastric Cancer Colorectal Cancer Gastrointestinal Stromal Tumor Inflammatory Bowel Disease Diverticula	Procedure: Laparoscopic surgery Device: Skin sealant	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: Skin adhesive

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

Skin adhesive

Outcome Measures

Primary Outcome Measures

freedom from surgical site infection [within the first 30 days after laparoscopic surgery]
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.

Secondary Outcome Measures

Length of hospital stay [an expected average of 4 weeks]
All participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Pain Scores on the Visual Analog Scale [within the first 30 days after laparoscopic surgery]
Postoperative pain would be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.