Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Laparoscopic surgery
* Device: Skin sealant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sealant skin closure<br>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<br>* 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)<br>Device: Skin sealant<br>* 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.<br>* Other names: Skin adhesive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain Scores on the Visual Analog Scale | Postoperative pain would be recorded. | within the first 30 days after laparoscopic surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin sealant, laparoscopic surgery, surgical site infection, wound healing