Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

Sun Yat-sen University

Status and phase: Unknown; Phase 2

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

Treatments: Device: Skin sealant; Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02426762

2015[122]

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Sealant skin closure

Experimental group

Description:

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.

Treatment:

Procedure: Laparoscopic surgery

Device: Skin sealant