Clinical trial NCT02426762: Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery
Official title: Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Complications of Surgical Procedures
Surgical Site Infection
Gastric Cancer
Colorectal Cancer
Gastrointestinal Stromal Tumor
Inflammatory Bowel Disease
Diverticula
Keywords: skin sealant
laparoscopic surgery
surgical site infection
wound healing
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: freedom from surgical site infection
timeFrame: within the first 30 days after laparoscopic surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: an expected average of 4 weeks
measure: Pain Scores on the Visual Analog Scale
timeFrame: within the first 30 days after laparoscopic surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Wu Song, MD
role: PRINCIPAL_INVESTIGATOR
References: