Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery
- Conditions
- Surgical Site InfectionColorectal CancerDiverticulaGastric CancerInflammatory Bowel DiseaseComplications of Surgical ProceduresGastrointestinal Stromal Tumor
- Interventions
- Procedure: Laparoscopic surgeryDevice: Skin sealant
- Registration Number
- NCT02426762
- Lead Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sealant skin closure Laparoscopic surgery 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. Sealant skin closure Skin sealant 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China