Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery
|ClinicalTrials.gov Identifier: NCT02426762|
Recruitment Status : Unknown
Verified August 2015 by Wu Song, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : April 27, 2015
Last Update Posted : August 13, 2015
|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|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
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:
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 Name: Skin adhesive
- freedom from surgical site infection [ Time Frame: 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.
- Length of hospital stay [ Time Frame: 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 [ Time Frame: within the first 30 days after laparoscopic surgery ]Postoperative pain would be recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426762
|Contact: Yujie Yuan, MDemail@example.com|
|The First Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Yujie Yuan, MD +86 15018492852 firstname.lastname@example.org|
|Principal Investigator:||Wu Song, MD||First Affiliated Hospital, Sun Yat-Sen University|