Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

NCT02426762 | Unknown Phase 2 DMC

• 1 other identifier: 2015[122]
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of hospital stay

  an expected average of 4 weeks

• Pain Scores on the Visual Analog Scale

  within the first 30 days after laparoscopic surgery

Study Arms (1)

Sealant skin closure

EXPERIMENTAL

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; Device: Skin sealant

Interventions

Laparoscopic surgery PROCEDURE

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)

Sealant skin closure

Skin sealant DEVICE

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.

Also known as: Skin adhesive

Sealant skin closure

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Stomach Neoplasms; Colorectal Neoplasms; Gastrointestinal Stromal Tumors; Inflammatory Bowel Diseases; Diverticulum

Interventions

Laparoscopy; Surgical Tape

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastroenteritis; Diverticular Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Wu Song, MD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Yuan, MD

CONTACT

+8615018492852; condor.yyj@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center of Gastrointestinal Surgery

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

CN (1)