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Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

Primary Purpose

Complications of Surgical Procedures, Surgical Site Infection, Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Laparoscopic surgery
Skin sealant
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications of Surgical Procedures focused on measuring skin sealant, laparoscopic surgery, surgical site infection, wound healing

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sealant skin closure

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of hospital stay
All participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Pain Scores on the Visual Analog Scale
Postoperative pain would be recorded.

Full Information

First Posted
April 22, 2015
Last Updated
August 11, 2015
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02426762
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sealant skin closure
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Skin sealant
Other Intervention Name(s)
Skin adhesive
Intervention Description
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.
Primary Outcome Measure Information:
Title
freedom from surgical site infection
Description
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.
Time Frame
within the first 30 days after laparoscopic surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
All participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Time Frame
an expected average of 4 weeks
Title
Pain Scores on the Visual Analog Scale
Description
Postoperative pain would be recorded.
Time Frame
within the first 30 days after laparoscopic surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujie Yuan, MD
Phone
+8615018492852
Email
condor.yyj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Song, MD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujie Yuan, MD
Phone
+86 15018492852
Email
condor.yyj@gmail.com

12. IPD Sharing Statement

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Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

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