Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

August 11, 2015 updated by: Wu Song, First Affiliated Hospital, Sun Yat-Sen University

Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  • 4-5 trocar-produced incisions (5/10mm, minor incision)
  • 1 sample-retrieval incision (4-5cm, small incision)
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 Names:
  • Skin adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first 30 days after laparoscopic surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
within the first 30 days after laparoscopic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Wu Song, MD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (ESTIMATE)

April 27, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015[122]

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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