Sutures Versus Glue in Laparoscopic Port Site Closure. (STILS)

February 18, 2019 updated by: Noel Edward Donlon, St. James's Hospital, Ireland

The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.

Cosmesis postoperatively is an important consideration for both patients and surgeons and consequently surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds.

Therefore the investigators are using two different close techniques for laparoscopic wounds. These are; 1. sutures with steri-strips and 2. adhesive bond.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Ireland
      • Dublin, Ireland
        • St. James Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.

Exclusion Criteria:

  • Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suture & steri-strips
Other: 4-0 Monocryl
sutures and steri-strips
Other Names:
  • sutures and steri strips
Active Comparator: Adhesive Glue
Other: Adhesive Glue
Adhesive Glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmesis
Time Frame: 6 months
Cosmetic outcome being graded by patient and clinician via questionnaire. Observer scar assessment form (1-10) 1 = worst result possible, 10 being the best result possible.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection (SSI).
Time Frame: 6 months
Any superficial site infection which requires antibiotic use or wound complication such as dehisence. This information will be obtained from clinic.
6 months

Collaborators and Investigators

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

Sponsor

St. James's Hospital, Ireland

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 (Actual)

February 11, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

September 2, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SJH 2019-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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