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STILS: Sutures Versus Glue in Laparoscopic Port Site Closure.

Sponsor
St. James's Hospital, Ireland (Other)
Overall Status
Unknown status
CT.gov ID
NCT03843866
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
6.7
Anticipated Duration (Months)
30
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 4-0 Monocryl
  • Other: Adhesive Glue
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.
Actual Study Start Date :
Feb 11, 2019
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Sep 2, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Cosmesis [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.

    Secondary Outcome Measures

    1. Surgical site infection (SSI). [6 months]

      Any superficial site infection which requires antibiotic use or wound complication such as dehisence. This information will be obtained from clinic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.
    Exclusion Criteria:
    • Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. James Hospital Dublin Ireland

    Sponsors and Collaborators

    • St. James's Hospital, Ireland

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noel Edward Donlon, General Surgery Specialist Registrar, St. James's Hospital, Ireland
    ClinicalTrials.gov Identifier:
    NCT03843866
    Other Study ID Numbers:
    • SJH 2019-1.0
    First Posted:
    Feb 18, 2019
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 20, 2019