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

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ClinicalTrials.gov Identifier: NCT03843866
Recruitment Status : Unknown
Verified February 2019 by Noel Edward Donlon, St. James's Hospital, Ireland.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Noel Edward Donlon, St. James's Hospital, Ireland

Study Description
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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
Cosmetic Outcome Infection Cost Other: 4-0 Monocryl Other: Adhesive Glue Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 11, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 2, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Suture & steri-strips Other: 4-0 Monocryl
sutures and steri-strips
Other Name: sutures and steri strips
Active Comparator: Adhesive Glue Other: Adhesive Glue
Adhesive Glue


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.

Exclusion Criteria:

  • Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843866


Locations
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Ireland
St. James Hospital
Dublin, Ireland
Sponsors and Collaborators
St. James's Hospital, Ireland
More Information
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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: February 18, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No