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NCT03843866 Clinical Trial

Sutures Versus Glue in Laparoscopic Port Site Closure.

Infection Clinical Trial

— STILS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03843866
Other study ID # SJH 2019-1.0
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 11, 2019
Est. completion date September 2, 2019

Study information
Verified date February 2019
Source St. James's Hospital, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date September 2, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 4-0 Monocryl
sutures and steri-strips
• Adhesive Glue
Adhesive Glue

Locations
Country Name City State
Ireland St. James Hospital Dublin

Sponsors (1)
Lead Sponsor Collaborator
St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

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