NCT03843866

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 12, 2019

Last Update Submit

February 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Surgical site infection (SSI).

    6 months

Study Arms (2)

Suture & steri-strips

ACTIVE COMPARATOR
Other: 4-0 Monocryl

Adhesive Glue

ACTIVE COMPARATOR
Other: Adhesive Glue

Interventions

sutures and steri-strips

Also known as: sutures and steri strips
Suture & steri-strips

Adhesive Glue

Adhesive Glue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James Hospital

Dublin, Ireland

Location

Related Publications (1)

  • Ramjit SE, Davey MG, Keelan S, Herlihy E, Dromey M, Garvey C, Nugent TS, Fawaz A, O'Connell L, Cunningham M, Fahy M, Ryan EJ, Moran B, Aljohmani L, Narayanasamy J, Kelly ME, Healy C, Donohoe C, Ravi N, Neary P, Reynolds JV, Donlon NE. Evaluating the use of absorbable sutures versus sTaples versus tIssue glue in laparoscopic port skin closure (STILS) trial: A prospective, multi-centre randomised clinical trial (RCT). Surgeon. 2025 Oct;23(5):306-312. doi: 10.1016/j.surge.2025.02.015. Epub 2025 Mar 17.

MeSH Terms

Conditions

Infections

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery Specialist Registrar

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 18, 2019

Study Start

February 11, 2019

Primary Completion

July 1, 2019

Study Completion

September 2, 2019

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations