Cosmetic OutcomeSTILSNCT03843866
Sutures Versus Glue in Laparoscopic Port Site Closure.
A study testing 4-0 Monocryl and Adhesive Glue in people with Cosmetic Outcome and Infection, run by St. James's Hospital, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cosmetic Outcome, Infection, Cost
- What is being tested?
- 4-0 Monocryl and Adhesive Glue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 11 Feb 2019to 2 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.
Who cannot join
- Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cosmetic Outcome, Infection, Cost
- Being tested
- 4-0 Monocryl, Adhesive Glue
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-0 MonocrylOther
Also called sutures and steri strips
sutures and steri-strips
Adhesive GlueOther
Adhesive Glue
| Study group | Role | What they receive |
|---|---|---|
| Suture & steri-strips | Active comparator | Not described Receives: Other: 4-0 Monocryl |
| Adhesive Glue | Active comparator | Not described Receives: Other: Adhesive Glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start11 Feb 2019
- Primary completion1 Jul 2019 (estimated)
- Study completion2 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cosmetic OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Edward Donlon, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843866
- Sponsor's protocol ID
- SJH 2019-1.0
- Acronym
- STILS
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40102141
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.
- ClinicalTrials.gov ID
- NCT03843866
- Acronym / sponsor ID
- STILS / SJH 2019-1.0
- Conditions
- Cosmetic Outcome, Infection, Cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 2 Sep 2019 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture & steri-strips | Active comparator | Other: 4-0 Monocryl |
| Adhesive Glue | Active comparator | Other: Adhesive Glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.
Key exclusion criteria (1 listed)
- Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-0 MonocrylAlso: sutures and steri stripssutures and steri-strips | Other | Suture & steri-strips |
| Adhesive GlueAdhesive Glue | Other | Adhesive Glue |
Primary outcome
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.
1 secondary outcome
Surgical site infection (SSI).
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 40102141Ramjit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-0 Monocryl and Adhesive Glue in people with Cosmetic Outcome and Infection, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmesis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.