Condition category
Surgery
Date applied
27/11/2009
Date assigned
15/12/2009
Last edited
20/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr William Beasley

ORCID ID

Contact details

Department of Gastrointestinal Surgery
Singleton Hospital
Abertawe Bro Morgannwg University NHS Trust
Sketty Lane
Swansea
SA2 8QA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/wmw01/55

Study information

Scientific title

Patient satisfaction and complications following laparoscopic wound closure with 2-octylcyanoacrylate or vicryl: a single blind randomised controlled trial

Acronym

Study hypothesis

Closure of laparoscopic wounds with tissue adhesives is associated with higher patient satisfaction and lower complication rates than with conventional suturing.

Ethics approval

Dyfed Powys Research Ethics Committee approved on the 3rd January 2007 (ref: 06/wmw01/55)

Study design

Single blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Laparoscopic general surgery

Intervention

Intervention: Laparoscopic wound closure with 2-cyanoacrylate tissue adhesive
Control: Laparoscopic wound closure with subcuticular stitches

Total follow up was six weeks.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Patient satisfaction in terms of wound appearance and wound closure technique. Measured at six weeks post-operatively.

Secondary outcome measures

1. Wound closure time, measured at the time of operation
2. Wound complications (dehisence, infection, resuturing), measured at six weeks post-operatively
3. Wound pain, measured at six weeks post-operatively
4. Antibiotic usage, measured at the time of operation
5. Unscheduled medical review, measured at six weeks post-operatively

Overall trial start date

01/02/2007

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. All adults (aged 18 years and over), both males and females
2. Elective, general surgical, laparoscopic patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Known 2-octylcyanoacrylate hypersensitivity
2. Conversion to open procedure

Recruitment start date

01/02/2007

Recruitment end date

01/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastrointestinal Surgery
Swansea
SA2 8QA
United Kingdom

Sponsor information

Organisation

Carmarthenshire NHS Trust (UK)

Sponsor details

Research and Development Office
Room 8
Mynydd Mawr Hospital
Upper Tumble
Llanelli
SA14 6BU
United Kingdom
+44 (0)1269 833397
ingaret.eden@carmarthen.wales.nhs.uk

Sponsor type

Government

Website

http://www.wales.nhs.uk/sites3/home.cfm?orgid=45

Funders

Funder type

Government

Funder name

Carmarthenshire NHS Trust (UK) - Research and Development Office (now known as Hywel Dda NHS Trust)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/05/2016: No publications found, verifying study status with principal investigator.