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
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