Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6006
Study information
Scientific title
A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence
Acronym
Study hypothesis
The study aims to compare the use of porcine dermal collagen patch saphenoplasty with standard saphenofemoral flush ligation in primary and recurrent varicose vein surgery. Post-operative subjective and objective measures of presence and severity of varicosity recurrence shall be compared. This shall be the first study to establish the efficacy of Permacol™ in this setting, and shall use the following endpoints to test the given null hypothesis.
Ethics approval
MREC approved, ref: 06/Q1105/27
Study design
Multicentre non-randomised observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery
Intervention
1. Imaging investigations (non-radiation): Patients need to undergo a handheld Doppler ultrasound examination of the saphenofemoral junction to document the presence of radiologically apparent recurrence.
2. Other examinations: Patients shall be clinically examined for evidence of recurrent varicose veins
3. Questionnaire: A research nurse assessor, blinded to the technique used, shall administer a questionnaire at 1 and 5 years follow-up
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
50% reduction in the clinical presence of recurrence at 5 years.
Secondary outcome measures
1. Annual clinical recurrence rates
2. Local complication rate - fistula, haematoma, groin wound infection
3. Radiographically demonstrable recurrence rates at 1 year and 5 years
4. Serious adverse event rates
5. 36-item short form health survey (SF-36) and EUROQOL questionnaire scores
6. Visual analogue pain scores
Overall trial start date
10/07/2006
Overall trial end date
09/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/07/2006
Recruitment end date
09/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diana, Princess of Wales Hospital
Grimsby
DN33 2BA
United Kingdom
Sponsor information
Organisation
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Tissue Science Laboratories PLC (UK)
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