Contact information
Type
Scientific
Primary contact
Prof A K Samy
ORCID ID
Contact details
Northern Lincolnshire & Goole Hospitals NHS Trust
Diana Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom
+44 01472 874111
ahmed.samy@nlg.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0672184853
Study information
Scientific title
Acronym
Study hypothesis
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 the presence and severity of varicosity recurrence shall be compared.
Ethics approval
Not provided at time of registration
Study design
Double blind (patient and assessor blind) randomised controlled Study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Varicose veins
Intervention
Randomisation and Blinding:
Randomisation will be computer generated using the Statistical Package for Social Sciences (SPSS) and shall occur only once informed consent has been obtained and following induction of general anaesthesia. Each treatment, either porcine dermal collagen patch or saphenofemoral junction ligation alone will be documented on paper and placed in numbered envelopes and sealed. The envelopes will then be opened in numerical order. The surgeon will not know which mesh is to be used until the time the envelope is opened. The patient and post-operative assessor will not know which mesh has been used in their operation.
A master list of the randomisation will be kept in the Research and Development Department and be used solely for code breaking purposes should any adverse events occur. Adverse events will be reported by study documentation and to the Trust Risk Management department in line with Trust procedure.
Surgery:
All surgery shall be performed under general anaesthesia. Patients shall receive deep vein thrombosis (DVT) prophylaxis where clinically appropriate and according to local protocols. Surgery shall be performed by the Principle and Co-Investigators using established standard techniques of saphenofemoral junction ligation and varicose vein surgery. Briefly, following dissection to demarcate the saphenofemoral junction all tributaries shall be ligated. Disconnection of the saphenofemoral junction shall then be followed by flush suture ligation using a polygalactin suture with stripping of the saphenous vein to below the knee. In the presence of bifid long saphenous veins each shall be disconnected and suture ligated separately. If randomized to PermacolTM group a small patch of porcine dermal collagen shall be sutured over the obliterated saphenofemoral junction prior to closure of the fascial layers. If randomized to the standard technique alone this step shall be omitted. Standardized wound closure and dressing shall be performed. Discharge shall be with standard simple analgesia after adequate voiding of urine and ambulation. It is anticipated that this shall be the same day for most patients. Patients shall receive instructions to remove their dressings on the third post-operative day and thereafter to wear a Class II compression stocking for 6 weeks.
Assessments:
At 1 and 5 years follow up, a Research Nurse assessor, blinded to the technique used, shall administer pain visual analogue scales and objective, validated measures of QoL; namely the Short Form 36TM (SF36TM) and EUROQOLTM questionnaires. Patients shall be clinically examined for evidence of recurrent varicose veins and an objective measure of severity recorded using the venous disability score (VDS), venous clinical severity score (VCSS) and venous segmental disease score (VSDS).
Patients shall undergo a hand held Doppler ultrasound examination of the saphenofemoral junction to document the presence of radiologically apparent recurrence. This shall be defined as the presence of a new vein with diameter at least 4 mm and with pathologic reflux in direct connection with incompetent varicose veins at thigh level.
Added 05 September 2008: recruitment never started on this site.
Intervention type
Drug
Phase
Not Specified
Drug names
porcine dermal collagen patch
Primary outcome measure
The study shall be designed to demonstrate a 50% reduction in the clinical presence of recurrence at 5 years. Therefore, the null hypothesis is that no statistically significant difference exists in the clinically assessed recurrence rates at 5 years between PermacolTM and standard surgical groups.
Secondary outcome measures
1. Annual clinical recurrence rates
2. Radiographically demonstrable recurrence rates at 1 year and 5 years
3. Visual analogue pain scores
4. SF36 and EUROQOL questionnaire scores
5. Local complication rate: fistula, haematoma, groin wound infection
6. Serious adverse event rates
Overall trial start date
10/07/2006
Overall trial end date
09/07/2011
Reason abandoned (if study stopped)
Never started.
Eligibility
Participant inclusion criteria
All patients with primary or recurrent, uni or bilateral varicose veins with clinical evidence of saphenofemoral incompetence and who fulfill the following criteria will be considered eligible for the trial:
1. Clinically fit for general anaesthesia
2. Have the need for saphenofemoral junction ligation during varicose vein surgery
3. Should have the legal age and ability to provide informed consent
4. Have no known allergies to the products being tested
5. Agree to their GP being informed of their participation
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
To achieve adequate compliance with the protocol and follow up it is anticipated that 80 patients in total will be recruited. 40 patients will be randomly allocated into each arm of the study.
Participant exclusion criteria
1. Patients not able or unwilling to provide informed consent
2. Undergoing formal anti-coagulation for previous thromboembolic phenomena
3. Known allergies to the products being investigated
4. Do not agree to their GP being informed of their participation
Recruitment start date
10/07/2006
Recruitment end date
09/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Grimsby
DN33 2BA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), R&D Department supports admin cost
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Permacol is provided free of charge by Tissue Science Laboratories (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
Basic results (scientific)
Publication list