A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence

ISRCTN	ISRCTN43505974
DOI	https://doi.org/10.1186/ISRCTN43505974
Protocol serial number	6006
Sponsor	Northern Lincolnshire and Goole Hospitals NHS Foundation Trust (UK)
Funder	Tissue Science Laboratories PLC (UK)

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 18/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof A K Samy
Scientific

Diana, Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom

Study information

Primary study design	Observational
Study design	Multicentre non-randomised observational case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	A double-blind randomised controlled trial comparing porcine dermal collagen patch saphenoplasty with conventional saphenofermoral ligation to prevent recurrent saphenofemoral incompetence
Study objectives	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(s)	MREC approved, ref: 06/Q1105/27
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	50% reduction in the clinical presence of recurrence at 5 years.
Key secondary outcome measure(s)	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
Completion date	09/07/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/07/2006
Date of final enrolment	09/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Diana, Princess of Wales Hospital

Grimsby
DN33 2BA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2017: No publications found, verifying study status with principal investigator.