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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN43505974

Enrollment

100

Registered

2010-10-21

Start date

2006-07-10

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Generic Health Relevance and Cross Cutting Themes

Interventions

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 recurre

Eligibility

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
50% reduction in the clinical presence of recurrence at 5 years.	—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026