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. 2013 Jun 10;2013(6):CD001486. doi: 10.1002/14651858.CD001486.pub2

Sykes 2000.

Methods Study design: RCT.
Method of randomisation: Sealed envelopes on day of operation.
Blinding of assessment: Unclear.
Exclusions post‐randomisation: None stated.
Losses to follow‐up: None stated.
Participants Country: UK.
Setting: Hospital.
No. of participants: 50.
Age mean (years): 49 (32 to 65) no tourniquet; 47 (29 to 80) tourniquet.
Gender: M:F 1:4 no tourniquet; 1:2 tourniquet.
Inclusion criteria: Unilateral SFJ ligation strip and avulsions.
Exclusion criteria: History of DVT or deep venous insufficiency, extensive anterior thigh veins, saphenopopliteal reflux.
Groups "similar" for age, sex and VV grade.
Interventions Treatment: Sterile Loquist (Boazal cuff) inflated to 120 mm Hg.
Control: no Boazal cuff.
All patients had SFJ ligation strip using disposable Astra vasistrip and avulsions. 30° head down tilt. Cotton wool and crepe bandages applied for 48 hrs then TED stockings for 2 weeks.
Outcomes Median blood loss:
 Treatment: 0 ml.
 Control: 125 ml (range 20 to 300); P < 0.01.
Mean operative time:
 Treatment: 30 mins (range 11 to 47).
 Control: 37 mins (range 18 to 50); P < 0.01.
Median area of bruising thigh at 7 days:
 Treatment: 77 cm² (range 30 to 429).
 Control: 179 cm²; P < 0.01.
Pain (VAS 0 to 10): No significant difference.
Patient activity over first week (VAS 0 to 7): No significant difference.
Cosmetic appearance at 6 weeks: No significant difference.
Notes 3 patients had temporary sensory neuralgia ‐ one in treatment group and two in control group.
Two patients had wound complications (one infection and one haematoma ‐ both in I2.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear