Graduated Compression Stockings (GCS) Pilot Substudy

Hamilton Health Sciences (HHS)

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Device: Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)

Device: No Graduated Compression Stockings

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01234064

GCS Pilot Substudy

Details and patient eligibility

About

This is a pilot substudy to the PeriOperative ISchemic Evaluation-2 Trial (POISE-2), to assess the feasibility of adding graduated compression stockings (GCS) to POISE-2 as an intervention.

Full description

Objective: To determine if thigh-level graduated compression stockings (below-knee graduated compression stockings may be used if thigh level graduated compression stockings are not feasible, such as after knee surgery), started before surgery and worn until discharge and for a minimum of 10 days (whichever is longer), reduce symptomatic venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) in the 30 days after surgery.

Enrollment

50 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Randomized to PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)

Exclusion criteria

Unable to wear a graduated compression stockings on a leg that has been operated on (e.g., below knee skin grafting)
Leg has not been operated on and graduated compression stockings cannot be worn on either leg (e.g. bilateral leg amputations or skin ulceration, allergy to material in the graduated compression stockings)
Graduated compression stockings cannot be fitted because the patient's legs are too big, or too small (not compatible with manufacturer's recommendations)
The responsible physician/nurse judges that graduated compression stockings are contraindicated because of: i) decreased circulation in the legs as evidenced by very pale, cyanotic, or gangrenous conditions; or ii) risk of stocking-induced skin necrosis due to an established sensory neuropathy with numbness to touch.