Status:
COMPLETED
Graduated Compression Stockings (GCS) Pilot Substudy
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
BSN Medical Inc
McMaster University
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Randomized to PeriOperative ISchemic Evaluation-2 Trial (POISE-2 Trial)
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01234064
Start Date
November 1 2010
End Date
December 1 2011
Last Update
January 18 2012
Active Locations (1)
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1
Henderson Hospital
Hamilton, Ontario, Canada