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Clinical Trials/NCT03989648
NCT03989648UnknownNot Applicable

Comparison of the Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Minimally Invasive Total Knee Arthroplasty : A Randomized Controlled Trial

Navamindradhiraj University1 site in 1 country100 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Fromme-Boezaart surgical field scale

Study Overview

Brief Summary

To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Primary osteoarthritis of knee

Exclusion Criteria

  • •There are deep vein thrombosis and pulmonary embolism
  • •There are bleeding disorder,hypercoagulability,peripheral arterial disease and chronic venous insufficiency
  • •Take blood clotting pills
  • •Have had total knee arthroplasty
  • •BMI > 30

Arms & Interventions

Esmarch bandages

Active Comparator

Intervention: Esmarch bandages (Other)

simple leg elevation

Active Comparator

Intervention: simple leg elevation (Other)

Outcomes

Primary Outcomes

Fromme-Boezaart surgical field scale

Time Frame: Immediate after surgery

Fromme-Boezaart surgical field scale is visual assessment of surgical field using a 6-point scale (min=0, max=5) 0 mean No bleeding 1. mean Slight bleeding ; no suctioning of blood required 2. mean Slight bleeding ; occasional suctioning required. Surgical field not threatened 3. mean Slight bleeding ; frequent suctioning required. Bleeding threatens surgical filed a few seconds after suction is removed 4. mean Moderate bleeding ; frequent suctioning required. Bleeding threatens surgical field directly after suction is removed 5. mean Severe bleeding ; constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible 0=best possible operating conditions and dryness of the surgical field; 5= worst possible conditions

Secondary Outcomes

  • Numerical rating scale: NRS at 24 hrs(24 hours after surgery)
  • Numerical rating scale: NRS at 72 hrs(72 hours after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Satit Thiengwittayaporn

Associate Professor

Navamindradhiraj University

Study Sites (1)

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