Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 1, 2022

Interventions

  • Other: Esmarch bandages
    • Esmarch bandage (also known as Esmarch’s bandage for surgical haemostasis or Esmarch’s tourniquet) in its modern form is a narrow (5 to 10 cm wide) soft rubber bandage that is used to expel venous blood from a limb (exsanguinate) that has had its arterial supply cut off by a tourniquet.
  • Other: simple leg elevation
    • simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb

Arms, Groups and Cohorts

  • Active Comparator: Esmarch bandages
  • Active Comparator: simple leg elevation

Clinical Trial Outcome Measures

Primary Measures

  • 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 mean Slight bleeding ; no suctioning of blood required mean Slight bleeding ; occasional suctioning required. Surgical field not threatened mean Slight bleeding ; frequent suctioning required. Bleeding threatens surgical filed a few seconds after suction is removed mean Moderate bleeding ; frequent suctioning required. Bleeding threatens surgical field directly after suction is removed 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 Measures

  • Numerical rating scale: NRS at 24 hrs
    • Time Frame: 24 hours after surgery
    • NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain
  • Numerical rating scale: NRS at 72 hrs
    • Time Frame: 72 hours after surgery
    • NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Navamindradhiraj University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Satit Thiengwittayaporn, Associate Professor – Navamindradhiraj University
  • Overall Official(s)
    • Satit Thiengwittayaporn, M.D., Principal Investigator, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.