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

August 30, 2021 updated by: Satit Thiengwittayaporn, Navamindradhiraj University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Navamindradhiraj University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Esmarch bandages
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.
Active Comparator: simple leg elevation
Other: simple leg elevation
simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediate after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after surgery
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
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navamindradhiraj University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA 028/2562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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