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

Esmarch Bandages Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03989648
• Other study ID #: COA 028/2562
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esmarch Bandages
• Simple Leg Elevation

Intervention

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.
• simple leg elevation
simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fromme-Boezaart surgical field scale	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	Immediate after surgery
Secondary	Numerical rating scale: NRS at 24 hrs	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
Secondary	Numerical rating scale: NRS at 72 hrs	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