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

Sponsor

Navamindradhiraj University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03989648

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esmarch Bandages Simple Leg Elevation	Other: Esmarch bandages Other: simple leg elevation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fromme-Boezaart surgical field scale [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 Outcome Measures

Numerical rating scale: NRS at 24 hrs [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navamindradhiraj University	Dusit	Bangkok	Thailand	10300

Sponsors and Collaborators

Navamindradhiraj University

Investigators

Principal Investigator: Satit Thiengwittayaporn, M.D., Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University

ClinicalTrials.gov Identifier:

NCT03989648

Other Study ID Numbers:

COA 028/2562

First Posted:

Jun 18, 2019

Last Update Posted:

Aug 31, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Exsanguination

Study Results

No Results Posted as of Aug 31, 2021