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

Primary Purpose

Esmarch Bandages, Simple Leg Elevation

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Esmarch bandages
simple leg elevation
Sponsored by
Navamindradhiraj University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esmarch Bandages

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Navamindradhiraj University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Esmarch bandages

simple leg elevation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
June 14, 2019
Last Updated
August 30, 2021
Sponsor
Navamindradhiraj University
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1. Study Identification

Unique Protocol Identification Number
NCT03989648
Brief Title
Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navamindradhiraj University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esmarch Bandages, Simple Leg Elevation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esmarch bandages
Arm Type
Active Comparator
Arm Title
simple leg elevation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Esmarch bandages
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
simple leg elevation
Intervention Description
simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb
Primary Outcome Measure Information:
Title
Fromme-Boezaart surgical field scale
Description
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
Time Frame
Immediate after surgery
Secondary Outcome Measure Information:
Title
Numerical rating scale: NRS at 24 hrs
Description
NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain
Time Frame
24 hours after surgery
Title
Numerical rating scale: NRS at 72 hrs
Description
NRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain
Time Frame
72 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satit Thiengwittayaporn, M.D.
Organizational Affiliation
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navamindradhiraj University
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

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

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