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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03989648
Enrollment
100
Registered
2019-06-18
Start date
2019-06-01
Completion date
2022-12-31
Last updated
2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esmarch Bandages, Simple Leg Elevation

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.

Interventions

OTHEREsmarch 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.

OTHERsimple leg elevation

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

Sponsors

Navamindradhiraj University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fromme-Boezaart surgical field scaleImmediate after surgeryFromme-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

Secondary

MeasureTime frameDescription
Numerical rating scale: NRS at 24 hrs24 hours after surgeryNRS 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 hrs72 hours after surgeryNRS is a pain intensity assessment of patients using a 11 point scale (min=0, max=10) 0=no pain 10= worst pain

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026