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

NCT03989648 | Unknown

• 1 other identifier: COA 028/2562
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esmarch Bandages; Simple Leg Elevation

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (2)

• Numerical rating scale: NRS at 24 hrs

  24 hours after surgery

• Numerical rating scale: NRS at 72 hrs

  72 hours after surgery

Study Arms (2)

Esmarch bandages

ACTIVE COMPARATOR

Other: Esmarch bandages

simple leg elevation

ACTIVE COMPARATOR

Other: simple leg elevation

Interventions

Esmarch bandages OTHER

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.

Esmarch bandages

simple leg elevation OTHER

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

simple leg elevation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary osteoarthritis of knee

You may not qualify if:

• 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

Sponsors & Collaborators

• Navamindradhiraj University: lead

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

Related Publications (1)

• Chaitantipongse S, Hongku N, Thiengwittayaporn S. Optimizing surgical field visualization in total knee arthroplasty: a randomized controlled trial comparing esmarch bandages and simple leg elevation. J Orthop Surg Res. 2025 May 13;20(1):455. doi: 10.1186/s13018-025-05853-6.

  PMID: 40355975 DERIVED

Study Officials

• Satit Thiengwittayaporn, M.D.

  Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: June 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TH (1)