Esmarch BandagesNCT03989648
Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Total Knee Arthroplasty
A study testing Esmarch bandages and simple leg elevation in people with Esmarch Bandages and Simple Leg Elevation, run by Navamindradhiraj University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esmarch Bandages, Simple Leg Elevation
- What is being tested?
- Esmarch bandages and simple leg elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary osteoarthritis of knee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Esmarch bandages, simple leg elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmarch bandagesOther
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 elevationOther
simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb
| Study group | Role | What they receive |
|---|---|---|
| Esmarch bandages | Active comparator | Not described Receives: Other: Esmarch bandages |
| simple leg elevation | Active comparator | Not described Receives: Other: simple leg elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate after surgery
Secondary outcomes (2)
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
Measured: 24 hours after surgery
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
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Feb 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esmarch BandagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989648
- Sponsor's protocol ID
- COA 028/2562
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40355975
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03989648
- Acronym / sponsor ID
- COA 028/2562
- Conditions
- Esmarch Bandages, Simple Leg Elevation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esmarch bandages | Active comparator | Other: Esmarch bandages |
| simple leg elevation | Active comparator | Other: simple leg elevation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary osteoarthritis of knee
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esmarch bandagesEsmarch 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. | Other | Esmarch bandages |
| simple leg elevationsimple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb | Other | simple leg elevation |
Primary outcome
Fromme-Boezaart surgical field scale
Time frame: 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 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
2 secondary outcomes
Numerical rating scale: NRS at 24 hrs
Time frame: 24 hours after surgery
Numerical rating scale: NRS at 72 hrs
Time frame: 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 40355975Chaitantipongse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satit Thiengwittayaporn, M.D. principal investigator
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esmarch bandages and simple leg elevation in people with Esmarch Bandages and Simple Leg Elevation, run by Navamindradhiraj University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fromme-Boezaart surgical field scale (time frame: Immediate after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.