InjuryNCT06576869
Timing of Tourniquet Release
A study testing Upper extremity orthopedic surgeries. in people with Injury, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury
- What is being tested?
- Upper extremity orthopedic surgeries.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 9 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consented study subjects 18 years or older
- Subjects with any upper extremity injury or ailment that would require the use of a tourniquet while doing surgery
- Subject undergoing surgery by one of the six fellowship trained Orlando Health upper extremity surgeons previous listed
- Subject without prior surgery to the operative extremity
Who cannot join
- Subject under the age of 18 at the time of consent/enrollment
- Subject has had previous surgical procedures at the surgery site
- Subject with bleeding disorder comorbidities
- Subjects who have tourniquet released and then re-inflated during their procedure
- Subjects who do not have English as their preferred language and require an interpreter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Health Jewett Orthopedic Institute
Orlando, Florida, 32806
About this study
Official title: "Timing Of Tourniquet Release, A Prospective Randomized Trial"
This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. The study will compare objective data obtained intraoperatively as well as standard clinical outcome measures such as pain scores at routine follow up.
Read the detailed description
Patients will be enrolled prior to surgery and consented to participate in the study [HPJ2]. Patients will be enrolled by the research staff with a provider including attending and resident surgeons as well as advanced practiced providers that are assigned to the upper extremity team. A computerized random number generator will be used to randomize patient allocation to either study arm: closure without releasing the tourniquet vs releasing the tourniquet and then closing the incision. Randomization will occur at the time of surgery. In order to standardize the procedure a 4-inch ace wrap will be wrapped around the upper arm and a tourniquet will be placed over this in order to ensure adequate padding [HPJ3] [AW4]. At the conclusion of the surgical procedure but prior to skin closure, the randomized number will be revealed to the surgeon and the surgeon will either release the tourniquet or will keep the tourniquet inflated and then close the skin. After the surgery is completed, information will be collected on the intraoperative data collection form to include: • Length and exact location of incision• Whether the patient is on anticoagulant medication., o This includes type/dose of medicationo Duration for taking the medicationo Was the medication halted prior to surgery; if so, when• Surgeon performing the surgery• Surgical procedure• Surgery location (Ambulatory Care Center (ACC), Orlando Regional Medical Center (ORMC), etc.) • When tourniquet is dropped (before/after closure)• Tourniquet Time• Time from tourniquet release to closure• Total Surgical time (time from incision until complete skin closure) • Turnover time• Was electrocautery required to control any bleeding; if so, what type and what was electrocauterized? Clinical outcome measures collected during postoperative follow up. • Visual analog pain scale• Quick Disability of the Arm, Shoulder and Hand (DASH) form• Complications including hematoma size• Satisfaction with treatment (scale 1-5)o completely satisfied - 5, somewhat satisfied - 4, neither satisfied or dissatisfied - 3, partly dissatisfied - 2, completely dissatisfied - 1• Likely to recommend this surgery to a friend family member who has the same condition - yes or no Patients enrolled in the study will follow up in clinic at the following time intervals: 2 weeks, 10 weeks, and 6 months per standard of care.
- Conditions
- Injury
- Being tested
- Upper extremity orthopedic surgeries.
- Keywords
- Tourniquet study
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity orthopedic surgeries.Procedure or surgery
Upper extremity orthopedic surgeries that require the use of a tourniquet.
| Study group | Role | What they receive |
|---|---|---|
| A: Closure without releasing the tourniquet. | Active comparator | Tourniquet is dropped after closure. Receives: Procedure: Upper extremity orthopedic surgeries. |
| B: Releasing the tourniquet and then closing the incision | Active comparator | Tourniquet is dropped prior to closure. Receives: Procedure: Upper extremity orthopedic surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain scale
Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain
Measured: 2 weeks, 10 weeks and 6 months.
Quick DASH form
Assessment of symptoms and ability to perform certain activities.
Measured: 2 weeks, 10 weeks, 6 months.
Hematoma assessment
Performed by MD, assessment of the presence of a hematoma and if present, it is measured.
Measured: 2 weeks, 10 weeks, 6 months.
Satisfaction with surgery
Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition.
Measured: 2 weeks, 10 weeks, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start2 Jun 2022
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Lewellyn, Orlando Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576869
- Sponsor's protocol ID
- 22.028.02
- Status last verified
- Jul 2025
- First submitted
- 27 Aug 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the rights of our study participants, protected heath information will not be identified or shared.
Publications
Zhang P, Liang Y, He J, Fang Y, Chen P, Wang J. Timing of tourniquet release in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Apr;96(17):e6786. doi: 10.1097/MD.0000000000006786.
PubMed 28445317Fitzgibbons PG, Digiovanni C, Hares S, Akelman E. Safe tourniquet use: a review of the evidence. J Am Acad Orthop Surg. 2012 May;20(5):310-9. doi: 10.5435/JAAOS-20-05-310.
PubMed 22553103Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
PubMed 11412159
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Timing Of Tourniquet Release, A Prospective Randomized Trial"
- ClinicalTrials.gov ID
- NCT06576869
- Acronym / sponsor ID
- 22.028.02
- Conditions
- Injury
- Keywords
- Tourniquet study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 29 Aug 2024 (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.
This will be a prospective randomized clinical trial comparing clinical outcome measures in patients who undergo elective upper extremity surgery when tourniquet is dropped prior to closure as opposed to when tourniquet is dropped after closure. The study will compare objective data obtained intraoperatively as well as standard clinical outcome measures such as pain scores at routine follow up.
Detailed description
Patients will be enrolled prior to surgery and consented to participate in the study [HPJ2]. Patients will be enrolled by the research staff with a provider including attending and resident surgeons as well as advanced practiced providers that are assigned to the upper extremity team. A computerized random number generator will be used to randomize patient allocation to either study arm: closure without releasing the tourniquet vs releasing the tourniquet and then closing the incision. Randomization will occur at the time of surgery. In order to standardize the procedure a 4-inch ace wrap will be wrapped around the upper arm and a tourniquet will be placed over this in order to ensure adequate padding [HPJ3] [AW4]. At the conclusion of the surgical procedure but prior to skin closure, the randomized number will be revealed to the surgeon and the surgeon will either release the tourniquet or will keep the tourniquet inflated and then close the skin. After the surgery is completed, information will be collected on the intraoperative data collection form to include: • Length and exact location of incision• Whether the patient is on anticoagulant medication., o This includes type/dose of medicationo Duration for taking the medicationo Was the medication halted prior to surgery; if so, when• Surgeon performing the surgery• Surgical procedure• Surgery location (Ambulatory Care Center (ACC), Orlando Regional Medical Center (ORMC), etc.) • When tourniquet is dropped (before/after closure)• Tourniquet Time• Time from tourniquet release to closure• Total Surgical time (time from incision until complete skin closure) • Turnover time• Was electrocautery required to control any bleeding; if so, what type and what was electrocauterized? Clinical outcome measures collected during postoperative follow up. • Visual analog pain scale• Quick Disability of the Arm, Shoulder and Hand (DASH) form• Complications including hematoma size• Satisfaction with treatment (scale 1-5)o completely satisfied - 5, somewhat satisfied - 4, neither satisfied or dissatisfied - 3, partly dissatisfied - 2, completely dissatisfied - 1• Likely to recommend this surgery to a friend family member who has the same condition - yes or no Patients enrolled in the study will follow up in clinic at the following time intervals: 2 weeks, 10 weeks, and 6 months per standard of care.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Closure without releasing the tourniquet. | Active comparator | Procedure: Upper extremity orthopedic surgeries.Tourniquet is dropped after closure. |
| B: Releasing the tourniquet and then closing the incision | Active comparator | Procedure: Upper extremity orthopedic surgeries.Tourniquet is dropped prior to closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consented study subjects 18 years or older
- Subjects with any upper extremity injury or ailment that would require the use of a tourniquet while doing surgery
- Subject undergoing surgery by one of the six fellowship trained Orlando Health upper extremity surgeons previous listed
- Subject without prior surgery to the operative extremity
Key exclusion criteria (5 listed)
- Subject under the age of 18 at the time of consent/enrollment
- Subject has had previous surgical procedures at the surgery site
- Subject with bleeding disorder comorbidities
- Subjects who have tourniquet released and then re-inflated during their procedure
- Subjects who do not have English as their preferred language and require an interpreter.
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 |
|---|---|---|
| Upper extremity orthopedic surgeries.Upper extremity orthopedic surgeries that require the use of a tourniquet. | Procedure or surgery | A: Closure without releasing the tourniquet., B: Releasing the tourniquet and then closing the incision |
Primary outcome
Visual analog pain scale
Time frame: 2 weeks, 10 weeks and 6 months.
Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain
Quick DASH form
Time frame: 2 weeks, 10 weeks, 6 months.
Assessment of symptoms and ability to perform certain activities.
Hematoma assessment
Time frame: 2 weeks, 10 weeks, 6 months.
Performed by MD, assessment of the presence of a hematoma and if present, it is measured.
Satisfaction with surgery
Time frame: 2 weeks, 10 weeks, 6 months.
Patient to rate their satisfaction with their surgery and to indicate whether or not they would recommend the surgery to family/friends with the same condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Results publication: PubMed 28445317Zhang P, Liang Y, He J, Fang Y, Chen P, Wang J. Timing of tourniquet release in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Apr;96(17):e6786. doi: 10.1097/MD.0000000000006786.
- Results publication: PubMed 22553103Fitzgibbons PG, Digiovanni C, Hares S, Akelman E. Safe tourniquet use: a review of the evidence. J Am Acad Orthop Surg. 2012 May;20(5):310-9. doi: 10.5435/JAAOS-20-05-310.
- Results publication: PubMed 11412159Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
- Individual participant dataSharing planned: No. In order to protect the rights of our study participants, protected heath information will not be identified or shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity orthopedic surgeries. in people with Injury, run by Orlando Health, Inc. at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analog pain scale (time frame: 2 weeks, 10 weeks and 6 months.). The study lists 4 primary outcomes in all. 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 NCT06576869, which also lists 3 linked publications.
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 5 Aug 2025; AzTrials last refreshed its copy on 4 Nov 2026.