An interventional study of Upper extremity orthopedic surgeries. in Injury, sponsored by Orlando Health, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Orlando Health, Inc. · Not applicable, Interventional, and Basic science
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 214 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
Tourniquet is dropped after closure.
Procedure: Upper extremity orthopedic surgeries.
Tourniquet is dropped prior to closure.
Procedure: Upper extremity orthopedic surgeries.
Upper extremity orthopedic surgeries that require the use of a tourniquet.
Visual analog pain scale
Visual number scale to rate pain from 0-10 where 0 equals no pain and 10 equals worst possible pain
Time frame: 2 weeks, 10 weeks and 6 months.
Quick DASH form
Assessment of symptoms and ability to perform certain activities.
Time frame: 2 weeks, 10 weeks, 6 months.
Hematoma assessment
Performed by MD, assessment of the presence of a hematoma and if present, it is measured.
Time frame: 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.
Time frame: 2 weeks, 10 weeks, 6 months.
Plan to share: No — In order to protect the rights of our study participants, protected heath information will not be identified or shared.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Orlando Health, Inc.