Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576869
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Timing of Tourniquet Release A Prospective Randomized Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Timing Of Tourniquet Release A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
This includes typedose of medication
Duration for taking the medication
Was the medication halted prior to surgery if so when
Surgeon performing the surgery
Surgical procedure
Surgery location ACC ORMC etc
When tourniquet is dropped beforeafter 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 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
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
This includes typedose of medication
Duration for taking the medication
Was the medication halted prior to surgery if so when
Surgeon performing the surgery
Surgical procedure
Surgery location ACC ORMC etc
When tourniquet is dropped beforeafter 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None