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A preliminary analysis was performed in this study halfway through enrollment and significant results were found, therefore the study was stopped.
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This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.
Surgical wound closure with nonabsorbable stitches necessitates subsequent suture removal, a process that can be uncomfortable for the patient and consume clinic time and resources. Anecdotal evidence suggests that the addition of a vessel loop under the sutures both simplifies suture removal and reduces discomfort. In this study, we propose a prospective, randomized, controlled, superiority trial to assess the impact of a vessel loop wound closure and suture removal for elective carpal tunnel release (CTR). Patients will be prospectively enrolled to one of two groups: closure without a vessel loop or closure with a vessel loop. The primary outcome measure will be patient satisfaction with suture removal. Time for wound closure, time for suture removal, pain with suture removal and other patient reported outcomes will be measured. These data will allow us to determine the benefit of addition of a vessel loop in wound closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closure without vessel loop | No Intervention | These patients will receive standard of care closure of the carpal tunnel release incision. | |
| Closure with vessel loop | Experimental | These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vessel loop (FDA product code FZZ) | Device | The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with suture removal | This will be measured on a 100mm visual analog scale. | First postoperative visit (1-2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain with suture removal | This will be measured on a 100mm visual analog scale. | First postoperative visit (1-2 weeks). |
| Time to close the surgical wound | The time that it takes the provider to close the wound intraoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Apel, MD, PhD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Institute for Orthopaedics & Neurosciences | Roanoke | Virginia | 24014 | United States |
No IPD are to be shared with other researchers. Only aggregate data will be shared.
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Patients who agree to participate will be enrolled and randomized to one of two study groups:
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| Intraoperatively (0 days) |
| Time to remove suture | The time that it takes the provider to remove sutures postoperatively. | First postoperative visit (1-2 weeks). |
| Wound complications | Any wound complications will be noted from the clinical record. | 6 weeks postoperatively |
| QuickDASH | A validate instrument assessing disability of the arm, shoulder, and hand. | 6 weeks postoperatively. |