Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?

Conditions
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Patient Satisfaction, Suture, Complication

Intervention / Treatment
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* Device: Vessel loop (FDA product code FZZ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS). Exclusion Criteria: Emergency procedures. Revision procedures. Bilateral procedures. Concomitant procedures. Inability to provide informed consent for the study. Non-native English speakers. Allergy to suture material. History of wrist trauma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who agree to participate will be enrolled and randomized to one of two study groups: Group 1: Incision closure without a vessel loop. Group 2: Incision closure with a vessel loop.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Closure without vessel loop<br>These patients will receive standard of care closure of the carpal tunnel release incision. | |
| Experimental: Closure with vessel loop<br>These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures. | Device: Vessel loop (FDA product code FZZ)<br>* The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suture, vessel loop, suture removal, satisfaction, carpal tunnel release