Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Carilion Clinic
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Patient satisfaction with suture removal
Study Overview
Brief Summary
This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Closure without vessel loop
These patients will receive standard of care closure of the carpal tunnel release incision.
Closure with vessel loop
These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures.
Intervention: Vessel loop (FDA product code FZZ) (Device)
Outcomes
Primary Outcomes
Patient satisfaction with suture removal
Time Frame: First postoperative visit (1-2 weeks)
This will be measured on a 100mm visual analog scale.
Secondary Outcomes
- Pain with suture removal(First postoperative visit (1-2 weeks).)
- Time to close the surgical wound(Intraoperatively (0 days))
- Time to remove suture(First postoperative visit (1-2 weeks).)
- QuickDASH(6 weeks postoperatively.)
- Wound complications(6 weeks postoperatively)