Patient Satisfaction, Suture, Complication
Conditions
Keywords
suture, vessel loop, suture removal, satisfaction, carpal tunnel release
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.
Interventions
DEVICEVessel loop (FDA product code FZZ)
The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with suture removal | First postoperative visit (1-2 weeks) | This will be measured on a 100mm visual analog scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain with suture removal | First postoperative visit (1-2 weeks). | This will be measured on a 100mm visual analog scale. |
| Time to close the surgical wound | Intraoperatively (0 days) | The time that it takes the provider to close the wound intraoperatively. |
| Time to remove suture | First postoperative visit (1-2 weeks). | The time that it takes the provider to remove sutures postoperatively. |
| Wound complications | 6 weeks postoperatively | Any wound complications will be noted from the clinical record. |
| QuickDASH | 6 weeks postoperatively. | A validate instrument assessing disability of the arm, shoulder, and hand. |
Countries
United States
Outcome results
None listed