Clinical trial NCT04339439: Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
Official title: Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patient Satisfaction
Suture, Complication
Keywords: suture
vessel loop
suture removal
satisfaction
carpal tunnel release
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction with suture removal
timeFrame: First postoperative visit (1-2 weeks)
Secondary outcomes:
measure: Pain with suture removal
timeFrame: First postoperative visit (1-2 weeks).
measure: Time to close the surgical wound
timeFrame: Intraoperatively (0 days)
measure: Time to remove suture
timeFrame: First postoperative visit (1-2 weeks).
measure: Wound complications
timeFrame: 6 weeks postoperatively
measure: QuickDASH
timeFrame: 6 weeks postoperatively.
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Institute for Orthopaedics & Neurosciences
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Peter J Apel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: