Patient SatisfactionNCT04339439
Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
A study testing Vessel loop (FDA product code FZZ) in people with Patient Satisfaction and Suture, Complication, run by Carilion Clinic at 1 site in United States.
Trial summary
This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Patient Satisfaction, Suture, Complication
- What is being tested?
- Vessel loop (FDA product code FZZ)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Institute for Orthopaedics & Neurosciences
Roanoke, Virginia, 24014
About this study
This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.
Read the 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.
- Conditions
- Patient Satisfaction, Suture, Complication
- Being tested
- Vessel loop (FDA product code FZZ)
- Keywords
- suture, vessel loop, suture removal, satisfaction, carpal tunnel release
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vessel loop (FDA product code FZZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with suture removal
This will be measured on a 100mm visual analog scale.
Measured: First postoperative visit (1-2 weeks)
Secondary outcomes (5)
Pain with suture removal
This will be measured on a 100mm visual analog scale.
Measured: First postoperative visit (1-2 weeks).
Time to close the surgical wound
The time that it takes the provider to close the wound intraoperatively.
Measured: Intraoperatively (0 days)
Time to remove suture
The time that it takes the provider to remove sutures postoperatively.
Measured: First postoperative visit (1-2 weeks).
Wound complications
Any wound complications will be noted from the clinical record.
Measured: 6 weeks postoperatively
QuickDASH
A validate instrument assessing disability of the arm, shoulder, and hand.
Measured: 6 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Aug 2020
- Primary completion23 Nov 2021
- Study completion19 Jul 2022
Why it stopped: A preliminary analysis was performed in this study halfway through enrollment and significant results were found, therefore the study was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Apel, MD, PhD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339439
- Sponsor's protocol ID
- IRB-20-737
- Status last verified
- Feb 2023
- First submitted
- 6 Apr 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are to be shared with other researchers. Only aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
- ClinicalTrials.gov ID
- NCT04339439
- Acronym / sponsor ID
- IRB-20-737
- Conditions
- Patient Satisfaction, Suture, Complication
- Keywords
- suture, vessel loop, suture removal, satisfaction, carpal tunnel release
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A preliminary analysis was performed in this study halfway through enrollment and significant results were found, therefore the study was stopped.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Vessel loop (FDA product code FZZ)These patients will receive closure of the carpal tunnel release incision with a vessel loop placed under the sutures. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS).
Key exclusion criteria (8 listed)
- Emergency procedures.
- Revision procedures.
- Bilateral procedures.
- Concomitant procedures.
- Inability to provide informed consent for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vessel 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. | Device | Closure with vessel loop |
Primary outcome
Patient satisfaction with suture removal
Time frame: First postoperative visit (1-2 weeks)
This will be measured on a 100mm visual analog scale.
5 secondary outcomes
Pain with suture removal
Time frame: First postoperative visit (1-2 weeks).
Time to close the surgical wound
Time frame: Intraoperatively (0 days)
Time to remove suture
Time frame: First postoperative visit (1-2 weeks).
Wound complications
Time frame: 6 weeks postoperatively
QuickDASH
Time frame: 6 weeks postoperatively.
Results and safety
The study was stopped early (reason given: A preliminary analysis was performed in this study halfway through enrollment and significant results were found, therefore the study was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No. No IPD are to be shared with other researchers. Only aggregate data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Apel, MD, PhD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vessel loop (FDA product code FZZ) in people with Patient Satisfaction and Suture, Complication, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A preliminary analysis was performed in this study halfway through enrollment and significant results were found, therefore the study was stopped.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with suture removal (time frame: First postoperative visit (1-2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.