An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome; Median Nerve Entrapment

• Registration Number: NCT05503719
• Lead Sponsor: Kuopio University Hospital

Brief Summary

The study compares two widely used treatments in closing the wound after open carpal tunnel release surgery: absorbable and non-absorbable sutures. It is conducted as a randomized controlled trial, where the participants are divided into two research groups. The visual outcome of the scar will be evaluated a year after the surgery.

Detailed Description

Absorbable sutures are more cost efficient and eliminate the need for suture removal both reducing costs and abolishing suture removal pain. We will study the difference in the visual outcome between the two groups. Based on former study the primary hypothesis is that there is no difference between the groups. The patients will evaluate their scars on a VAS-scale one year after the surgery. Secondarily we will focus on pain caused by the two sutures and take the suture removal pain into consideration. We expect therefore the non-absorbable suture to cause more pain in total. The evaluation will happen 2 weeks after the surgery by the patients.

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-09-21
• Status Verified: 2023-09
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient	1 year	The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "the ugliest scar possible" to "the most beautiful scar possible". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 year	Adverse events will be monitored throughout the trial, and patients will be instructed to promptly report any potential serious adverse events. At the one-year follow-up point, the questionnaires will include an inquiry about whether the patient has experienced any adverse events.
The Net Promoter Score	1 year	Client experience, the likelihood of the patient to recommend the operation to a friend or a colleague
Costs	1 year	The mean difference between the two study arms in treatment costs.The required data will be analysed from the trial data and Finnish healthcare registries.
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor	1 year	The subjective aesthetics of the scar evaluated by an outcome assessor on a 10 cm visual analog scale (VAS) ranging from "the ugliest scar possible" to "the most beautiful scar possible". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.
Pain (VAS) experienced by the patient from the sutures	2 weeks	The rate of any the pain in the area of the scar including pain related to possible suture removal evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "no pain at all" to "worst pain imaginable". Propotions of patients in ten groups from 0 to 10 will be reported. Outcome will be collected at two weeks time point.
The Boston Carpal Tunnel Questionnaire	1 year	A disease-specific measure of self-reported symptom severity and functional status measuring the effectiveness of the treatment. Outcome will be collected preoperatively and at one year time point.

Trial Locations

Locations (1)

Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery; 🇫🇮 Kuopio, Pohjois-Savo, Finland