Carpal Tunnel Syndrome, Median Nerve Entrapment
Conditions
Keywords
carpal tunnel, carpal tunnel syndrome, median nerve release, median nerve entrapment, surgery, suture, absorbable, non-absorbable
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.
Interventions
PROCEDURESurgical wound closed with an absorbable suture
Patients undergoing median nerve release surgery will get their surgical wound closed with an absorbable suture according to their respective study group.
PROCEDURESurgical wound closed with a non-absorbable suture
Patients undergoing median nerve release surgery will get their surgical wound closed with a non-absorbable suture according to their respective study group.
Sponsors
University of Eastern Finland
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* carpal tunnel syndrome diagnosed with electro near my-graphs * symptoms typical of carpal tunnel syndrome * referral to carpal tunnel release * informed consent signed * the ability to receive the virtual questionnaire via email and answer it * the ability to understand and answer the Finnish questionnaires
Exclusion criteria
* repeat surgery * known allergy to suture materials * ongoing systemic steroid treatment * ongoing chemotherapy * ongoing immunomodulatory treatment * past hypertrophic or keloid scars or other severe disturbances in wound healing * age under 18, pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Finland
Outcome results
None listed