SENSE: abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
Study Details
Study Description
Brief Summary
Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Carpal Tunnel Syndrome is a prevalent condition; up to 9% in women and 0.6% in men. It causes complaints of paresthesia, pain, numbness and loss of strength. Surgical decompression is the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of suture material which is used can influence the prevalence of wound infection. In current clinical practice both absorbable and non absorbable sutures are used. In literature, various hypothesis are described: Absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. This would not be the case for non-absorbable sutures, since they will be removed. However, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.
The primary outcome is the ASEPSIS wound score. This will be scored by independent investigators.
Use of antibiotics, handtherapy and extra outpatient visits will be recorded.
Patients are asked to register their NRS scores the first three weeks after surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Absorbable sutures Absorbable sutures Vicryl rapide or Safil quick |
Procedure: Carpal Tunnel Release
Transection of flexor retinaculum for patients who have carpal tunnel syndrome
|
| Active Comparator: Non-absorbable sutures Non-absorbable sutures Ethilon or Flexocrin |
Procedure: Carpal Tunnel Release
Transection of flexor retinaculum for patients who have carpal tunnel syndrome
|
Outcome Measures
Primary Outcome Measures
- ASEPSIS wound score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days) [10 to 14 days post surgery]
score based on a picture made of the wound 10-14 days post carpal tunnel release. Minimum score 0, maximum score 70, score above 40 is categorized as wound infection
Secondary Outcome Measures
- NRS score (Numeric Rating Scale for pain) [until three weeks post surgery]
pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0.
Eligibility Criteria
Criteria
Inclusion Criteria:
• indication for carpal tunnel release
Exclusion Criteria:
-
carpal tunnel syndrome which has yet been operated
-
injection with corticosteroids
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gelre Ziekenhuizen | Apeldoorn | Netherlands | 7334DZ | |
| 2 | Deventer Ziekenhuis | Deventer | Netherlands | 7416SE |
Sponsors and Collaborators
- Gelre Hospitals
- Deventer Ziekenhuis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/551