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| Name | Class |
|---|---|
| Deventer Ziekenhuis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable sutures | Active Comparator | Absorbable sutures Vicryl rapide or Safil quick |
|
| Non-absorbable sutures | Active Comparator | Non-absorbable sutures Ethilon or Flexocrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carpal Tunnel Release | Procedure | Transection of flexor retinaculum for patients who have carpal tunnel syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 10 to 14 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS score (Numeric Rating Scale for pain) | pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0. | until three weeks post surgery |
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Inclusion Criteria:
• indication for carpal tunnel release
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pauline Verhaegen, MD PHD | Contact | 0555811244 | paulineverhaegen@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre Ziekenhuizen | Recruiting | Apeldoorn | 7334DZ | Netherlands |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Deventer Ziekenhuis | Recruiting | Deventer | 7416SE | Netherlands |
|
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D007239 | Infections |