The Treatment of Purulent Flexor Tenosynovitis

Study Overview
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Brief Summary
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This study evaluates the effect of postoperative intermittent closed-catheter irrigation on the recovery from the purulent flexor tenosynovitis. One group of patients suffering from acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the other group having both intra- and postoperative irrigation.

Detailed Description
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The foundation of the successful management of purulent flexor tenosynovitis is the surgical debridement followed by an intravenous antibiotic treatment. Several surgical methods have been described to remove the purulent debris from the flexor tendon sheath. Closed-catheter irrigation involves irrigation of the tendon sheath from proximal to distal direction facilitated by two small incisions; one proximal to A1 pulley and one distal to A4 pulley. Lille et al. (J Hand Surg Br. 2000;25(3):304-307) conducted a retrospective study that implied that intraoperative closed-catheter irrigation without postoperative irrigation might be as effective as the combination of intra- and postoperative irrigation. The hypothesis of this prospective randomized trial is that the intraoperative closed-catheter irrigation alone is as effective as the combination of intraoperative and postoperative intermittent closed-catheter irrigation in the treatment of purulent flexor tenosynovitis.

Official Title
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The Treatment of Purulent Flexor Tenosynovitis - Is Postoperative Catheter Irrigation Necessary? A Prospective Randomized Trial.

Conditions
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Tenosynovitis

Intervention / Treatment
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* Procedure: Intraoperative flexor tendon sheath irrigation
* Procedure: Postoperative flexor tendon sheath irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel's signs: symmetric swelling of the entire digit exquisite tenderness along the course of the tendon sheath semiflexed posture of the digit pain with attempted passive extension of the digit age over 18 years patient's willingness to participate in the study Exclusion Criteria: High-pressure, foreign body or chemical injuries, which require open debridement prisoner, military serviceman, mental retardation or other factors which may affect one's decision making

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative irrigation only<br>The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions. | Procedure: Intraoperative flexor tendon sheath irrigation<br> <br> |
| Active Comparator: Intra- and postoperative irrigation<br>The infected tendon sheath is irrigated intraoperatively, the catheter is kept in place, the irrigation is continued postoperatively 3 times a day for 3 days. | Procedure: Intraoperative flexor tendon sheath irrigation<br> <br> Procedure: Postoperative flexor tendon sheath irrigation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active range of movement of the most affected finger | The total active range of movement is calculated as: (active flexion of MCPJ + PIPJ + DIPJ) - (extension deficit of MCPJ + PIPJ + DIPJ). MCPJ, metacarpophalangeal joint; PIPJ, proximal interphalangeal joint; DIPJ, distal interphalangeal joint. | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for reoperation |  | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irrigation, tenosynovitis, purulent, closed-catheter, flexor tendon