The Treatment of Purulent Flexor Tenosynovitis

Not Applicable

Recruiting

• Conditions: Tenosynovitis
• Interventions: Procedure: Intraoperative flexor tendon sheath irrigation; Procedure: Postoperative flexor tendon sheath irrigation

• Registration Number: NCT02320929
• Lead Sponsor: Tampere University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Study Start: 2015-03
• Status Verified: 2023-11
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative irrigation only	Intraoperative flexor tendon sheath irrigation	The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions.
Intra- and postoperative irrigation	Intraoperative flexor tendon sheath irrigation	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.
Intra- and postoperative irrigation	Postoperative flexor tendon sheath irrigation	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.

Primary Outcome Measures

Name	Time	Method
Active range of movement of the most affected finger	3 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Need for reoperation	3 months postoperatively

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland