The Treatment of Purulent Flexor Tenosynovitis

The Treatment of Purulent Flexor Tenosynovitis - is Postoperative Catheter Irrigation Necessary? a Prospective Randomized Trial.

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.

Study Overview

• Status: Completed
• Conditions: Tenosynovitis
• Intervention / Treatment: Procedure: Intraoperative flexor tendon sheath irrigation; Procedure: Postoperative flexor tendon sheath 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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative irrigation only; 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
Active Comparator: Intra- and postoperative 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.	Procedure: Intraoperative flexor tendon sheath irrigation; Procedure: Postoperative flexor tendon sheath irrigation

What is the study measuring?

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	Time Frame
Need for reoperation	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QuickDASH score		4 weeks and 3 months postoperatively
Pain at rest	Pain at rest (Visual analog scale)	4 weeks and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Tampere University Hospital
• Investigators: Study Chair: Harry Göransson, M.D., Ph.D., Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital

Publications and helpful links

General Publications

• Leppanen OV, Jokihaara J, Kaivorinne A, Havulinna J, Goransson H. Protocol for an investigator-blinded, randomised, 3-month, parallel-group study to compare the efficacy of intraoperative tendon sheath irrigation only with both intraoperative and postoperative irrigation in the treatment of purulent flexor tenosynovitis. BMJ Open. 2015 Dec 15;5(12):e008824. doi: 10.1136/bmjopen-2015-008824.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimated): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: tenosynovitis; irrigation; purulent; closed-catheter; flexor tendon
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tenosynovitis
• Other Study ID Numbers: R14153