The Treatment of Purulent Flexor Tenosynovitis

November 28, 2023 updated by: Olli Leppänen, Tampere University

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for reoperation
Time Frame: 3 months postoperatively
3 months postoperatively

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R14153

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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