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CompletedNCT02320929Updated Mar 30, 2025

The Treatment of Purulent Flexor Tenosynovitis

An interventional study of Intraoperative flexor tendon sheath irrigation and Postoperative flexor tendon sheath irrigation in Tenosynovitis, sponsored by Tampere University. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Tampere University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tenosynovitis

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Keywords

  • irrigation
  • tenosynovitis
  • purulent
  • closed-catheter
  • flexor tendon
03

In context

Tenosynovitis

17 studies on the registry are indexed under Tenosynovitis; 4 are open to participants now.

This study's planned enrollment of 48 is close to the median of 52 across 13 interventional studies indexed under Tenosynovitis.

Browse Tenosynovitis studies →

Lead sponsor

Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureIntraoperative flexor tendon sheath irrigation
  • ProcedurePostoperative flexor tendon sheath irrigation
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Need for reoperation

    Time frame: 3 months postoperatively

Other outcomes

  1. QuickDASH score

    Time frame: 4 weeks and 3 months postoperatively

  2. Pain at rest

    Pain at rest (Visual analog scale)

    Time frame: 4 weeks and 3 months postoperatively

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Study locations

1 site
  • Tampere University Hospital
    Tampere, Finland
08

References and documents

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. PubMed 26671952 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02320929
Lead sponsor
Tampere University
Responsible party
Olli Leppänen (Researcher, M.D., Ph.D., Tampere University) — Principal investigator
First posted
Dec 19, 2014
Start date
Mar 2015
Primary completion
Dec 2024
Completion
Dec 2024
Last update
Mar 30, 2025

Study contacts

Harry Göransson, M.D., Ph.D.
study chair · Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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