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Completed

NCT Number: NCT02320929

The Treatment of Purulent Flexor Tenosynovitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative flexor tendon sheath irrigation

Procedure

Postoperative flexor tendon sheath irrigation

Procedure

Primary outcomes

  1. 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.

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

    Time frame: 4 weeks and 3 months postoperatively

    Pain at rest (Visual analog scale)

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2014
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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