ClinicalTrials.gov
ClinicalTrials.gov Menu

The Treatment of Purulent Flexor Tenosynovitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02320929
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Olli Leppänen, University of Tampere

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.

Condition or disease Intervention/treatment Phase
Tenosynovitis Procedure: Intraoperative flexor tendon sheath irrigation Procedure: Postoperative flexor tendon sheath irrigation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Purulent Flexor Tenosynovitis - Is Postoperative Catheter Irrigation Necessary? A Prospective Randomized Trial.
Actual Study Start Date : March 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Need for reoperation [ Time Frame: 3 months postoperatively ]

Other Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320929


Contacts
Contact: Olli V. Leppänen, M.D., Ph.D. +358-3-31167745 olli.leppanen@fimnet.fi
Contact: Jarkko Jokihaara, M.D., Ph.D. +358-3-31165927 jarkko.jokihaara@gmail.com

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Olli V. Leppänen, M.D., Ph.D.    +358-3-31167745    olli.leppanen@fimnet.fi   
Sponsors and Collaborators
University of Tampere
Tampere University Hospital
Investigators
Study Chair: Harry Göransson, M.D., Ph.D. Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Olli Leppänen, Researcher, M.D., Ph.D., University of Tampere
ClinicalTrials.gov Identifier: NCT02320929     History of Changes
Other Study ID Numbers: R14153
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Olli Leppänen, University of Tampere:
irrigation
tenosynovitis
purulent
closed-catheter
flexor tendon

Additional relevant MeSH terms:
Tenosynovitis
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases