Clinical trial NCT02320929: The Treatment of Purulent Flexor Tenosynovitis
Official title: The Treatment of Purulent Flexor Tenosynovitis - is Postoperative Catheter Irrigation Necessary? a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tenosynovitis
Keywords: irrigation
tenosynovitis
purulent
closed-catheter
flexor tendon
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2014-12-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Active range of movement of the most affected finger
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Need for reoperation
timeFrame: 3 months postoperatively
Other outcomes:
measure: QuickDASH score
timeFrame: 4 weeks and 3 months postoperatively
measure: Pain at rest
timeFrame: 4 weeks and 3 months postoperatively
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital
name: Harry Göransson, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.