NCT02320929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

9.8 years

First QC Date

December 8, 2014

Last Update Submit

March 25, 2025

Conditions

Tenosynovitis

Keywords

irrigationtenosynovitispurulentclosed-catheterflexor tendon

Outcome Measures

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.

    3 months postoperatively

Secondary Outcomes (1)

  • Need for reoperation

    3 months postoperatively

Other Outcomes (2)

  • QuickDASH score

    4 weeks and 3 months postoperatively

  • Pain at rest

    4 weeks and 3 months postoperatively

Study Arms (2)

Intraoperative irrigation only

EXPERIMENTAL

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

Intra- and postoperative irrigation

ACTIVE COMPARATOR

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 irrigationProcedure: Postoperative flexor tendon sheath irrigation

Interventions

Intraoperative flexor tendon sheath irrigationPROCEDURE
Intra- and postoperative irrigationIntraoperative irrigation only
Postoperative flexor tendon sheath irrigationPROCEDURE
Intra- and postoperative irrigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • 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.

    PMID: 26671952DERIVED

MeSH Terms

Conditions

Tenosynovitis

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Harry Göransson, M.D., Ph.D.

    Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, M.D., Ph.D.

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 19, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

FI(1)