The Treatment of Purulent Flexor Tenosynovitis
Primary Purpose
Tenosynovitis
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intraoperative flexor tendon sheath irrigation
Postoperative flexor tendon sheath irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Tenosynovitis focused on measuring irrigation, tenosynovitis, purulent, closed-catheter, flexor tendon
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
Sites / Locations
- Tampere University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intraoperative irrigation only
Intra- and postoperative irrigation
Arm Description
The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Need for reoperation
Full Information
NCT ID
NCT02320929
First Posted
December 8, 2014
Last Updated
May 17, 2022
Sponsor
Tampere University
Collaborators
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02320929
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tenosynovitis
Keywords
irrigation, tenosynovitis, purulent, closed-catheter, flexor tendon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative irrigation only
Arm Type
Experimental
Arm Description
The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions.
Arm Title
Intra- and postoperative irrigation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative flexor tendon sheath irrigation
Intervention Type
Procedure
Intervention Name(s)
Postoperative flexor tendon sheath irrigation
Primary Outcome Measure Information:
Title
Active range of movement of the most affected finger
Description
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 Outcome Measure Information:
Title
Need for reoperation
Time Frame
3 months postoperatively
Other Pre-specified Outcome Measures:
Title
QuickDASH score
Time Frame
4 weeks and 3 months postoperatively
Title
Pain at rest
Description
Pain at rest (Visual analog scale)
Time Frame
4 weeks and 3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olli V. Leppänen, M.D., Ph.D.
Phone
+358-3-31167745
Email
olli.leppanen@fimnet.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jarkko Jokihaara, M.D., Ph.D.
Phone
+358-3-31165927
Email
jarkko.jokihaara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Göransson, M.D., Ph.D.
Organizational Affiliation
Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olli V. Leppänen, M.D., Ph.D.
Phone
+358-3-31167745
Email
olli.leppanen@fimnet.fi
12. IPD Sharing Statement
Citations:
PubMed Identifier
26671952
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.
Results Reference
derived
Learn more about this trial
The Treatment of Purulent Flexor Tenosynovitis
We'll reach out to this number within 24 hrs