TenosynovitisNCT02320929
The Treatment of Purulent Flexor Tenosynovitis
A study testing Intraoperative flexor tendon sheath irrigation and Postoperative flexor tendon sheath irrigation in people with Tenosynovitis, run by Tampere University at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tenosynovitis
- What is being tested?
- Intraoperative flexor tendon sheath irrigation and Postoperative flexor tendon sheath irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2015to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Treatment of Purulent Flexor Tenosynovitis - is Postoperative Catheter Irrigation Necessary? a Prospective Randomized Trial.
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.
Read the 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.
- Conditions
- Tenosynovitis
- Being tested
- Intraoperative flexor tendon sheath irrigation, Postoperative flexor tendon sheath irrigation
- Keywords
- irrigation, tenosynovitis, purulent, closed-catheter, flexor tendon
- Medical subject headings
- Tenosynovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative flexor tendon sheath irrigationProcedure or surgery
Postoperative flexor tendon sheath irrigationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative irrigation only | Experimental | The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions. Receives: 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. Receives: Procedure: Intraoperative flexor tendon sheath irrigation; Procedure: Postoperative flexor tendon sheath irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postoperatively
Secondary outcomes (1)
Need for reoperation
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TenosynovitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Olli Leppänen, Tampere University
- Investigators
- Harry Göransson, M.D., Ph.D., Study chair, Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320929
- Sponsor's protocol ID
- R14153
- Status last verified
- Mar 2025
- First submitted
- 8 Dec 2014
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26671952
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Purulent Flexor Tenosynovitis - is Postoperative Catheter Irrigation Necessary? a Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT02320929
- Acronym / sponsor ID
- R14153
- Conditions
- Tenosynovitis
- Keywords
- irrigation, tenosynovitis, purulent, closed-catheter, flexor tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative irrigation only | Experimental | Procedure: Intraoperative flexor tendon sheath irrigationThe infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions. |
| Intra- and postoperative irrigation | Active comparator | Procedure: Intraoperative flexor tendon sheath irrigation, Procedure: Postoperative flexor tendon sheath irrigationThe infected tendon sheath is irrigated intraoperatively, the catheter is kept in place, the irrigation is continued postoperatively 3 times a day for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel's signs:
- age over 18 years
- patient's willingness to participate in the study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative flexor tendon sheath irrigation | Procedure or surgery | Intra- and postoperative irrigation, Intraoperative irrigation only |
| Postoperative flexor tendon sheath irrigation | Procedure or surgery | Intra- and postoperative irrigation |
Primary outcome
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.
1 secondary outcome
Need for reoperation
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 26671952Leppanen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Göransson, M.D., Ph.D. study chair
Chief surgeon, Department of Hand and Microsurgery, Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative flexor tendon sheath irrigation and Postoperative flexor tendon sheath irrigation in people with Tenosynovitis, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of movement of the most affected finger (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.