Table 1

Items from the clinical trials.gov data set

Data categoryInformation
Primary registry and trial identifying numberClinicalTrials.gov
NCT02320929
Date of registration in primary registry8 December 2014
Date and version identifier29 August 2015, v.1.0
Source(s) of monetary or material support–
Primary sponsorTampere University Hospital
Teiskontie 35
33520 Tampere
Finland
Secondary sponsorUniversity of Tampere
Contact for public queriesOlli V Leppänen, email: olli.v.leppanen@uta.fi, Tel.: +358-3-31167745
Contact for scientific queriesOlli V Leppänen, email: olli.v.leppanen@uta.fi, Tel.: +358-3-31167745
Public titleThe treatment of purulent flexor tenosynovitis—is postoperative catheter irrigation necessary?
Scientific titleAn investigator-blinded, randomised, 3 months, 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
Countries of recruitmentFinland
Health condition(s) or problem(s) studiedPurulent flexor tenosynovitis
Intervention(s)Intraoperative tendon sheath irrigation; intraoperative and postoperative tendon sheath irrigation
Key inclusion and exclusion criteriaAges eligible for study: ≥18 years
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria: clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel signs
Exclusion criteria: high-pressure, foreign body or chemical injuries that require open debridement; being a prisoner or military serviceman, being mentally retarded or having other factors that may affect decision-making
Study typeInterventional
Allocation: randomised
Intervention model: parallel assignment
Masking: single blind (investigator, outcomes assessor)
Primary purpose: treatment
Date of first enrolmentMarch 2015
Target sample size48
Recruitment statusRecruiting
Primary outcome(s)Total range of movement of the affected finger (time frame: 3 months; not designated as safety issue)
Key secondary outcomesNeed for reoperation (time frame: 3 months; not designated as safety issue); QuickDASH (time frame: 3 months; not designated as safety issue); pain at rest (time frame: 3 months; not designated as safety issue)

  • QuickDASH, Quick Disabilities of the Arm, Shoulder and Hand Score.