Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2009-09-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Active - Adaprev
Adaprev (Class III medical device)
Adaprev
Class III Medical Device
Standard Care
No different treatment to normal
No interventions assigned to this group
Interventions
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Adaprev
Class III Medical Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
* Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
* Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
* Subjects with conditions which may delay healing.
* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Females who are pregnant
18 Years
ALL
No
Sponsors
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Renovo
INDUSTRY
Responsible Party
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Renovo
Principal Investigators
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John Hutchison, MBBS PhD
Role: STUDY_DIRECTOR
Renovo Ltd
Locations
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Mr P Gillespie
Addenbrooke's Hospital, Cambridge, Cambridge, United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Mr F Schreuder
The Lister Hospital, Stevenage, Hertfordshire, United Kingdom
Royal London Hospital, Barts and The London Hospital
London, London, United Kingdom
Royal Free Hospital
London, London, United Kingdom
Chelsea & Westminster Hospital
London, London, United Kingdom
Mr R Dunn
Salisbury District Hospital, Salisbury, United Kingdom
Mr D Warwick
Southampton General Hospital, Southampton, United Kingdom
Abertawe Bro Morgannwg University Nhs Trust
Swansea, , United Kingdom
Countries
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Facility Contacts
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Patrick Gillespie
Role: primary
Miss V C Lees
Role: primary
Mr Schreuder
Role: primary
Kamal El-Ali
Role: primary
Donald Dewar
Role: primary
Mr Chakrabarty
Role: primary
Beryl De Souza
Role: backup
Roderick Dunn
Role: primary
David Warwick
Role: primary
Elaine Hayward
Role: backup
Mr D Boyce
Role: primary
Other Identifiers
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RN1008-0083
Identifier Type: -
Identifier Source: org_study_id