Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery (PHSU02)
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery|
- The primary variable is Total Active Motion (TAM) at the proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints (i.e. TAM2) of the affected digit at actively made fist at 12 weeks after surgery. [ Time Frame: from administration until 12 months after. ] [ Designated as safety issue: No ]
- The secondary objectives are to evaluate additional efficacy variables and safety, including rupture rate, of a single local administration of PXL01 in sodium hyaluronate in patients with a flexor tendon injury in zone I or II. [ Time Frame: from administration until 12 months after. ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||February 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
Placebo is a physiological sodium chloride solution, which is clear and colourless.
PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
This is a multi-centre, randomized, single-blind, parallel study design in patient admitted for flexor tendon repair in zone II.
The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.
Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), grip strength and Total Passive Motion (TPM2 and TPM3).
Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.
|Dept. of Hand Surgery, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Dept. of Hand Surgery, Odense University Hospital|
|Odense, Denmark, 5000|
|Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH|
|Bad Neustadt, Germany, 97616|
|Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie|
|Duisburg, Germany, 47166|
|St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie|
|Essen, Germany, 45257|
|Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie|
|Homburg, Germany, 66421|
|Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte|
|Lübeck, Germany, 23538|
|Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt|
|Munich, Germany, 80336|
|Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern|
|Munich, Germany, 81377|
|Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH|
|Stuttgart, Germany, 70199|
|Dept. of Hand Surgery Sahlgrenska University Hospital|
|Gothenburg, Sweden, SE-413 45|
|Dept. of Hand Surgery Malmö University Hospital|
|Malmö, Sweden, SE-20502|
|Dept. of Hand Surgery, Stockholm South General Hospital|
|Stockholm, Sweden, 118 83|
|Dept. of Hand Surgery Uppsala University Hospital, entrance 70|
|Uppsala, Sweden, SE-75185|
|Principal Investigator:||Monica Wiig, MD, PhD||Dept. of Hand Surgery Uppsala University Hospital|