Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery (PHSU02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pergamum AB
ClinicalTrials.gov Identifier:
NCT01022242
First received: November 25, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Surgical Adhesions
Drug: PXL01
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Pergamum AB:

Primary Outcome Measures:
  • TAM2 [ Time Frame: At 12 weeks after surgery ] [ Designated as safety issue: No ]
    The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.


Enrollment: 138
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Placebo is a physiological sodium chloride solution, which is clear and colourless.
Experimental: PXL01
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.
Drug: PXL01
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.

Detailed Description:

This is a multi-centre, randomized, double 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), tip-to-crease, 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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Complete division of flexor digitorium profundus tendon (FDP) in zone I or II, with or without division of flexor digitorium superficialis (FDS) and possible to rejoin with tendon suture
  2. Open flexor tendon injury sutured within 14 days after trauma
  3. 12-75 years of age
  4. Signed informed consent prior to any study related procedures

Exclusion criteria

  1. Treatment with any investigational product within 4 weeks of study entry
  2. Patients previously included in the study
  3. Thumbs with complete or partial division of flexor pollicis longus (FPL)
  4. Concomitant fracture(s) requiring immobilisation
  5. Injuries with associated soft tissue loss
  6. Severe crush injury
  7. Palmar plate injury requiring immobilisation
  8. Devascularisation/requirement of vascular repair
  9. Joint injuries
  10. Bilateral injuries
  11. Previous flexor tendon surgery in the digit, which is to be treated with IMP
  12. Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
  13. Compliance with mobilisation protocol not expected
  14. Alcohol or drug abuse
  15. Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
  16. Pregnant or lactating females
  17. Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
  18. Known allergy to any component of the study product or placebo
  19. Patients suffering from:

    • Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator's judgement
    • Rheumatoid arthritis
  20. Or patients treated with:

    • Systemic steroids within one month
    • Immunosuppressive drugs within three months
    • Daily use of NSAIDs within one week or occasional use within 8 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022242

Locations
Denmark
Dept. of Hand Surgery, Aalborg Hospital
Aalborg, Denmark, 9000
Dept. of Hand Surgery, Odense University Hospital
Odense, Denmark, 5000
Germany
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 Großhadern
Munich, Germany, 81377
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
Munich, Germany, 80336
Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
Stuttgart, Germany, 70199
Sweden
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
Sponsors and Collaborators
Pergamum AB
Investigators
Principal Investigator: Monica Wiig, MD, PhD Dept. of Hand Surgery Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Pergamum AB
ClinicalTrials.gov Identifier: NCT01022242     History of Changes
Other Study ID Numbers: PHSU02
Study First Received: November 25, 2009
Results First Received: February 4, 2014
Last Updated: April 30, 2014
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Madicines Agency
Germany: BfArm

Keywords provided by Pergamum AB:
Surgical Adhesions
Post-surgical adhesions
Flexor tendon

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014