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

• ClinicalTrials.gov Identifier: NCT01022242
• Recruitment Status: Completed
• First Posted: December 1, 2009
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Sponsor: Pergamum AB
• Information provided by (Responsible Party): Pergamum AB

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Surgical Adhesions	Drug: PXL01; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery
• Study Start Date: December 2009
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. TAM2 [ Time Frame: At 12 weeks after surgery ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wiig ME, Dahlin LB, Fridén J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.

• Responsible Party: Pergamum AB
• ClinicalTrials.gov Identifier: NCT01022242
• Other Study ID Numbers: PHSU02
• First Posted: December 1, 2009
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Last Verified: April 2014

Keywords provided by Pergamum AB:

Surgical Adhesions; Post-surgical adhesions; Flexor tendon

Additional relevant MeSH terms:

Tissue Adhesions; Cicatrix; Fibrosis; Pathologic Processes