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

NCT ID: NCT01022242

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Surgical Adhesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is a physiological sodium chloride solution, which is clear and colourless.

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.

Group Type: EXPERIMENTAL

PXL01

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo is a physiological sodium chloride solution, which is clear and colourless.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pergamum AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Wiig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Hand Surgery Uppsala University Hospital

Locations

Dept. of Hand Surgery, Aalborg Hospital

Aalborg, , Denmark

Dept. of Hand Surgery, Odense University Hospital

Odense, , Denmark

Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH

Bad Neustadt an der Saale, , Germany

Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie

Duisburg, , Germany

St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie

Essen, , Germany

Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie

Homburg, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte

Lübeck, , Germany

Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt

Munich, , Germany

Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern

Munich, , Germany

Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH

Stuttgart, , Germany

Dept. of Hand Surgery Sahlgrenska University Hospital

Gothenburg, , Sweden

Dept. of Hand Surgery Malmö University Hospital

Malmo, , Sweden

Dept. of Hand Surgery, Stockholm South General Hospital

Stockholm, , Sweden

Dept. of Hand Surgery Uppsala University Hospital, entrance 70

Uppsala, , Sweden

Countries

Denmark; Germany; Sweden

References

Wiig ME, Dahlin LB, Friden 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.

Reference Type: DERIVED

PMID: 25340801 (View on PubMed)

Other Identifiers

PHSU02

Identifier Type: -

Identifier Source: org_study_id