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

Surgical Adhesions Clinical Trial

— PHSU02  

Official title:

A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022242
• Other study ID #: PHSU02
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2009
• Last updated: April 30, 2014
• Start date: December 2009
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: Pergamum AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyDenmark: Danish Madicines AgencyGermany: BfArm
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Adhesions
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
Denmark	Dept. of Hand Surgery, Aalborg Hospital	Aalborg
Denmark	Dept. of Hand Surgery, Odense University Hospital	Odense
Germany	Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH	Bad Neustadt
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	Hannover
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 Großhadern	Munich
Germany	Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt	Munich
Germany	Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH	Stuttgart
Sweden	Dept. of Hand Surgery Sahlgrenska University Hospital	Gothenburg
Sweden	Dept. of Hand Surgery Malmö University Hospital	Malmö
Sweden	Dept. of Hand Surgery, Stockholm South General Hospital	Stockholm
Sweden	Dept. of Hand Surgery Uppsala University Hospital, entrance 70	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Pergamum AB

Countries where clinical trial is conducted

Denmark,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TAM2	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.	At 12 weeks after surgery	No