Clinical trial NCT01022242: Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Official title: A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Adhesions
Keywords: Surgical Adhesions
Post-surgical adhesions
Flexor tendon
Lead sponsor: Pergamum AB
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 138
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: TAM2
timeFrame: At 12 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of Hand Surgery, Aalborg Hospital
city: Odense
country: Denmark
facility: Dept. of Hand Surgery, Odense University Hospital
city: Bad Neustadt
country: Germany
facility: Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH
city: Duisburg
country: Germany
facility: Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie
city: Essen
country: Germany
facility: St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie
city: Hannover
country: Germany
facility: Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte
city: Munich
country: Germany
facility: Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
city: Munich
country: Germany
facility: Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern
city: Stuttgart
country: Germany
facility: Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
city: Gothenburg
country: Sweden
facility: Dept. of Hand Surgery Sahlgrenska University Hospital
city: Malmö
country: Sweden
facility: Dept. of Hand Surgery Malmö University Hospital
city: Stockholm
country: Sweden
facility: Dept. of Hand Surgery, Stockholm South General Hospital
city: Uppsala
country: Sweden
facility: Dept. of Hand Surgery Uppsala University Hospital, entrance 70
Study officials:
affiliation: Dept. of Hand Surgery Uppsala University Hospital
name: Monica Wiig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.