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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pergamum AB

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