Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Condition: Surgical Adhesions
MeSH terms: Tissue Adhesions
Intervention: PXL01; Placebo
Intervention description: 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 is a physiological sodium chloride solution, which is clear and colourless.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Surgical Adhesions; Post-surgical adhesions; Flexor tendon

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.
    

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