Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery (PHSU02)

Pergamum AB

Status and phase: Completed; Phase 2

Conditions: Surgical Adhesions

Treatments: Drug: PXL01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022242

PHSU02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

PXL01

Experimental group

Description:

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.

Treatment:

Drug: PXL01