Surgical Adhesions
Conditions
Keywords
Surgical Adhesions, Post-surgical adhesions, Flexor tendon
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.
Interventions
DRUGPXL01
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.
DRUGPlacebo
Placebo is a physiological sodium chloride solution, which is clear and colourless.
Sponsors
Pergamum AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TAM2 | At 12 weeks after surgery | 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. |
Countries
Denmark, Germany, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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.
Placebo is a physiological sodium chloride solution, which is clear and colourless. | 70 |
| PXL01 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.
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. | 65 |
| Total | 135 |
Baseline characteristics
| Characteristic | Placebo | PXL01 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 60 Participants | 126 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 64 Participants | 62 Participants | 126 Participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 51 Participants | 48 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 70 | 22 / 65 |
| serious Total, serious adverse events | 9 / 70 | 10 / 65 |
Outcome results
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.
Time frame: At 12 weeks after surgery
Population: FAS population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | TAM2 | 108 Degrees |
| PXL01 | TAM2 | 121 Degrees |
p-value: 0.8861ANCOVA