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

Study Overview
=================
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.

Official Title
-----------------
A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery

Conditions
-----------------
Surgical Adhesions

Intervention / Treatment
-----------------
* Drug: PXL01
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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 Open flexor tendon injury sutured within 14 days after trauma 12-75 years of age Signed informed consent prior to any study related procedures Exclusion criteria Treatment with any investigational product within 4 weeks of study entry Patients previously included in the study Thumbs with complete or partial division of flexor pollicis longus (FPL) Concomitant fracture(s) requiring immobilisation Injuries with associated soft tissue loss Severe crush injury Palmar plate injury requiring immobilisation Devascularisation/requirement of vascular repair Joint injuries Bilateral injuries Previous flexor tendon surgery in the digit, which is to be treated with IMP Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury Compliance with mobilisation protocol not expected Alcohol or drug abuse 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 Pregnant or lactating females 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. Known allergy to any component of the study product or placebo Patients suffering from: Diabetes Mellitus patients where significant diabetic complications may delay healing according to the investigator's judgement Rheumatoid arthritis 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Placebo is a physiological sodium chloride solution, which is clear and colourless.<br>|
| Experimental: PXL01<br>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. | Drug: PXL01<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 12 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Adhesions, Post-surgical adhesions, Flexor tendon