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

Primary Purpose

Surgical Adhesions

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PXL01
Placebo
Sponsored by
Pergamum AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Adhesions focused on measuring Surgical Adhesions, Post-surgical adhesions, Flexor tendon

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Hand Surgery, Aalborg Hospital
  • Dept. of Hand Surgery, Odense University Hospital
  • Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH
  • Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie
  • St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie
  • Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover
  • Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte
  • Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
  • Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern
  • Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
  • Dept. of Hand Surgery Sahlgrenska University Hospital
  • Dept. of Hand Surgery Malmö University Hospital
  • Dept. of Hand Surgery, Stockholm South General Hospital
  • Dept. of Hand Surgery Uppsala University Hospital, entrance 70

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

PXL01

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2009
Last Updated
April 30, 2014
Sponsor
Pergamum AB
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1. Study Identification

Unique Protocol Identification Number
NCT01022242
Brief Title
Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery
Acronym
PHSU02
Official Title
A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pergamum AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Adhesions
Keywords
Surgical Adhesions, Post-surgical adhesions, Flexor tendon

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
PXL01
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PXL01
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is a physiological sodium chloride solution, which is clear and colourless.
Primary Outcome Measure Information:
Title
TAM2
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Wiig, MD, PhD
Organizational Affiliation
Dept. of Hand Surgery Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Hand Surgery, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Dept. of Hand Surgery, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie
City
Duisburg
ZIP/Postal Code
47166
Country
Germany
Facility Name
St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie
City
Essen
ZIP/Postal Code
45257
Country
Germany
Facility Name
Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
Facility Name
Dept. of Hand Surgery Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Dept. of Hand Surgery Malmö University Hospital
City
Malmö
ZIP/Postal Code
SE-20502
Country
Sweden
Facility Name
Dept. of Hand Surgery, Stockholm South General Hospital
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Dept. of Hand Surgery Uppsala University Hospital, entrance 70
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25340801
Citation
Wiig ME, Dahlin LB, Friden J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014.
Results Reference
derived

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

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