A Study, Performed in Subjects With Post Traumatic-post Surgical Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen

This study is not yet open for participant recruitment.
Verified August 2012 by MediWound Ltd
Sponsor:
Information provided by (Responsible Party):
MediWound Ltd
ClinicalTrials.gov Identifier:
NCT01679678
First received: August 20, 2012
Last updated: September 1, 2012
Last verified: August 2012

August 20, 2012
September 1, 2012
November 2012
November 2013   (final data collection date for primary outcome measure)
Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01679678 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study, Performed in Subjects With Post Traumatic-post Surgical Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen
A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen

This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.

Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy confirmation subjects will be randomized into one of the two treatment groups and treated with study device once daily for 4 weeks.

Continuation of study device for additional period is based on wound healing progression and under investigator's discretion.

Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8 weeks untol week 12.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Surgical Wound Dehiscence
  • Device: PolyHeal 2
    PolyHeal is a sterile medical device
    Other Names:
    • PolyHeal
    • PolyHeal is a sterile medical device
  • Device: Polyheal
    PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
    Other Name: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM
  • Experimental: PolyHeal 2
    Negatively charged 5-micron polystyrene microspheres in Water For Injection
    Intervention: Device: PolyHeal 2
  • Active Comparator: PolyHeal
    Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
    Intervention: Device: Polyheal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hard to heal/chronic post traumatic post surgical wound refractory to healing at least 4 weeks prior to study treatment (one or more target wound/s will be eligible per each subject to be treated by the same agent)
  • Subjects who are able to read, understand, and sign the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.

Exclusion Criteria:

  • Presence of a systemic infection or significant local infection with copious purulent drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
  • Wounds with exposed bones, tendons or ligaments
  • Wounds with exposed orthopedic implants
  • Wounds with exposed breast prostheses
  • Uncontrolled diabetes with HbA1c >11%
  • Subjects with BMI greater than 35kg/m2
  • Woman who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
  • Participation in another clinical drug/device trial within 30 days prior to the Screening visit or during this study
Both
18 Years to 80 Years
No
Contact: Dina Kofler dinak@mediwound.co.il
Contact: Alla Latovsky allal@mediwound.co,il, RN study coordinator
Israel
 
NCT01679678
MWPH-2012-08-01
No
MediWound Ltd
MediWound Ltd
Not Provided
Principal Investigator: Alex Berezovsky, MD Head of Department of Plastic and reconstructive surgery
Principal Investigator: Eyal Gur, MD Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
Principal Investigator: Leonid Kogan, MD Head of Plastic Surgery Department Western Galilee Hospital
MediWound Ltd
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP