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
  Purpose

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.


Condition Intervention
Surgical Wound Dehiscence
Device: PolyHeal 2
Device: Polyheal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by MediWound Ltd:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PolyHeal 2
Negatively charged 5-micron polystyrene microspheres in Water For Injection
Device: PolyHeal 2
PolyHeal is a sterile medical device
Other Names:
  • PolyHeal
  • PolyHeal is a sterile medical device
Active Comparator: PolyHeal
Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679678

Contacts
Contact: Dina Kofler dinak@mediwound.co.il
Contact: Alla Latovsky allal@mediwound.co,il, RN study coordinator

Locations
Israel
Soroka Medical Center Not yet recruiting
Beer Sheva, Israel
Principal Investigator: Alex Berezovsky, MD         
Western Galilee Hospital Not yet recruiting
Naharia, Israel
Principal Investigator: Eyal Gur, MD         
Souraski Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Eyal Gur, MD         
Principal Investigator: Eyal Gur, MD         
Sponsors and Collaborators
MediWound Ltd
Investigators
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
  More Information

No publications provided

Responsible Party: MediWound Ltd
ClinicalTrials.gov Identifier: NCT01679678     History of Changes
Other Study ID Numbers: MWPH-2012-08-01
Study First Received: August 20, 2012
Last Updated: September 1, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Surgical Wound Dehiscence
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014