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The Effect of OASIS Ultra on Critical Sized Wound Healing

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ClinicalTrials.gov Identifier: NCT01848821
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Daniel Dante Yeh, Massachusetts General Hospital

Brief Summary:
The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovascularization present compared with control wounds. The investigators hypothesize that OASIS® Ultra will provide a faster healing time as well as the re-establishment of a dermis for further skin graft application. The investigators anticipate that our study will define parameters for the application of OASIS® Ultra as well as potentially demonstrating the advantages in healing time, healed wound quality and hospital stay.

Condition or disease Intervention/treatment Phase
Traumatic Wound Infective Wound Iatrogenic Critical Sized Wound Defects Wound Healing Device: OASIS Ultra Device: Wound VAC Standard Therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of OASIS Ultra on Critical Sized Wound Healing
Study Start Date : May 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
OASIS half of wound
OASIS will be applied to one half of the wound and standard of care consisting of wound vac only will be applied to the other half.
Device: OASIS Ultra
Porcine derived intestinal submucosa

Standard therapy half of wound
Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application.
Device: Wound VAC Standard Therapy
Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound
Other Name: Negative Pressure Wound Device




Primary Outcome Measures :
  1. Wound size [ Time Frame: 60 days ]
    Wound size will be assessed by serial photography and surface area measurement.


Secondary Outcome Measures :
  1. Wound healing quality [ Time Frame: 60 days ]
    serial wound edge biopsies will be obtained to assess vascularity, collagen deposition and cellularity of the wound edge in each arm.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients >18 years
  • traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater)
  • quantitative wound culture < 105.

Exclusion Criteria:

  • Wounds that cannot have a negative pressure wound device applied due to anatomical difficulty (i.e. proximity to perineum/anus) or exposed arteries/veins.
  • Patients who are DNR/DNI
  • Patients who are hemodynamically unstable or requiring pressors
  • Patients that are immunodeficient or immunocompromised (ie HIV)
  • Patients that have any allergy to porcine products
  • Patients that have a religious or ethical necessity to avoid porcine products
  • Patients whose wounds are derived from extension of mitotic lesions (ie ulcerative squamous cell carcinoma)
  • Patients whose wounds are expected to heal in less than seven days or be ready for skin grafting in less than seven days with standard therapy
  • Patients with full thickness burns
  • Patients with wound surface area of <50 sq cm
  • Pregnant patients (as confirmed by serum or urinary beta-Human Chorionic Gonadotrophin sampling or by History).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848821


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Daniel Dante Yeh, MD Massachusetts General Hospital

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Responsible Party: Daniel Dante Yeh, Trauma & Critical Care Surgeon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01848821     History of Changes
Other Study ID Numbers: 2012-P-001903/1
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by Daniel Dante Yeh, Massachusetts General Hospital:
OASIS ultra
faster healing time
better healing quality
standard of care

Additional relevant MeSH terms:
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Wounds and Injuries