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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
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
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 : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: OASIS
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

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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. Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later [ Time Frame: Baseline, Final Wound Evaluation up to 60 Days Later ]
    High-resolution digital photographs of the wound are taken (with a measurement scale included in the picture) at baseline and during serial wound evaluations in the operating room, at the bedside, and in the clinic. The picture is then uploaded into a wound tracing software program (Analyzing Digital images, www.umassk12.net/adki/) and wound area is calculated. Only the Baseline Measure and Final Wound Evaluation are used to calculate the Primary Outcome.


Secondary Outcome Measures :
  1. Change in Histological Acute Inflammation Score From Baseline to Skin Grafting Procedure [ Time Frame: Baseline, Final Skin Grafting Procedure ]

    At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated.

    Only biopsies from the Baseline and Final Skin Grafting Procedure are used to calculate this outcome measure.

    Parameters of acute inflammation (polymorphonuclear neutrophil infiltrate, edema, hemorrhage, and necrosis) were semiquantitatively assessed using a scoring system as follows: 0, non/minimal; 1, mild; 2, moderate, 3, marked. Each parameter was assigned a score, for a minimum and maximum total possible score of 0 and 12. A higher score represents a higher degree of acute inflammation.


  2. Change in Histological Repair Score From Baseline to Skin Grafting Procedure [ Time Frame: Baseline, final Skin Grafting procedure ]

    At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated.

    Parameters of tissue repair (fibroblast proliferation, collagen density, and neovascularization) were semiquantitatively assessed using a scoring system as follows: 0, none/minima; 1, mild; 2, moderate; 3, marked. Each parameter was assigned a score for a total minimum and maximum possible score of 0 and 9. A higher score represents more advanced wound healing.




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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    
Other Study ID Numbers: 2012-P-001903/1
First Posted: May 8, 2013    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
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