The Effect of OASIS Ultra on Critical Sized Wound Healing

NCT01848821 | Completed Phase 1 Results DMC

• 1 other identifier: 2012-P-001903/1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Wound; Infective Wound; Iatrogenic Critical Sized Wound Defects; Wound Healing

Keywords

OASIS ultra; faster healing time; better healing quality; standard of care

Outcome Measures

Primary Outcomes (1)

• Change in Wound Size From Baseline to 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.

  Baseline, Final Wound Evaluation up to 60 Days Later

Secondary Outcomes (2)

• Change in Histological Acute Inflammation Score From Baseline to Skin Grafting Procedure

  Baseline, Final Skin Grafting Procedure

• Change in Histological Repair Score From Baseline to Skin Grafting Procedure

  Baseline, final Skin Grafting procedure

Study Arms (2)

OASIS half of wound

OTHER

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

Standard therapy half of wound

OTHER

Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application.

Device: Wound VAC Standard Therapy

Interventions

OASIS Ultra DEVICE

Porcine derived intestinal submucosa

OASIS half of wound

Wound VAC Standard Therapy DEVICE

Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound

Also known as: Negative Pressure Wound Device

Standard therapy half of wound

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Limitations and Caveats

This study is limited by its small sample size.

Results Point of Contact

• Title: Dr. Daniel Dante Yeh, Assistant Professor of Surgery
• Organization: Massachusetts General Hospital

dyeh2@partners.org

617-724-8604

Study Officials

• Daniel Dante Yeh, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma & Critical Care Surgeon

Model Details: OASIS

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Locations

US (1)