The Effect of OASIS Ultra on Critical Sized Wound Healing

Completed · Phase 1

Conditions studied: Traumatic Wound, Infective Wound, Iatrogenic Critical Sized Wound Defects, Wound Healing

In brief

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.

Key facts

Study ID

NCT01848821

Run by

Massachusetts General Hospital

People needed

7

Starts

2013-05-01

Expected to finish

2015-07-01

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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