Pilot Study of the Effect of OASIS Ultra on Critical Sized Wound Healing
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later
研究概览
简要总结
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.
详细描述
The eligible participants for this study include all patients >18 years with traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater) with a quantitative wound culture < 105. Accrual of patients will take place at the Massachusetts General Hospital Churchill Surgical Service. All eligible patients will be identified by physician care givers on the Churchill service. Non-study affiliated physicians will then approach the patient and/or his or her healthcare proxy with a consent form and a direct description of the study. If the patient and/or his or her healthcare proxy agree to proceed with inclusion then the described protocol will be followed.
Patients with the following medical diagnoses will be excluded from the study:
- 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).
Subject Enrollment:
The study will take place between January 1, 2013 (or IRB approval date) and June 30, 2015. The eligible participants for this study include all patients >18 years with traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater) with a quantitative wound culture < 105. Accrual of patients will take place at the Massachusetts General Hospital Churchill Surgical Service. All eligible patients will be identified by physician care givers on the Churchill service. Non-study affiliated physicians will then approach the patient and/or his or her healthcare proxy with a descriptive consent form and a verbal explanation of the study. If the patient and/or his or her healthcare proxy agree to proceed with inclusion then the described protocol will be followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients >18 years
- •traumatic, infective or iatrogenic critical sized wound defects (50 sq cm or greater)
- •quantitative wound culture < 105.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: OASIS Ultra (Device)
Standard therapy half of wound
Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application.
干预措施: Wound VAC Standard Therapy (Device)
结局指标
主要结局
Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later
时间窗: 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.
次要结局
- 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)
研究者
Daniel Dante Yeh
Trauma & Critical Care Surgeon
Massachusetts General Hospital