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临床试验/NCT01938066
NCT01938066已完成不适用

Clinical Outcomes for Patients With Acute Surgical Wounds Treated With Procellera and Negative Pressure Therapy Versus Standard of Care, Negative Pressure Therapy Only

Gayle Gordillo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Wound Infection

研究概览

简要总结

The purpose of this study is to determine if Procellera speeds wound healing. The study will examine colonization (bacterial growth), pain and pain medication and reduced cost of care by using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is placed in your wound to help heal the wound faster.

详细描述

The study will consent 30 patients undergoing surgery through the abdominal wall and the skin incision will intentionally be left open. Subjects will be randomized using a random number generator. Each number will be placed in an envelope numbered 1-30. Arm 1 will be even numbers and Arm 2 will be odd numbers. A researcher not affiliated with the study will generate the numbers and place them in the envelopes. Arm 1 will place fifteen subjects on Negative Pressure Therapy Only and Arm 2 will place fifteen subjects on Negative Pressure and Procellera. Arm 1 (Negative Pressure Only) will have their dressing changed 3 times per week which is the standard of care for Negative Pressure Therapy. Arm 2 (Negative Pressure Therapy and Procellera) will have their dressing changed every 5 days. Arm 1 and 2 will have a tissue specimen taken on the 5th day only. The tissue will be taken from debrided material and sent for culture. The Negative Pressure Therapy Sponge, which is discarded after each dressing change, will be collected, lavaged with saline and the cells will be examined for macrophage function and the wound fluid will be tested for inflammation response. Photographs, wound measurements, pain scale and pain medication will also be completed at each dressing change. We will check the progress of the wound along with your surgeon during the subject's 30 day surgical follow up in the surgeon's office. The wound will be measured (if not healed), photograph's taken and their pain level assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old that are undergoing abdominal wall surgery

排除标准

  • Below 18 years old and not having abdominal wall surgery

结局指标

主要结局

Wound Infection

时间窗: At the end of 5 days

At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound

次要结局

  • Amount of Pain Medication Used (Morphine)(5 days)

研究者

发起方
Gayle Gordillo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gayle Gordillo

Associate Professor

Ohio State University

研究点 (2)

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