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Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions

2017年3月21日 更新者:Daniel Dante Yeh、Massachusetts General Hospital

A Prospective Observational Study of the Use of Negative Pressure Wound in High Risk Surgical Closed Incisions.

The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).

Hypothesis:

Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.

研究概览

详细说明

Wound infections continue to be a common and costly problem after surgery. Surgical site infections (SSIs) are the second most common type of health care - associated infections (HAI), occurring in 2% to 5% of patients undergoing surgery in the United States. This percentage corresponds to approximately 300,000 to 500,000 surgical site infections (SSIs) estimated to occur each year.

Most SSIs that do not involve implants are diagnosed within 3 weeks post--operatively . SSIs lead to increased hospital stay, cost, and risk of death. The cost attributable to SSI range from $3,000 to $29,000 per SSI per patient depending on the type of operation; thus, the total annual cost approximately reaches the $10 billions. On other analyses documented nearly 1 million additional inpatient-days and $1.6 billion in excess costs , as well as up to twice the costs of a patient without SSI. Moreover, SSIs increase mortality risk by 2 to 11 fold 11, while the 77% of deaths in patients with SSI are attributed directly to the SSIs. Several organizations have put forth guidelines for definition and recommendations to decrease their incidence. Attempts have been made to stratify patients into various categories on the basis of the type of surgical procedure and risk factors the patients have, including diabetes, malnutrition, and hypoxemia. These systems have been used to develop criteria for the prevention of wound infection.

Appropriate timing and dosing of antibiotics, type of skin preparation, temperature of the patient in the operating room, blood oxygen level of the patient during surgery, and management of blood glucose levels all have been standardized in an attempt to decrease wound infection rates . In addition, debridement of all tissue that may contribute to wound infection, particularly ischemic skin and subcutaneous tissue, is standard surgical procedure. Standardization has led to a small decrease in incidence but has not led to a significant reduction in the overall rate. One reason for this is the multifactorial nature of SSI development. Factors regarding patients and pre-operative status, operative procedures and intra-operative events, as well as postoperative course, all need to be addressed, and there is not a complete understanding of their range and impact. What is known is that at the time of wound closure, one needs a minimal number of bacteria in the wound, and the wound itself must be reasonably well perfused and oxygenated. After surgery, wound perfusion and oxygenation are evaluated by clinical appearance. If the wound does not appear ischemic, it is assumed that perfusion and oxygenation are adequate. Unfortunately, this has never been quantified. Negative-pressure wound therapy (NPWT) has been used to speed the healing of open wounds.

How this occurs is not completely understood, but increased generation of granulation tissue at the margins of the open wound implies increased generation of blood vessels and substances needed to promote wound healing.

The theory of negative pressure is the stimulation of wound healing on the basis of improved perfusion to the wound. This has been seen in open wounds and has recently been applied to closed surgical wounds thought to be at high risk for infection. Negative-pressure wound therapy was also applied to closed wounds in an attempt to improve wound perfusion and oxygenation, which in theory would eliminate these two variables from the wound infection equation.

Techniques - Procedures Complete closure of the abdominal wall and skin follows the completion of the index surgical procedure. Closed suction drains may be used at the time of skin closure in any patient who requires skin flap elevation to attain skin closure. Skin closure will be accomplished with dermal sutures and / or staples. Wound coverage will be done with the NPWT Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX). The application of the NPWT will be done as per manufacturer's instructions of use. The application of continuous negative pressure will be applied at 125 mm Hg.Antibiotics will be given to all patients. The post-operative use of antibiotics in the clear contaminated and contaminated cases will be 24-hour of prophylactic administration. The post-operative use of antibiotics for the dirty (infected) cases will be of therapeutic administration, as clinically indicated. In infected patients, cultures will be taken at the time of the index procedure, and the antibiotic treatment will be targeted to the culture results. Wounds will be assessed every 48 hours by dressing changes, and also at the time of final dressing removal and at 2 and 4 weeks after surgery. The dressing removal will take place at discharge OR at 5 - 7 post-operative days OR if clinically indicated, whichever comes first. Post-discharge follow-up The patients will be followed-up per routine at the surgical clinic. At 2 and 4 weeks after the date of the operation a formal evaluation will take place. Both evaluations must be in person at the surgical clinic.

研究类型

介入性

注册 (实际的)

10

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 95年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All five of the following criteria must be present for enrollment into the study:

    1. Signed written informed consent must be provided by the patient or by patient's legally acceptable representative, if patient unable to consent.
    2. Age > 18 years
    3. Abdominal operation entering the peritoneal cavity under general anesthesia for colostomy or ileostomy reversal or enterocutaneous fistula excision
    4. Clean - contaminated OR contaminated OR dirty wound (as defined by Wound Infection Surveillance) OR use of skin flaps for skin closure.
    5. Complete closure of the surgical wound including the skin.

Exclusion Criteria:

  • 1) Known allergic reaction at the wound dressing parts of the Prevena ™ Incision Management System.

(Included but not limited to: sensitivity to silver, allergic or hypersensitivity reaction to acrylic adhesives).

2) Inability to close the abdominal wall at the index procedure. 3) Inability to close the skin at the index procedure. 4) Patients under 18 years old. 5) Pregnant women test

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Negative Pressure Wound Therapy

After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.

For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation
大体时间:30 days
Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network
30 days

次要结果测量

结果测量
措施说明
大体时间
Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System.
大体时间:4 weeks

Secondary (composite) outcomes:

  1. other non infectious abdominal wound complications,
  2. damage to the skin caused by the dressing
  3. need to end the treatment prior the discharge OR prior to 5 -7 post- operative days.
  4. need for re-application of the system for any reason
4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2014年5月8日

首先提交符合 QC 标准的

2014年5月10日

首次发布 (估计)

2014年5月13日

研究记录更新

最后更新发布 (实际的)

2017年4月18日

上次提交的符合 QC 标准的更新

2017年3月21日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2013P002484

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Negative Pressure treatment的临床试验

3
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