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Local Warming: Effects on Wound Infection and Healing

局部变暖：对伤口感染和愈合的影响

基本信息

批准号：
7257232
负责人：
JOANNE D WHITNEY
金额：
$ 46.1万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-09 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7257232
关键词：
Abdomen Accounting Antibiotic Therapy Antibiotics Asepsis B-Lymphocytes Bacteria Biological Assay Body Weight CD3 Antigens CD34 gene Caring Cell physiology Cells Centers for Disease Control and Prevention (U.S.)Classification Clinical Clinical Research Colectomy Collagen Colorectal Surgery Controlled Study Cutaneous Data Debridement Depth Dose Electrodes Endothelial Cells Enzymes Erythema Excision Exudate Flow Cytometry Gastric Bypass Gene Expression Goals Healed Heating Hospitalization Hour Hydrogen Peroxide Hydroxyproline Hypoxia Immune Immune response Immunohistochemistry Impaired wound healing Incidence Infection Laser-Doppler Flowmetry Length of Stay MS4A1 gene Manuals Measures Methods Morbidity - disease rate Nosocomial Infections Numbers Obesity Operative Surgical Procedures Outcome Oxidants Oxygen Oxygen measurement, partial pressure, arterial PECAM1 gene Patients Perfusion Perioperative Population Postoperative Period Process Production Randomized Randomized Clinical Trials Rate Repeat Surgery Reporting Research Research Personnel Resistance Resistance to infection Risk Sampling Score Serous Signal Transduction Site Standards of Weights and Measures Stem cells Stimulus Stomach Subcutaneous Tissue Surgical incisions Surgical wound System T-Lymphocyte Temperature Testing Tissues Vascular Endothelial Growth Factor Receptor-2 Vascular Endothelial Growth Factors Week Work Wound Healing Wound Infection angiogenesis bacterial resistance clinical efficacy cost day dosage experience healing improved injured macrophage natural hypothermia neutrophil pathogen programs repaired response subcutaneous vasoconstriction wound

项目摘要

Surgical site infections (SSI) account for 37% of US hospital infections and increase morbidity and cost. High rates (10-22%) of SSI are associated with colorectal surgery and obesity. Bacterial resistance requires oxygen, and higher tissue oxygen limits infection in general surgery patients. Control of core and local temperature may increase infection resistance by modulating perfusion, oxygenation, angiogenesis and immune cell responses. Perioperative hypothermia reduces tissue oxygen while normothermia lowers SSI rates. Warming injured tissues locally may offer additional benefit. Increased subcutaneous oxygen (PscO2) and fewer infections are reported in patients receiving pre-surgical local warming. Warming incisions immediately after surgery and intermittently for two days after gastric bypass or colectomy surgery reduced infection rates, but systematic study of clinical outcomes and potential mechanisms is lacking. Further study is needed to determine efficacy and dosage, and to investigate clinical and cellular outcomes. Aim 1: Conduct a large (n=180) randomized clinical trial to more definitively determine the clinical efficacy of local warming (for one hour mmediately post surgery, repeated every 8-10 hours for 5 more sessions) in reducing the incidence of SSI and wound complications. SSI and wound complications will be evaluated during hospitalization and for 6 weeks post-surgery by a) ASEPSIS Wound Scoring System; b) CDC Criteria for Classification of SSI. Aim 2: Compare patients randomized to local warming to those randomized to usual care on a variety of tissue and cellular variables, in order to understand the impact of warming on these variables. Variables to be measured include: 2.1 Wound tissue responses in test wound samples obtained on postoperative day 9, including: a) Indicators of Angiogenesis (determined by flow cytometry): 1. Percent of endothelial progenitor cells (EPC) CD133 positive, CD34 and VEGFR-2 co-expressing) 2. Percent of endothelial cells (CD31 positive) 3. Presence of endothelial cells (CD31 positive) and EPC (CD34 and VEGFR-2 co-expressing) confirmed by mmunohistochemistry. b) Indicators of Immune Response (determined by flow cytometry) 1. Percent of macrophages (CD68 positive), T cells (CDS positive), and B cells (CD20 positive) 2. Presence of macrophages (CD68 positive), T cells (CDS positive), and B cells (CD20 positive) confirmed by Immunohistochemistry c) Indicator of Collagen Synthesis (determined by manual colorimetric microtiter plate assay) 1. Hydroxyproline quantity. 2.2. PscO2 and temperature responses in test wound sites on postoperative days 0, 1 and 2 using a subcutaneous tonometer/micro-electrode and thermocouple system. 2.3. Perfusion (BF) in the surgical incision on postoperative days 3, 5 and 9 using Laser Doppler Flowmetry (LDF).

手术部位感染 (SSI) 占美国医院感染的 37%，并增加了发病率和费用。 SSI 的高发生率 (10-22%) 与结直肠手术和肥胖有关。细菌抵抗力需要氧气，较高的组织氧含量可以限制普通外科患者的感染。控制核心和局部温度可以通过调节灌注、氧合、血管生成和免疫细胞反应来提高感染抵抗力。围手术期低温会减少组织氧含量，而正常体温会降低 SSI 率。局部加热受伤的组织可能会带来额外的好处。据报道，接受术前局部加温的患者皮下氧气 (PscO2) 增加，感染减少。手术后立即加热切口以及胃绕道手术或结肠切除手术后间歇性加热切口两天可降低感染率，但缺乏对临床结果和潜在机制的系统研究。需要进一步研究来确定疗效和剂量，并调查临床和细胞结果。目标 1：进行一项大型 (n=180) 随机临床试验，以更明确地确定局部加温（手术后立即加温一小时，每 8-10 小时重复一次，再进行 5 次）在降低 SSI 和伤口并发症发生率方面的临床疗效。 SSI 和伤口并发症将在住院期间和术后 6 周内通过 a) ASEPSIS 伤口评分系统进行评估； b) CDC SSI 分类标准。目标 2：将随机接受局部变暖的患者与随机接受常规护理的患者的各种组织和细胞变量进行比较，以了解变暖对这些变量的影响。要测量的变量包括： 2.1 术后第 9 天获得的测试伤口样本中的伤口组织反应，包括： a) 血管生成指标（通过流式细胞术测定）： 1. 内皮祖细胞 (EPC) CD133 阳性、CD34 和 VEGFR-2 共表达）的百分比 2. 内皮细胞（CD31 阳性）的百分比 3. 内皮细胞（CD31）的存在积极）和免疫组织化学证实的 EPC（CD34 和 VEGFR-2 共表达）。 b) 免疫反应指标（通过流式细胞术测定） 1. 巨噬细胞（CD68 阳性）、T 细胞（CDS 阳性）和 B 细胞（CD20 阳性）的百分比 2. 通过免疫组织化学证实巨噬细胞（CD68 阳性）、T 细胞（CDS 阳性）和 B 细胞（CD20 阳性）的存在 c) 胶原合成指标（通过手动比色微量滴定板测定测定） 1. 羟脯氨酸的量。 2.2.使用皮下眼压计/微电极和热电偶系统在术后第 0、1 和 2 天测试伤口部位的 PscO2 和温度反应。 2.3.术后第 3、5 和 9 天使用激光多普勒血流计 (LDF) 对手术切口进行灌注 (BF)。