Surgihoney Reactive Oxygen对3级和4级腹疝复杂腹壁重建(AWR)后手术部位感染(SSI)的影响:一项单臂试验研究

Sam Parker, Tin Pavlovic, Reeya Patel, Peter Wilson, Jonathan McCullough, Alastair Windsor
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引用次数: 6

摘要

腹壁重建术(AWR)后伤口感染发生在超过三分之一的患者中,肠-皮瘘修复的发生率甚至更高。微生物学家设计了一种新型抗菌凝胶,称为外科蜂蜜活性氧(SHRO)。SHRO凝胶将应用于一组患者。我们的目标是进行一个试点案例系列,希望显示SHRO应用后局部伤口并发症的减少。方法和分析将对3级和4级(VHWG级)腹疝患者进行AWR患者单臂先导研究。根据CDC分级量表对患者术前伤口进行分级。术后根据Wilson手术部位感染分类对伤口进行分类。干预措施:SHRO将在腹筋膜闭合后和皮肤闭合前通过标准化方法应用。我们的系列结果将与我们的回顾性标准伤口护理结果进行比较。数据收集时间为2017年3月1日至2017年11月1日。主要结果:手术30天内手术部位感染,由临床医生在5、15和30天评估,并根据患者在此期间的自我报告进行评估。次要结局包括其他sso(血肿、血肿、伤口裂开、皮肤坏死)、住院时间、局部治疗的副作用和其他全身术后并发症。我们的目标是40名患者。结论本研究将提供招募和随访SHRO患者的方法和可行性评估。在这个试点试验的基础上,未来可能会提出一个完整的试验,这将为在AWR后伤口管理中使用SHRO的临床和成本效益提供额外的、有力的证据。这可能作为一个模型,伤口管理的复杂患者接受AWR。
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Impact of Surgihoney Reactive Oxygen on surgical site infection (SSI) after complex abdominal wall reconstruction (AWR) of grade 3 and 4 ventral Hernias: A single arm pilot study

Introduction

Following Abdominal Wall Reconstruction (AWR) wound infections occur in over one third of patients and rates can be even higher in entero-cutaneous fistula repair. A novel antimicrobial gel has been engineered by microbiologists called Surgihoney Reactive Oxygen (SHRO). SHRO gel will be applied to a group of patients. We aim to conduct a pilot case series with the hope to show a reduction in local wound complications after SHRO application.

Methods and analysis

A single arm pilot study of AWR patients will be carried out on patients with grade 3 and 4 (VHWG grade) ventral hernias. Patients’ pre-operative wounds will be graded according to the CDC classification scale. Post operatively the wounds will be classified according to the Wilson surgical site infection classification. Intervention: SHRO will be applied after abdominal fascial closure and before skin closure through a standardised method. Our results from the series will be compared to our retrospective standard wound care results. Data will be collected from 01.03.2017 to 01.11.2017. Primary outcome: Surgical site infection within 30 days of surgery, assessed by clinicians at 5, 15 and 30 days and by patient’s self-report for the intervening period. Secondary outcomes include other SSOs (haematoma, seroma, wound dehiscence, skin necrosis), duration of stay in hospital, reported side effects from local treatment and other systemic postoperative complications. We will aim for a cohort of 40 patients.

Conclusions

This study will provide an assessment of methods and feasibility of recruiting and following up patients who are treated with SHRO. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost effectiveness of SHRO in wound management following AWR. This may act as a model for the management of wounds in complex patients undergoing AWR.

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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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