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临床试验/NCT07325786
NCT07325786进行中(未招募)不适用

A Novel Method for the Examination of Infected Wound Specimens: Percutaneous Wound Sampling With Analysis in Blood Culture (PERKA-B) Method

Prof. Dr. Bülent M. Ertuğrul1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年12月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
Conventional culture vs PERKA-B Method

研究概览

简要总结

The aim of this study was to evaluate whether there is a difference in pathogen detection rates when tissue samples obtained from infected wound sites are processed using standard microbiological methods compared with inoculation into blood culture bottles using a predefined protocol.

详细描述

Wound infections represent a major global public health problem from clinical, epidemiological, and economic perspectives. Although the incidence of surgical site infections varies by region, the global rate is estimated to be approximately 2-3% . Chronic wounds, such as diabetic foot ulcers, venous ulcers, and pressure ulcers, constitute a similarly significant burden, with their prevalence increasing steadily worldwide. Recent estimates indicate that global expenditures related to wounds and wound infections have reached 148 billion US dollars. A substantial proportion of these costs is attributable to prolonged hospitalizations and antibiotic therapy.

Rational antibiotic use in wound infections relies primarily on the identification of the causative pathogen and determination of its antimicrobial susceptibility profile through microbiological examination of appropriate clinical specimens. Because superficially collected samples carry a high risk of contamination, deep tissue biopsy or aspirate specimens are generally considered more reliable than swab samples. In routine clinical microbiology practice, standard examination of wound specimens involves inoculation onto 5% sheep blood agar in combination with MacConkey or eosin methylene blue (EMB) agar. These media are incubated at 35°C for 24 hours and subsequently evaluated. If no growth is observed, incubation is extended for an additional 24 hours, and cultures without growth after 48 hours are reported as negative. When growth is detected, further identification of the isolates is performed.

Despite meticulous specimen collection, a substantial proportion of wound samples continue to yield negative culture results. Previous investigations have documented culture-negative rates of approximately 12% in diabetic foot infections, 19% in chronic wound infections, and 10-15% in surgical site infections. In such circumstances, clinicians are often obliged to initiate empirical antimicrobial therapy when microbiological analyses fail to identify a causative pathogen, despite strong clinical evidence of infection. This approach may lead to unwarranted antibiotic administration or reliance on broad-spectrum agents, thereby increasing the risk of adverse patient outcomes and contributing to elevated healthcare expenditures. Consequently, refinement of microbiological diagnostic techniques is imperative to ensure accurate pathogen identification and to facilitate the rational selection of antimicrobial therapy.

Media used in automated blood culture systems are enriched compared with conventional solid media, such as 5% sheep blood agar, MacConkey agar, and EMB agar, and are specifically designed to enhance microbial recovery. In addition, the longer incubation periods used in these systems may further improve pathogen detection. Although blood culture systems are routinely used to detect microorganisms in blood samples obtained from peripheral veins of patients with suspected bloodstream infections, there is currently no standardized protocol for the inoculation of non-blood clinical specimens into blood culture bottles.

研究设计

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

入排标准

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

入选标准

  • Patients with infected wounds

排除标准

  • Under 18 years of age

研究组 & 干预措施

Percutaneous Wound Sampling with Analysis in Blood Culture (PERKA-B) Method

Experimental

Percutaneous Wound Sampling with Analysis in Blood Culture (PERKA-B) Method:

Tissue samples were homogenized in 5 mL of sterile saline and vortexed at 2800-3000 rpm for 2 minutes. An aliquot was collected for standard culture, after which the remaining suspension was aseptically aspirated using a 5 mL sterile syringe and inoculated into a blood culture bottle. The inoculated bottles were incubated in an automated blood culture system, and growth signals were continuously monitored. The maximum incubation period was set at 5 days; samples with no growth signal at the end of this period were considered negative.

Upon detection of microbial growth, a sample from the blood culture bottle was subcultured onto 5% sheep blood agar and MacConkey agar plates and incubated aerobically at 35°C. Culture plates were examined for microbial growth at 24 hours. If no growth was observed, incubation was continued and plates were re-examined at 48 hours post-inoculation.

干预措施: Tissue culture collection (Procedure)

Standart Microbiological analyses

Experimental

Five milliliters (mL) of sterile saline were added to the sterile tube containing the tissue specimen. The tube was mixed for 2 minutes using a vortex mixer set at 2800-3000 revolutions per minute (rpm).

From the resulting fluid suspension, 0.05 mL was inoculated onto 5% sheep blood agar and MacConkey agar using a sterile loop under aseptic conditions. The inoculated 5% sheep blood agar and MacConkey agar plates were incubated at 35°C. 5% sheep blood agar and MacConkey agar'a inocule edilen Culture plates were examined for microbial growth at 24 hours. If no growth was observed, the plates were re-incubated and re-evaluated at 48 hours after inoculation.

干预措施: Tissue culture collection (Procedure)

结局指标

主要结局

Conventional culture vs PERKA-B Method

时间窗: 3 months

In this study, diagnostic performance measures will be calculated to evaluate the classification performance of blood culture relative to conventional culture in terms of positive and negative results.

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Bülent M. Ertuğrul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Bülent M. Ertuğrul

Prof. Dr.

Aydin Adnan Menderes University

研究点 (1)

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