An interventional study of Tissue culture collection in Wound Infection Bacterial and Identification, sponsored by Prof. Dr. Bülent M. Ertuğrul. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Prof. Dr. Bülent M. Ertuğrul · Not applicable, Interventional, and Diagnostic
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.
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →This is the only study on the registry with Prof. Dr. Bülent M. Ertuğrul as lead sponsor.
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Exclusion Criteria:
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.
Procedure: Tissue culture collection
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.
Procedure: Tissue culture collection
After removal of necrotic tissue under sterile conditions, an adequate tissue specimen was obtained from the infected area using surgical techniques and placed into a sterile plain tube.
Conventional culture vs PERKA-B Method
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.
Time frame: 3 months
Plan to share: Yes — Microbiological data from tissue samples taken from infected wound of patients will be shared.
Supporting information: Csr
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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