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

January 7, 2026 updated by: Prof. Dr. Bülent M. Ertuğrul

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34480
        • Başakşehir Çam and Sakura City Hospital, Department of Plastic, Reconstructive and Aesthetic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with infected wounds

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous Wound Sampling with Analysis in Blood Culture (PERKA-B) Method

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
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.
Experimental: Standart Microbiological analyses

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conventional culture vs PERKA-B Method
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Bülent M. Ertuğrul

Collaborators

Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADU-PERKAB-WOUND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Microbiological data from tissue samples taken from infected wound of patients will be shared.

IPD Sharing Time Frame

Start date: February 1, 2026 End date: April 1, 2026

IPD Sharing Access Criteria

Personal data and supporting information will be shared via a website accessible to researchers involved in the study. Only microbiological results of tissue samples will be available there.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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