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

NCT07325786 | Active Not Recruiting DMC

• 1 other identifier: ADU-PERKAB-WOUND
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Infection Bacterial; Identification

Keywords

Wound infection; Causative bacteria; Culture method

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

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.

Procedure: Tissue culture collection

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.

Procedure: Tissue culture collection

Interventions

Tissue culture collection PROCEDURE

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.

Percutaneous Wound Sampling with Analysis in Blood Culture (PERKA-B) Method; Standart Microbiological analyses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with infected wounds

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• Prof. Dr. Bülent M. Ertuğrul: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Department of Plastic, Reconstructive and Aesthetic Surgery

Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (9)

• Swanson T, Ousey K, Haesler E, Bjarnsholt T, Carville K, Idensohn P, Kalan L, Keast DH, Larsen D, Percival S, Schultz G, Sussman G, Waters N, Weir D. IWII Wound Infection in Clinical Practice consensus document: 2022 update. J Wound Care. 2022 Dec 1;31(Sup12):S10-S21. doi: 10.12968/jowc.2022.31.Sup12.S10.

  PMID: 36475844 BACKGROUND

• Senneville E, Albalawi Z, van Asten SA, Abbas ZG, Allison G, Aragon-Sanchez J, Embil JM, Lavery LA, Alhasan M, Oz O, Uckay I, Urbancic-Rovan V, Xu ZR, Peters EJG. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3687. doi: 10.1002/dmrr.3687. Epub 2023 Oct 1.

  PMID: 37779323 BACKGROUND

• Rondas AA, Halfens RJ, Schols JM, Thiesen KP, Trienekens TA, Stobberingh EE. Is a wound swab for microbiological analysis supportive in the clinical assessment of infection of a chronic wound? Future Microbiol. 2015;10(11):1815-24. doi: 10.2217/fmb.15.97.

  PMID: 26597427 BACKGROUND

• Krukerink M, Kievit J, Marang-van de Mheen PJ. Evaluation of routinely reported surgical site infections against microbiological culture results: a tool to identify patient groups where diagnosis and treatment may be improved. BMC Infect Dis. 2009 Nov 10;9:176. doi: 10.1186/1471-2334-9-176.

  PMID: 19900294 BACKGROUND

• Macdonald KE, Boeckh S, Stacey HJ, Jones JD. The microbiology of diabetic foot infections: a meta-analysis. BMC Infect Dis. 2021 Aug 9;21(1):770. doi: 10.1186/s12879-021-06516-7.

  PMID: 34372789 BACKGROUND

• Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444.

  PMID: 24973422 BACKGROUND

• Ertugrul B, Uckay I, Schoni M, Peter-Riesch B, Lipsky BA. Management of diabetic foot infections in the light of recent literature and new international guidelines. Expert Rev Anti Infect Ther. 2020 Apr;18(4):293-305. doi: 10.1080/14787210.2020.1730177. Epub 2020 Feb 19.

  PMID: 32052672 BACKGROUND

• Sen CK. Human Wound and Its Burden: Updated 2025 Compendium of Estimates. Adv Wound Care (New Rochelle). 2025 Sep;14(9):429-438. doi: 10.1177/21621918251359554. Epub 2025 Jul 14.

  PMID: 40660772 BACKGROUND

• Mengistu DA, Alemu A, Abdukadir AA, Mohammed Husen A, Ahmed F, Mohammed B, Musa I. Global Incidence of Surgical Site Infection Among Patients: Systematic Review and Meta-Analysis. Inquiry. 2023 Jan-Dec;60:469580231162549. doi: 10.1177/00469580231162549.

  PMID: 36964747 BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: December 5, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Start date: February 1, 2026 End date: April 1, 2026
• 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.

Locations

TU (1)