Sonication of Syndesmotic Screws

NCT03308617 | Unknown

• 1 other identifier: JenaUC
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implant infections are severe complications after internal fracture fixation surgery. Detection of causative agents of orthopedic implant-associated infections (OIAI) is demanding. Several authors reported increased identification rates of bacterial prevalence using different sonication procedures compared to standard tissue cultures samples, especially for low grade infections. On the author hand, contamination of implants without clinical signs of infection is reported in up to 30% during implant removals after uneventful fracture healing. The raised general questions are: 1.) Is a positive microbiological finding the result of contamination during the index surgery or during implant removal? 2.) Does contaminated implants without clinical or serological signs of infection have a pathological value?

Conditions

Periimplant Infection

Keywords

sonication

Outcome Measures

Primary Outcomes (1)

• Detection rate of syndesmotic screw contamination using a sonication procedure compared to standard wound swabs

  six weeks

Secondary Outcomes (1)

• Clinical manifestation of infections by contaminated fracture fixation implants

  six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with operatively treated ankle fractures.

You may qualify if:

• Patients with syndesmotic screw removal after open reduction and internal fixation with plates and additional syndesmotic screw of ankle fractures (Weber B or C) in our department.

You may not qualify if:

• Patients with immunosuppressive diseases or therapies,
• Pregnant women
• Patients with pre-operations on the same ankle-joint
• Patients with initial surgery for fracture fixation in other hospitals.

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Department of Trauma-, Hand- and Reconstructive Surgery

Jena, Thuringia, 07740, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin and wound swabs

Study Officials

• Florian Gras, PD Dr. med.

  Department of Trauma-, Hand- and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Kribus, Dr. med.

CONTACT

0049-3641-9322801; monique.kribus@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: April 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: October 12, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)