Treatment of Fracture Related Infection in Latin America.

NCT05467644 | Unknown

• 1 other identifier: FRI LATIN AMERICA - AOLAT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative bone infection is a severe complication in the treatment of fractures and is more frequent than in elective joint replacement surgeries. Surgical treatment is based on meticulous debridement of bone and soft tissue, dead space management, soft tissue reconstruction when necessary, and restoration of bony stability in the non-union fracture. In addition, local antibiotic therapy is recommended in certain circumstances. This study aims to evaluate the results of surgical treatment of fracture-related infection in Latin America.

Conditions

Fracture; Osteomyelitis; Soft Tissue Injuries; Bone Loss

Keywords

Fracture; Osteomyelitis; Soft Tissue Injuries; Bone Loss

Outcome Measures

Primary Outcomes (1)

• Usefulness of the FRI diagnosing criteria

  To analyze the usefulness of the criteria proposed by the expert consensus for diagnosing fractures-related infections.

  at least 6 months after infection treatment

Secondary Outcomes (5)

• Surgical treatment

  at least 12 months after infection treatment

• Microbiological profile

  just after infection treatment

• Variables associated with outcomes

  at least 12 months after infection treatment

• Strategies for the management of soft tissue defects

  at least 6 months after infection treatment

• Quality of life - EQ-5D-3L

  at least 12 months after infection treatment

Interventions

Treatment of Fracture Related Infection PROCEDURE

Observational Retrospective Study. Only one group. Patients diagnosed with fracture-related infection and submitted to surgical treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Fracture-related Infection

You may qualify if:

• Adult patients (18 years or older)
• Infection after surgical fracture treatment occurred 90 days after the initial surgery.
• Definitive treatment in one of the centers involved
• Hospital admission from January 1, 2018, to December 31, 2020
• Minimum outpatient follow-up period of one year after the main surgery to treat the infection, assess the quality of life, and control of the infection.

You may not qualify if:

• Incomplete medical records

Sponsors & Collaborators

• Manoel Victorino Hospital: lead
• AO Trauma Latin America: collaborator
• Centro Médico Nacional de Occidente IMSS: collaborator
• University of Campinas, Brazil: collaborator
• Hospital Municipal Miguel Couto: collaborator
• Hospital Italiano de Buenos Aires: collaborator
• Hospital Pablo Tobón Uribe: collaborator

Study Sites (1)

Manoel Victorino Hospital

Salvador, Estado de Bahia, 40301155, Brazil

RECRUITING

Related Publications (13)

• Walter G, Kemmerer M, Kappler C, Hoffmann R. Treatment algorithms for chronic osteomyelitis. Dtsch Arztebl Int. 2012 Apr;109(14):257-64. doi: 10.3238/arztebl.2012.0257. Epub 2012 Apr 6.

  PMID: 22536302 BACKGROUND

• Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury. 2006 May;37 Suppl 2:S59-66. doi: 10.1016/j.injury.2006.04.010.

  PMID: 16651073 BACKGROUND

• Steinmetz S, Wernly D, Moerenhout K, Trampuz A, Borens O. Infection after fracture fixation. EFORT Open Rev. 2019 Jul 15;4(7):468-475. doi: 10.1302/2058-5241.4.180093. eCollection 2019 Jul.

  PMID: 31423330 BACKGROUND

• Alcantara JE JUNIOR, Aguiar RA, Sampaio JGL NETO, Azi ML, Sadigursky D, Alencar DF. FACTORS ASSOCIATED WITH THE DEVELOPMENT OF EARLY INFECTION AFTER SURGICAL TREATMENT OF FRACTURES. Acta Ortop Bras. 2018 Jan-Feb;26(1):22-26. doi: 10.1590/1413-785220182601173883.

  PMID: 29977139 BACKGROUND

• Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24.

  PMID: 28867644 BACKGROUND

• Depypere M, Morgenstern M, Kuehl R, Senneville E, Moriarty TF, Obremskey WT, Zimmerli W, Trampuz A, Lagrou K, Metsemakers WJ. Pathogenesis and management of fracture-related infection. Clin Microbiol Infect. 2020 May;26(5):572-578. doi: 10.1016/j.cmi.2019.08.006. Epub 2019 Aug 22.

  PMID: 31446152 BACKGROUND

• Zimmerli W, Sendi P. Orthopaedic biofilm infections. APMIS. 2017 Apr;125(4):353-364. doi: 10.1111/apm.12687.

  PMID: 28407423 BACKGROUND

• Hotchen AJ, McNally MA, Sendi P. The Classification of Long Bone Osteomyelitis: A Systemic Review of the Literature. J Bone Jt Infect. 2017 Sep 12;2(4):167-174. doi: 10.7150/jbji.21050. eCollection 2017.

  PMID: 29119075 BACKGROUND

• Morgenstern M, Moriarty TF, Kuehl R, Richards RG, McNally MA, Verhofstad MHJ, Borens O, Zalavras C, Raschke M, Kates SL, Metsemakers WJ. International survey among orthopaedic trauma surgeons: Lack of a definition of fracture-related infection. Injury. 2018 Mar;49(3):491-496. doi: 10.1016/j.injury.2018.02.001. Epub 2018 Feb 6.

  PMID: 29433799 BACKGROUND

• Metsemakers WJ, Kuehl R, Moriarty TF, Richards RG, Verhofstad MHJ, Borens O, Kates S, Morgenstern M. Infection after fracture fixation: Current surgical and microbiological concepts. Injury. 2018 Mar;49(3):511-522. doi: 10.1016/j.injury.2016.09.019. Epub 2016 Sep 11.

  PMID: 27639601 BACKGROUND

• Bezstarosti H, Van Lieshout EMM, Voskamp LW, Kortram K, Obremskey W, McNally MA, Metsemakers WJ, Verhofstad MHJ. Insights into treatment and outcome of fracture-related infection: a systematic literature review. Arch Orthop Trauma Surg. 2019 Jan;139(1):61-72. doi: 10.1007/s00402-018-3048-0. Epub 2018 Oct 20.

  PMID: 30343322 BACKGROUND

• Govaert GAM, Kuehl R, Atkins BL, Trampuz A, Morgenstern M, Obremskey WT, Verhofstad MHJ, McNally MA, Metsemakers WJ; Fracture-Related Infection (FRI) Consensus Group. Diagnosing Fracture-Related Infection: Current Concepts and Recommendations. J Orthop Trauma. 2020 Jan;34(1):8-17. doi: 10.1097/BOT.0000000000001614.

  PMID: 31855973 BACKGROUND

• Metsemakers WJ, Fragomen AT, Moriarty TF, Morgenstern M, Egol KA, Zalavras C, Obremskey WT, Raschke M, McNally MA; Fracture-Related Infection (FRI) consensus group. Evidence-Based Recommendations for Local Antimicrobial Strategies and Dead Space Management in Fracture-Related Infection. J Orthop Trauma. 2020 Jan;34(1):18-29. doi: 10.1097/BOT.0000000000001615.

  PMID: 31464858 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Osteomyelitis; Soft Tissue Injuries; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matheus Azi, PhD

CONTACT

+557132541250; matheus.azi@saude.ba.gov.br

Nilma Caldas

CONTACT

+557132541250; residenciamedicahmv@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 20, 2022
• Study Start: January 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

BR (1)