- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630988
Diagnostic and Management of Hand Infection. (HandInf)
October 4, 2024 updated by: Hospices Civils de Lyon
Diagnostic and Management of Hand Infection: a Retrospective Cohort in a Tertiary Care Center.
Primary or secondary (post-traumatic infections, notably related to bites, wounds, etc.) infections of the hand are very common situations, even if the epidemiology is poorly understood.
For example, hand bite injuries represent 1.2 million referrals to the healthcare system per year in the United States.
Their nosological framework extends from simple infections of the skin and soft tissues such as whitlows, to potentially severe deep damage such as arthritis and osteitis, or phlegmons of the tendon sheaths.
The diagnostic approach is not consensual, and the contribution of additional biological parameters (inflammatory syndrome) and morphological investigations (x-rays, ultrasound, CT-scan or MRI) is not codified.
Microbiology seems dominated by Staphylococcus aureus, but few studies have precisely described the microbial etiology.
Consequently, probabilistic antibiotic therapy and the need to take bacteriological samples for secondary adaptation are not standardized.
Likewise, surgical strategies (abstention, systematic washing or depending on evolution) remain operator dependent.
We consequently aim to described diagnostic, management and related outcomes or hand infections in a specialized tertiary care center.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1400
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
-
-
-
Lyon, France, 69003
- Hcl - Hopital Edouard Herriot
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Patients will be selected from the data base of the hand emergency surgery department of our tertiary care center, based on a principal or secondary diagnosis of BJI appearing alone or in combination with either sepsis or a specific surgical procedure - 1400 potential patients.
Description
Inclusion Criteria:
- all patient ≥ 18
- yo followed-up for a hand infection in our tertiary care center
- from 01/01/2014 to 31/12/2023, including
- whitlows
- tendinous infections
- septic arthritis
Exclusion Criteria:
- osteomyelitis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hand infection
Description of whitlows, tendinous infections and septic arthritis diagnostic, management and outcome Descriptive study, no intervention
|
Describe the management failure rate for hand infections, including panariasis, phlegmons and arthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of treatment failure during the management of hand infections.
Time Frame: between 01/01/2014 and 31/12/2023.
|
Treatment failure will be defined as infection persistence or relapse, need of unplanned surgery for septic reason or infection-related death.
|
between 01/01/2014 and 31/12/2023.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Florent Valour Pr Florent Valour, Pr, Hospices Civils de Lyon
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)
September 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
September 26, 2024
First Submitted That Met QC Criteria
October 4, 2024
First Posted (Actual)
October 8, 2024
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 4, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-5342
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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