Hand InfectionsHandInfNCT06630988
Diagnostic and Management of Hand Infection.
An observational study of Hand Infections and Including Whitlows, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Infections, Including Whitlows, Tendinous Infections
- What is being tested?
- Failure rates
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- osteomyelitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Failure rates
- Keywords
- Hand infection, Whitlows, Tendinous infections, Septic arthritis
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Failure ratesOther
Describe the management failure rate for hand infections, including panariasis, phlegmons and arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Hand infection | Description of whitlows, tendinous infections and septic arthritis diagnostic, management and outcome Descriptive study, no intervention Receives: Other: Failure rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment failure during the management of hand infections.
Treatment failure will be defined as infection persistence or relapse, need of unplanned surgery for septic reason or infection-related death.
Measured: between 01/01/2014 and 31/12/2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Valour Pr Florent Valour, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630988
- Sponsor's protocol ID
- 24-5342
- Acronym
- HandInf
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Management of Hand Infection: a Retrospective Cohort in a Tertiary Care Center.
- ClinicalTrials.gov ID
- NCT06630988
- Acronym / sponsor ID
- HandInf / 24-5342
- Keywords
- Hand infection, Whitlows, Tendinous infections, Septic arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand infection | – | Other: Failure ratesDescription of whitlows, tendinous infections and septic arthritis diagnostic, management and outcome Descriptive study, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- osteomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Failure ratesDescribe the management failure rate for hand infections, including panariasis, phlegmons and arthritis. | Other | Hand infection |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent Valour Pr Florent Valour, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Infections and Including Whitlows, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treatment failure during the management of hand infections. (time frame: between 01/01/2014 and 31/12/2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.