NCT06630988

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 26, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

Hand infectionWhitlowsTendinous infectionsSeptic arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    between 01/01/2014 and 31/12/2023.

Study Arms (1)

Hand infection

Description of whitlows, tendinous infections and septic arthritis diagnostic, management and outcome Descriptive study, no intervention

Other: Failure rates

Interventions

Describe the management failure rate for hand infections, including panariasis, phlegmons and arthritis.

Hand infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCL - Hôpital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Florent Valour Pr Florent Valour, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 8, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations