Surgical Site InfectionsISODEPNCT07125196
Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
A study testing Data collection and self-administered questionnaire in people with Surgical Site Infections and Depression, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Surgical-site infection (SSI) in orthopedic surgery is a serious and frequent complication with many consequences on the patient's quality of life. This study aims to describe the incidence of depression and its complications like malnutrition in patients followed for surgical site infection to allow their best… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections, Depression, Malnutrition
- What is being tested?
- Data collection and self-administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient >18 years old
- Patient treated in infectiology for surgical site infection after orthopedic surgery of the limbs or spine:
- Prosthetic limb surgery
- Spinal surgery
- Traumatology: Osteosynthesis of peripheral limbs or spine
Who cannot join
- Patient under guardianship or curatorship,
- Pregnant, breastfeeding woman
- Person deprived of liberty by judicial or administrative decision,
- Person undergoing psychiatric treatment under duress requiring the consent of the legal representative.
- Person unable to express their consent,
- Person under legal protection,
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- Patient not affiliated to a social protection scheme.
- Patient with a history of diagnosed depression, hospitalization for depressive disorders or taking mood-regulating treatments.
- An initial BMI of less than < 18.5, the existence a cancerous pathology, an ongoing inflammatory disease, a pathology responsible for chronic undernutrition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romain HUGUET contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Benjamin BOUYER, PROF, b.bouyer@chu-bordeaux.fr
About this study
Surgical-site infection (SSI) in orthopedic surgery is a serious and frequent complication with many consequences on the patient's quality of life. This study aims to describe the incidence of depression and its complications like malnutrition in patients followed for surgical site infection to allow their best management and prevention
Read the detailed description
We will conduct a monocentric (department orthopedic surgery, University Hospital of Bordeaux, France) prospective observational study for 5 years, involving all patients treated for surgical site infection (prosthetic surgery and trauma surgery) The data collected will concern the general condition of the patients, demographic data, information about septic condition, psychiatric disorders, or nutritional conditions, as well as the care provided. A three-year follow-up will be planned
- Conditions
- Surgical Site Infections, Depression, Malnutrition
- Being tested
- Data collection and self-administered questionnaire
- Keywords
- surgical site infection, depression, malnutrition, orthopedic surgery, mood disorders, infection management, prospective study
- Medical subject headings
- Surgical Wound Infection, Depression, Malnutrition, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and self-administered questionnaireOther
Exhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), and self-administered questionnaire: a questionnaire concerning the psychological state of the patients (questionnaire according to DSM V) and a questionnaire on nutritional status.
| Study group | Role | What they receive |
|---|---|---|
| Surgical site infection | Other | Patients treated for surgical site infection (prosthetic surgery and trauma surgery) Receives: Other: Data collection and self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Depressive Episodes
Incidence of major depressive episodes as defined by the DSM V criteria, screened using the Major Depression Inventory (MDI) score. This will be assessed at baseline (M0) and at subsequent follow-up visits (Weeks 6, Month 3, Month 6 and Month 12).
Measured: Weeks 6, Month 3, Month 6 and Month 12
Secondary outcomes (8)
Socio-Demographic and Clinical Characteristics
Collection of socio-demographic data including age, sex, employment status, medical and surgical history, and smoking status at baseline and at the end of the study (M12).
Measured: Baseline (day 0) and 12 months (M12)
Incidence of Malnutrition and Its Risk Factors
- Malnutrition is defined by weight loss ≥ 5% in 1 month, ≥ 10% in 6 months, or ≥ 10% compared to usual weight before illness (HAS definition); BMI < 18.5 kg/m².
Measured: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
- Success of infection treatment defined by the cessation of ongoing antibiotic therapy.
Measured: Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12
Incidence of Malnutrition and Its Risk Factors
Monitoring current nutritional management (oral supplements, nutritional assessments conducted).
Measured: 12 months
Incidence of Malnutrition and Its Risk Factors
- Biological criteria for malnutrition: levels of albumin, pre-albumin, folate (B9), and vitamin B12.
Measured: 12 months
Incidence of Malnutrition and Its Risk Factors
- Assessment using the Mini Nutritional Assessment (MNA) questionnaire.
Measured: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
- Modifications in infection management due to malnutrition and depression events: treatment discontinuation, therapeutic changes.
Measured: Baseline ( Day 0), Week 6, Month 3, Month 6, and Month 12
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
- Quality of life scales: SF-36 (SF-36v2® Health Survey ©) and EQ-5D-5L (EuroQol Research Foundation©).
These parameters will be assessed at baseline (Day 0) and during follow-up visits (W6, M3, M6, and M12).
Measured: Baseline (Day0), Week 6, Month 3, Month 6, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start11 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin BOUYER, PROF, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125196
- Sponsor's protocol ID
- CHUBX 2024/09
- Acronym
- ISODEP
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2025
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
- ClinicalTrials.gov ID
- NCT07125196
- Acronym / sponsor ID
- ISODEP / CHUBX 2024/09
- Conditions
- Surgical Site Infections, Depression, Malnutrition
- Keywords
- surgical site infection, depression, malnutrition, orthopedic surgery, mood disorders, infection management, prospective study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 15 Aug 2025 (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.
Surgical-site infection (SSI) in orthopedic surgery is a serious and frequent complication with many consequences on the patient's quality of life. This study aims to describe the incidence of depression and its complications like malnutrition in patients followed for surgical site infection to allow their best management and prevention
Detailed description
We will conduct a monocentric (department orthopedic surgery, University Hospital of Bordeaux, France) prospective observational study for 5 years, involving all patients treated for surgical site infection (prosthetic surgery and trauma surgery) The data collected will concern the general condition of the patients, demographic data, information about septic condition, psychiatric disorders, or nutritional conditions, as well as the care provided. A three-year follow-up will be planned
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical site infection | Other | Other: Data collection and self-administered questionnairePatients treated for surgical site infection (prosthetic surgery and trauma surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient >18 years old
- Patient treated in infectiology for surgical site infection after orthopedic surgery of the limbs or spine:
Key exclusion criteria (9 listed)
- Patient under guardianship or curatorship,
- Pregnant, breastfeeding woman
- Person deprived of liberty by judicial or administrative decision,
- Person undergoing psychiatric treatment under duress requiring the consent of the legal representative.
- Person unable to express their consent,
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 |
|---|---|---|
| Data collection and self-administered questionnaireExhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), and self-administered questionnaire: a questionnaire concerning the psychological state of the patients (questionnaire according to DSM V) and a questionnaire on nutritional status. | Other | Surgical site infection |
Primary outcome
Incidence of Major Depressive Episodes
Time frame: Weeks 6, Month 3, Month 6 and Month 12
Incidence of major depressive episodes as defined by the DSM V criteria, screened using the Major Depression Inventory (MDI) score. This will be assessed at baseline (M0) and at subsequent follow-up visits (Weeks 6, Month 3, Month 6 and Month 12).
8 secondary outcomes
Socio-Demographic and Clinical Characteristics
Time frame: Baseline (day 0) and 12 months (M12)
Incidence of Malnutrition and Its Risk Factors
Time frame: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
Time frame: Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12
Incidence of Malnutrition and Its Risk Factors
Time frame: 12 months
Incidence of Malnutrition and Its Risk Factors
Time frame: 12 months
Incidence of Malnutrition and Its Risk Factors
Time frame: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
Time frame: Baseline ( Day 0), Week 6, Month 3, Month 6, and Month 12
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
Time frame: Baseline (Day0), Week 6, Month 3, Month 6, and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
Romain HUGUET contact
Benjamin BOUYER, PROF principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection and self-administered questionnaire in people with Surgical Site Infections and Depression, run by University Hospital, Bordeaux 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin BOUYER, PROF (+335 56 79 87 18, b.bouyer@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Depressive Episodes (time frame: Weeks 6, Month 3, Month 6 and Month 12). 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 9 Feb 2026.