RecruitingNot Applicable

Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.

France300 participantsStarted 2025-12-11

Plain-language 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 management and prevention

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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, * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Major Depressive Episodes

Timeframe: Weeks 6, Month 3, Month 6 and Month 12

Trial details

NCT IDNCT07125196

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Benjamin BOUYER, PROF

+335 56 79 87 18 b.bouyer@chu-bordeaux.fr

View on ClinicalTrials.gov More Surgical Site Infections trials