Seeing if antibiotics given after surgery reduce recurrence of chronic subdural hematoma
Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
This trial will test whether a short course of amoxicillin‑clavulanate given after surgery can lower the chance of chronic subdural hematoma coming back in adults.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rostock Academic / other |
| Locations | 1 site (Rostock) |
| Trial ID | NCT07556991 on ClinicalTrials.gov |
What this trial studies
This is a randomized, interventional Phase 2/3 trial enrolling adults (>18) who undergo surgical treatment for chronic subdural hematoma. Participants are randomized to receive either amoxicillin‑clavulanic acid or placebo after surgery and are followed for hematoma recurrence and related clinical outcomes. Key exclusion criteria include current or recent antibiotic treatment, active infection, recurrent cSDH, and patients managed conservatively without surgery. The trial is conducted at the University Medical Center Rostock as a single‑center effort.
Who should consider this trial
Good fit: Adults over 18 undergoing surgical treatment for a first‑time chronic subdural hematoma who are not currently on antibiotics and have no active infection.
Not a fit: Patients with recurrent hematomas, those treated conservatively (non‑surgically), or those already receiving antibiotics or with active infections are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a short postoperative course of antibiotics could reduce recurrence and the need for repeat surgery in patients with chronic subdural hematoma.
How similar studies have performed: This is a relatively novel approach: retrospective reports suggest possible low‑grade infection in recurrent cases, but randomized controlled evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * surgical treatment of chronic subdural hematoma Exclusion Criteria: * prior or current antibiotic treatment * infection * recurrent chronic subdural hematoma * conservatively treated chronic subdural hematoma
Where this trial is running
Rostock
- UnIversity Medical Center Rostock — Rostock, Germany (Recruiting)
Study contacts
- Study coordinator: Daniel PD Dr.med.habil. Dubinski, MD MSc
- Email: daniel.dubinski@med.uni-rostock.de
- Phone: +49 381 494 6439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.