UnIversity Medical Center Rostock
Rostock, 18057, Germany
Location status: Recruiting
Location contact
Daniel PD. Dr. med. habil. Dubinski, MD MSc
CONTACT
Sae-Yeon Won, MD
CONTACT
NCT Number: NCT07556991
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown.
The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Rostock, 18057, Germany
Location status: Recruiting
Daniel PD. Dr. med. habil. Dubinski, MD MSc
CONTACT
Sae-Yeon Won, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.
Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.
Time frame: 6 months
The primary objective is to determine if this postoperative antibiotic course reduces the rate of symptomatic cSDH recurrence requiring re-operation within six months. A pre-planned subgroup analysis will be conducted to compare outcomes specifically for patients with a positive microbiological culture versus those with a negative culture.
Time frame: 2weeks
Contact information is provided by the study sponsor or research team.
University of Rostock
Other
Acronym: iSDH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06163547
Brain Diseases, Cardiovascular Diseases
Geneva, Switzerland
View Trial DetailsNCT07421453
Brain Diseases, Cardiovascular Diseases
Leuven, Belgium
View Trial DetailsNCT04511572
Brain Diseases, Cardiovascular Diseases
Amsterdam, Netherlands
View Trial DetailsNCT07626671
Brain Diseases, Cardiovascular Diseases
View Trial Details