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Studying the effect of subgaleal drainage in craniotomy

To investigate and compare the clinical outcomes of using and not using subgaleal drains in patients undergoing craniotomy surgery.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250107064301N1
Enrollment
46
Registered
2025-04-23
Start date
2022-06-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial space-occupying lesion. Intracranial space-occupying lesion found on diagnostic imaging of central nervous system

Interventions

Intervention 1: Intervention group: In the intervention group NDG, subgaleal hemovacuum drains were not inserted during craniotomy surgery for patients. All craniotomies were performed in the operatin

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients 15 to 65 years old Having a space-occupying brain lesion Has a medical indication for craniotomy surgery Having consent to enter the study Elective craniotomy surgery candidate

Exclusion criteria

Exclusion criteria: People who respond to non-surgical treatments (rest, medication, and physical therapy) Evidence of infection before surgery Patients undergoing reoperation Patients undergoing surgery on other organs at the same time Pregnant women People who have contraindications for MRI Individuals who are unwilling to participate in the study despite explaining the benefits of the plan and the study team's efforts to get them to participate People with mental disorders, mental retardation, and any psychiatric illness in the acute stage, such as psychosis, who are not receiving treatment and are unable to cooperate. Patients suspicious for immune disorders Diabetes and uncontrolled underlying kidney, liver, and heart disease Coagulation disorder People who are unable to communicate to respond, such as deaf, blind, and speech-impaired people

Design outcomes

Primary

MeasureTime frame
Hematoma at the surgical site. Timepoint: Twenty-four hours after surgery, 14 days after surgery, and 2 months after surgery. Method of measurement: CTscan.;Surgical site infection. Timepoint: Twenty-four hours after surgery, 14 days after surgery, and 2 months after surgery. Method of measurement: Blood cell count.;Length of hospital stay after surgery. Timepoint: The duration from the time of completion of surgery to the moment of patient discharge. Method of measurement: Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Peyravi dehsorkhi

Shahid Beheshti University of Medical Sciences

Peyravi.neurosurgeon@gmail.com+98 25 3882 6958

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026