Identifying adjustable risk factors for wound healing problems in patients who have had autologous cranioplasty (reimplantation of the removed section of their skull) following decompressive hemicraniectomy (removal of a piece of skull to relieve pressure on the brain)

Identifying adjustable risk factors for surgical site infection and aseptic bone resorption after autologous cranioplasty after decompressive hemicraniectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN46696883

Enrollment

200

Registered

2019-11-19

Start date

2010-01-01

Completion date

Unknown

Last updated

2021-01-25

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

Conditions

Decompressive hemicraniectomy for the following diagnoses: malignant middle cerebral artery infarction, severe traumatic brain injury, subarachnoid hemorrhage or intracerebral hemorrhage. Surgery

Interventions

The intervention has been performed as a clinical decision independent of this observational retrospective analysis. Patients do not need additional examinations or interventions as part of this trial

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 16-90 years at time of surgery 2. Treated using decompressive hemicraniectomy between 2010 and 2018 due to malignant stroke, traumatic brain injury, subarachnoid hemorrhage or intracerebral hemorrhage

Exclusion criteria

Exclusion criteria: 1. Decompressive hemicraniectomy for other diagnoses i.e. infection, post-tumor surgery etc 2. Children with a growing skull (aged <16 years) 3. Immunosuppressed patients (including iatrogenic)

Design outcomes

Primary

Measure	Time frame
Occurrence of surgical site infection, defined as a visible wound infection with or without dehiscence, or a positive spinal tap indication CSF infection requiring the removal of the implanted autologous bone flap. This was assessed by examining patients' medical records up to 8 years post-surgery. The minimal duration of follow-up for inclusion was 1 year.	—

Secondary

Measure	Time frame
Occurrence of aseptic bone resorption requiring the need for redo surgery and implantation of an allograft bone flap assessed by examining patients' medical records up to 8 years post-surgery. The minimal duration of follow-up for inclusion was 1 year.	—

Countries

Germany

Outcome results

None listed

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