University Hospital Zurich & University of Zurich
Zurich, Canton of Zurich, 8091, Switzerland
NCT Number: NCT03755349
The clinical-functional result after frontal and parietal burr-hole trepanation for the treatment of chronic subdural hematoma (cSDH) is effective with regards to control of the hematoma and regression of symptoms (headache, decreased vigilance and neurological deficits). However, in patients the treatment may leave visible depressions of the scalp, just above the trepanation sites, that typically develop gradually after weeks - months after the procedure. A considerable proportion of patients find this aesthetically, functionally and psychologically disturbing; the skin depressions may even cause pain or interfere with activities of daily living, such as combing, etc.
An effective method would exist to avoid this undesired treatment effect: Before the skin is closed, a permeable titanium burr-hole plate could be attached above the trepanation site in order to prevent the skin from sinking into the bony defect. However, this is rarely done today, likely because there is no evidence that this treatment modification is effective and safe. Moreover, as material is implanted, this causes additional costs.
The primary aim of this study is to evaluate whether the application of burr-hole plates on both the frontal and parietal burr-hole in the context of burr-hole trepanation for the treatment of cSDH can improve patient satisfaction with the aesthetic result of the surgery.
In addition, the study is intended to demonstrate that this additional measure will not result in poorer hematoma control, poorer clinical/neurological outcomes, or additional complications for the patient.
In a prospective, single-blind and controlled approach, we randomize 80 patients with uni- or bilateral cSDH into an intervention group (with burr-hole plates) or into a control group (without burr-hole plates).
The primary end result of the study is the patient's reported satisfaction with the aesthetic outcome of the surgical scar. Secondary results are pain, functionality, neurological status, health-related quality of life, residual hematoma volume, and complications (according to Clavien-Dindo scale; especially re-operation rate for recurring cSDH and infections).
The study corresponds to a modern approach, since today's patients not only expect favorable treatment results for their disease, but the therapy should also avoid permanent undesired side-effects, if possible.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zurich, Canton of Zurich, 8091, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants fulfilling all of the following inclusion criteria are eligible for the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
Placement of a burr-hole cover (Stryker® UN3 BURR HOLE COVER, 20mm, W/TAB, Item code 53-34520) fixed with 2 screws (Stryker® UNIII AXS SCREWS, SELF-DRILLING, 1.5 x 4MM, Item code 56-15934) on each of two burr-holes
Other names: Stryker® UN3 BURR HOLE COVER, 20mm, W/TAB, Item code 53-34520, Stryker® UNIII AXS SCREWS, SELF-DRILLING, 1.5 x 4MM, Item code 56-15934
In the control group, none of the burr-holes is covered, representing our current standard of care. In patients with bilateral cSDH, none of the burr-holes on the control side are covered with burr-hole covers.
Time frame: 90 days postoperative +/- 10 days
For the primary outcome, patient satisfaction with the aesthetic results of the scars is determined using a patient-rated outcome measure (PROM), the Aesthetic Numeric Analogue (ANA) scale ranging from 0 (dissatisfied) - 10 (very satisfied). Here, on each side, the frontal and parietal scars are measured separately, and the mean scar satisfaction score per side is built by adding the two values and dividing the sum by two in each patient.
Time frame: 12 months postoperative +/- 30 days
Patient satisfaction with the aesthetic results of the scars is determined using the ANA scale ranging from 0 (dissatisfied) - 10 (very satisfied)
Time frame: 90 days and 12 months postoperative
Impairment in activities of daily living (ADLs), rated as yes vs. no, with the following options: a) hairdressing, b) combing, c) washing, d) other
Time frame: 90 days and 12 months postoperative
Rate of skin depression, rated as yes vs. no
Time frame: 90 days and 12 months postoperative
Health-related Quality of Life (HrQoL) - as PROM on the EQ-5D - allowing the calculation of the EQ-5D index that ranges from -0.074 (worst hrQoL) - 1.00 (best hrQoL) using European norms
Time frame: 90 days and 12 months postoperative
HrQoL - as PROM on the EQ-5D - allowing the calculation of the EQ-5D VAS (ranging from 0 (worst hrQoL) - 100 mm (best hrQoL))
Time frame: 90 days postoperative
Neurological outcome - as physician-rated outcome measure by the NIHSS (ranging from 0 (no neurological deficit) - 42 (severe neurological deficits)), performed by a physician who was trained in the use of the scale (certified)
Time frame: 90 days postoperative
Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)
Time frame: 90 days and 12 months postoperative
Home time, as surrogate marker of disability
Time frame: Day of surgery
Any complication occurring during the surgery
Time frame: 90 days and 12 months postoperative
Any deviation from the regular postoperative course will be recorded on the Clavien-Dindo grading scale.
Time frame: 90 days and 12 months postoperative
Hematoma recurrence per side requiring re-operation
Time frame: 90 days and 12 months postoperative
Local wound infection requiring surgical revision per side
Time frame: 90 days postoperative
Residual hematoma volume in ccm3 will be measured per side on the CT scan routinely performed for clinical patient care
Time frame: 90 days postoperative
Absolute (in ccm3) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
Time frame: 90 days postoperative
Relative (in %) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
University of Zurich
Other
COveRs to impRove EsthetiC ouTcome After Surgery for Chronic Subdural hemAtoma by buRr Hole Trepanation (CORRECT-SCAR) - a Single-blinded, Randomized Controlled Trial
Acronym: CORRECT-SCAR
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.
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