<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755349</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2018-01180</org_study_id>
    <nct_id>NCT03755349</nct_id>
  </id_info>
  <brief_title>Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma</brief_title>
  <acronym>CORRECT-SCAR</acronym>
  <official_title>COveRs to impRove EsthetiC ouTcome After Surgery for Chronic Subdural hemAtoma by buRr Hole Trepanation (CORRECT-SCAR) - a Single-blinded, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker European Operations BV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical-functional result after frontal and parietal burr-hole trepanation for the&#xD;
      treatment of chronic subdural hematoma (cSDH) is effective with regards to control of the&#xD;
      hematoma and regression of symptoms (headache, decreased vigilance and neurological&#xD;
      deficits). However, in patients the treatment may leave visible depressions of the scalp,&#xD;
      just above the trepanation sites, that typically develop gradually after weeks - months after&#xD;
      the procedure. A considerable proportion of patients find this aesthetically, functionally&#xD;
      and psychologically disturbing; the skin depressions may even cause pain or interfere with&#xD;
      activities of daily living, such as combing, etc.&#xD;
&#xD;
      An effective method would exist to avoid this undesired treatment effect: Before the skin is&#xD;
      closed, a permeable titanium burr-hole plate could be attached above the trepanation site in&#xD;
      order to prevent the skin from sinking into the bony defect. However, this is rarely done&#xD;
      today, likely because there is no evidence that this treatment modification is effective and&#xD;
      safe. Moreover, as material is implanted, this causes additional costs.&#xD;
&#xD;
      The primary aim of this study is to evaluate whether the application of burr-hole plates on&#xD;
      both the frontal and parietal burr-hole in the context of burr-hole trepanation for the&#xD;
      treatment of cSDH can improve patient satisfaction with the aesthetic result of the surgery.&#xD;
&#xD;
      In addition, the study is intended to demonstrate that this additional measure will not&#xD;
      result in poorer hematoma control, poorer clinical/neurological outcomes, or additional&#xD;
      complications for the patient.&#xD;
&#xD;
      In a prospective, single-blind and controlled approach, we randomize 80 patients with uni- or&#xD;
      bilateral cSDH into an intervention group (with burr-hole plates) or into a control group&#xD;
      (without burr-hole plates).&#xD;
&#xD;
      The primary end result of the study is the patient's reported satisfaction with the aesthetic&#xD;
      outcome of the surgical scar. Secondary results are pain, functionality, neurological status,&#xD;
      health-related quality of life, residual hematoma volume, and complications (according to&#xD;
      Clavien-Dindo scale; especially re-operation rate for recurring cSDH and infections).&#xD;
&#xD;
      The study corresponds to a modern approach, since today's patients not only expect favorable&#xD;
      treatment results for their disease, but the therapy should also avoid permanent undesired&#xD;
      side-effects, if possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>As the evacuation of a cSDH encompasses trepanation of the skull with 2 burr-holes per side (each one in the frontal and parietal skull region), we will perform the study as follows:&#xD;
In patients with unilateral cSDH, we will cover either both (intervention group) or none of the burr holes with a burr hole cover (control group).&#xD;
In patients with bilateral cSDH, we will cover one side with burr hole covers (intervention side), while on the other side no burr hole covers are applied (control side).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will be blinded for allocation to the study group/side, but surgeons will not be. Patients will not be aware of the study group/side, since the operation takes place under general anesthesia. After surgery, it is not possible to see through the skin, whether or not a burr hole cover has been placed.&#xD;
The fact that patients are blinded for the study group allocation will be mentioned in the discharge letter (in order to inform the family physician), and the neurosurgical team of nurses and physicians will also be informed not to &quot;unblind&quot; the patient.&#xD;
Unblinding (and revealing a participant's allocated intervention) towards the patient is permissible only if the trial is suspended, prematurely terminated due to security concerns or completed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction with the aesthetic result of the scar</measure>
    <time_frame>90 days postoperative +/- 10 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with the aesthetic result of the scar</measure>
    <time_frame>12 months postoperative +/- 30 days</time_frame>
    <description>Patient satisfaction with the aesthetic results of the scars is determined using the ANA scale ranging from 0 (dissatisfied) - 10 (very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impairment in activities of daily living</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Impairment in activities of daily living (ADLs), rated as yes vs. no, with the following options: a) hairdressing, b) combing, c) washing, d) other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin depression</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Rate of skin depression, rated as yes vs. no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D Index</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D VAS</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>HrQoL - as PROM on the EQ-5D - allowing the calculation of the EQ-5D VAS (ranging from 0 (worst hrQoL) - 100 mm (best hrQoL))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological outcome</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Home time</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Home time, as surrogate marker of disability</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Outcome - intraoperative complication</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Any complication occurring during the surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Outcome - postoperative complication</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Any deviation from the regular postoperative course will be recorded on the Clavien-Dindo grading scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Outcome - hematoma recurrence</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Hematoma recurrence per side requiring re-operation</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety Outcome - local wound infection</measure>
    <time_frame>90 days and 12 months postoperative</time_frame>
    <description>Local wound infection requiring surgical revision per side</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiological Outcome - residual hematoma volume</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Residual hematoma volume in ccm3 will be measured per side on the CT scan routinely performed for clinical patient care</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiological Outcome - absolute hematoma clearance</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Absolute (in ccm3) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans</description>
  </other_outcome>
  <other_outcome>
    <measure>Radiological Outcome - relative hematoma clearance</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Relative (in %) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Hematoma, Subdural, Chronic</condition>
  <condition>Hematoma, Subdural, Intracranial</condition>
  <condition>Haematoma;Subdural;Traumatic</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both burr-holes are covered by burr-hole covers in patients with unilateral cSDH. In patients with bilateral cSDH, both burr-holes of the intervention side are covered by burr-hole covers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>None of the burr-holes are covered by burr-hole covers in patients with unilateral cSDH. In patients with bilateral cSDH, both burr-holes on the control side are left uncovered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of burr-hole covers</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Stryker® UN3 BURR HOLE COVER, 20mm, W/TAB, Item code 53-34520</other_name>
    <other_name>Stryker® UNIII AXS SCREWS, SELF-DRILLING, 1.5 x 4MM, Item code 56-15934</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No placement of burr-hole covers</intervention_name>
    <description>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.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants fulfilling all of the following inclusion criteria are eligible for the study:&#xD;
&#xD;
          -  Patients with first-time cSDH (hypodense, isodense, hyperdense or mixed-type in&#xD;
             CT-imaging), scheduled for uni- or bilateral double burr hole trepanation under&#xD;
             general anesthesia&#xD;
&#xD;
          -  Patient age ≥ 18 years&#xD;
&#xD;
          -  Patient non-comatose at time of inclusion (GCS &gt; 8 points)&#xD;
&#xD;
          -  Patient able to communicate (in terms of ability to hear, see, speak and understand)&#xD;
&#xD;
        The presence of any one of the following exclusion criteria will lead to exclusion of the&#xD;
        participant:&#xD;
&#xD;
          -  Patient with recurrent cSDH or previous surgery for cSDH&#xD;
&#xD;
          -  Patient with cSDH treated by craniotomy or by single burr hole trepanation&#xD;
&#xD;
          -  Patient with cSDH treated in local anesthesia&#xD;
&#xD;
          -  Patient unlikely to attend the follow-up (due to reasons of residency, dismal&#xD;
             prognosis, etc.)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known allergy against or incompatibility with Titanium&#xD;
&#xD;
          -  Known or suspected non-compliance&#xD;
&#xD;
          -  Inability to follow the study procedures, e.g. due to psychological disorders,&#xD;
             dementia, etc. of the participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin N Stienen, MD, FEBNS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich &amp; University Hospital Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luca Regli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Zurich &amp; University Hospital Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Menno R Germans, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsspital Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich &amp; University of Zurich</name>
      <address>
        <city>Zürich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Vasella F, Akeret K, Smoll NR, Germans MR, Jehli E, Bozinov O, Regli L, Stienen MN; CORRECT SCAR study group. Improving the aesthetic outcome with burr hole cover placement in chronic subdural hematoma evacuation-a retrospective pilot study. Acta Neurochir (Wien). 2018 Nov;160(11):2129-2135. doi: 10.1007/s00701-018-3659-9. Epub 2018 Aug 28.</citation>
    <PMID>30155645</PMID>
  </reference>
  <reference>
    <citation>Velz J, Vasella F, Akeret K, Dias SF, Jehli E, Bozinov O, Regli L, Germans MR, Stienen MN; CORRECT-SCAR study group. Patterns of care: burr-hole cover application for chronic subdural hematoma trepanation. Neurosurg Focus. 2019 Nov 1;47(5):E14. doi: 10.3171/2019.8.FOCUS19245.</citation>
    <PMID>31675709</PMID>
  </reference>
  <reference>
    <citation>Stienen MN, Akeret K, Vasella F, Velz J, Jehli E, Scheffler P, Voglis S, Bichsel O, Smoll NR, Bozinov O, Regli L, Germans MR; CORRECT-SCAR study group*. COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial. BMJ Open. 2019 Dec 6;9(12):e031375. doi: 10.1136/bmjopen-2019-031375.</citation>
    <PMID>31811007</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burr hole cover</keyword>
  <keyword>Chronic subdural hematoma</keyword>
  <keyword>Trepanation</keyword>
  <keyword>Aesthetic outcome</keyword>
  <keyword>Complications</keyword>
  <keyword>Patient satisfaction</keyword>
  <keyword>Burr hole plate</keyword>
  <keyword>Scar</keyword>
  <keyword>Skin depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hematoma, Subdural, Intracranial</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the results are published.</ipd_time_frame>
    <ipd_access_criteria>IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755349
org study id: BASEC 2018-01180
nct id: NCT03755349
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: As the evacuation of a cSDH encompasses trepanation of the skull with 2 burr-holes per side (each one in the frontal and parietal skull region), we will perform the study as follows:
In patients with unilateral cSDH, we will cover either both (intervention group) or none of the burr holes with a burr hole cover (control group).
In patients with bilateral cSDH, we will cover one side with burr hole covers (intervention side), while on the other side no burr hole covers are applied (control side).
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will be blinded for allocation to the study group/side, but surgeons will not be. Patients will not be aware of the study group/side, since the operation takes place under general anesthesia. After surgery, it is not possible to see through the skin, whether or not a burr hole cover has been placed.
The fact that patients are blinded for the study group allocation will be mentioned in the discharge letter (in order to inform the family physician), and the neurosurgical team of nurses and physicians will also be informed not to "unblind" the patient.
Unblinding (and revealing a participant's allocated intervention) towards the patient is permissible only if the trial is suspended, prematurely terminated due to security concerns or completed.
measure: Patient satisfaction with the aesthetic result of the scar
time frame: 90 days postoperative +/- 10 days
description: 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.
measure: Patient satisfaction with the aesthetic result of the scar
time frame: 12 months postoperative +/- 30 days
description: Patient satisfaction with the aesthetic results of the scars is determined using the ANA scale ranging from 0 (dissatisfied) - 10 (very satisfied)
measure: Impairment in activities of daily living
time frame: 90 days and 12 months postoperative
description: Impairment in activities of daily living (ADLs), rated as yes vs. no, with the following options: a) hairdressing, b) combing, c) washing, d) other
measure: Skin depression
time frame: 90 days and 12 months postoperative
description: Rate of skin depression, rated as yes vs. no
measure: EQ-5D Index
time frame: 90 days and 12 months postoperative
description: 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
measure: EQ-5D VAS
time frame: 90 days and 12 months postoperative
description: HrQoL - as PROM on the EQ-5D - allowing the calculation of the EQ-5D VAS (ranging from 0 (worst hrQoL) - 100 mm (best hrQoL))
measure: Neurological outcome
time frame: 90 days postoperative
description: 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)
measure: Disability
time frame: 90 days postoperative
description: Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)
measure: Home time
time frame: 90 days and 12 months postoperative
description: Home time, as surrogate marker of disability
measure: Safety Outcome - intraoperative complication
time frame: Day of surgery
description: Any complication occurring during the surgery
measure: Safety Outcome - postoperative complication
time frame: 90 days and 12 months postoperative
description: Any deviation from the regular postoperative course will be recorded on the Clavien-Dindo grading scale.
measure: Safety Outcome - hematoma recurrence
time frame: 90 days and 12 months postoperative
description: Hematoma recurrence per side requiring re-operation
measure: Safety Outcome - local wound infection
time frame: 90 days and 12 months postoperative
description: Local wound infection requiring surgical revision per side
measure: Radiological Outcome - residual hematoma volume
time frame: 90 days postoperative
description: Residual hematoma volume in ccm3 will be measured per side on the CT scan routinely performed for clinical patient care
measure: Radiological Outcome - absolute hematoma clearance
time frame: 90 days postoperative
description: Absolute (in ccm3) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
measure: Radiological Outcome - relative hematoma clearance
time frame: 90 days postoperative
description: Relative (in %) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
arm group label: Intervention group
arm group type: Experimental
description: Both burr-holes are covered by burr-hole covers in patients with unilateral cSDH. In patients with bilateral cSDH, both burr-holes of the intervention side are covered by burr-hole covers.
arm group label: Control group
arm group type: Active Comparator
description: None of the burr-holes are covered by burr-hole covers in patients with unilateral cSDH. In patients with bilateral cSDH, both burr-holes on the control side are left uncovered.
intervention type: Device
intervention name: Placement of burr-hole covers
description: 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
arm group label: Intervention group
other name: Stryker® UN3 BURR HOLE COVER, 20mm, W/TAB, Item code 53-34520
other name: Stryker® UNIII AXS SCREWS, SELF-DRILLING, 1.5 x 4MM, Item code 56-15934
intervention type: Other
intervention name: No placement of burr-hole covers
description: 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.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin N Stienen, MD, FEBNS
role: Principal Investigator
affiliation: University of Zurich & University Hospital Zurich
last name: Luca Regli, MD
role: Study Chair
affiliation: University of Zurich & University Hospital Zurich
last name: Menno R Germans, MD, PhD
role: Principal Investigator
affiliation: Universitätsspital Zürich
facility: 
country: Switzerland
citation: Vasella F, Akeret K, Smoll NR, Germans MR, Jehli E, Bozinov O, Regli L, Stienen MN; CORRECT SCAR study group. Improving the aesthetic outcome with burr hole cover placement in chronic subdural hematoma evacuation-a retrospective pilot study. Acta Neurochir (Wien). 2018 Nov;160(11):2129-2135. doi: 10.1007/s00701-018-3659-9. Epub 2018 Aug 28.
PMID: 30155645
citation: Velz J, Vasella F, Akeret K, Dias SF, Jehli E, Bozinov O, Regli L, Germans MR, Stienen MN; CORRECT-SCAR study group. Patterns of care: burr-hole cover application for chronic subdural hematoma trepanation. Neurosurg Focus. 2019 Nov 1;47(5):E14. doi: 10.3171/2019.8.FOCUS19245.
PMID: 31675709
citation: Stienen MN, Akeret K, Vasella F, Velz J, Jehli E, Scheffler P, Voglis S, Bichsel O, Smoll NR, Bozinov O, Regli L, Germans MR; CORRECT-SCAR study group*. COveRs to impRove AesthetiC ouTcome after Surgery for Chronic subdural haemAtoma by buRr hole trepanation (CORRECT-SCAR): protocol of a Swiss single-blinded, randomised controlled trial. BMJ Open. 2019 Dec 6;9(12):e031375. doi: 10.1136/bmjopen-2019-031375.
PMID: 31811007
responsible party type: Sponsor
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hematoma, Subdural, Intracranial
mesh term: Hematoma
sharing ipd: Yes
ipd description: IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: After the results are published.
ipd access criteria: IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).