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Hematoma, Subdural, ChronicCORRECT-SCARNCT03755349

Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

A study testing Placement of burr-hole covers and No placement of burr-hole covers in people with Hematoma, Subdural, Chronic and Hematoma, Subdural, Intracranial, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Placement of burr-hole covers and No placement of burr-hole covers
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteSwitzerland
Study dates
29 Jan 2019to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Participants fulfilling all of the following inclusion criteria are eligible for the study:

  • Patients with first-time cSDH (hypodense, isodense, hyperdense or mixed-type in CT-imaging), scheduled for uni- or bilateral double burr hole trepanation under general anesthesia
  • Patient age ≥ 18 years
  • Patient non-comatose at time of inclusion (GCS > 8 points)
  • Patient able to communicate (in terms of ability to hear, see, speak and understand)

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

  • Patient with recurrent cSDH or previous surgery for cSDH
  • Patient with cSDH treated by craniotomy or by single burr hole trepanation
  • Patient with cSDH treated in local anesthesia
  • Patient unlikely to attend the follow-up (due to reasons of residency, dismal prognosis, etc.)
  • Pregnancy
  • Known allergy against or incompatibility with Titanium
  • Known or suspected non-compliance
  • Inability to follow the study procedures, e.g. due to psychological disorders, dementia, etc. of the participant

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich & University of Zurich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read more

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.

Being tested
Placement of burr-hole covers, No placement of burr-hole covers
Keywords
Burr hole cover, Chronic subdural hematoma, Trepanation, Aesthetic outcome, Complications, Patient satisfaction, Burr hole plate, Scar, Skin depression
Medical subject headings
Hematoma, Subdural, Chronic, Hematoma, Subdural, Intracranial, Patient Satisfaction, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placement of burr-hole coversDevice

    Also called 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

    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

  • No placement of burr-hole coversOther

    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.

Study groups in NCT03755349
Study groupRoleWhat they receive
Intervention groupExperimentalBoth 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.
Receives: Device: Placement of burr-hole covers
Control groupActive comparatorNone 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.
Receives: Other: No placement of burr-hole covers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient satisfaction with the aesthetic result of the scar

    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.

    Measured: 90 days postoperative +/- 10 days

Secondary outcomes (7)

  1. Patient satisfaction with the aesthetic result of the scar

    Patient satisfaction with the aesthetic results of the scars is determined using the ANA scale ranging from 0 (dissatisfied) - 10 (very satisfied)

    Measured: 12 months postoperative +/- 30 days

  2. Impairment in activities of daily living

    Impairment in activities of daily living (ADLs), rated as yes vs. no, with the following options: a) hairdressing, b) combing, c) washing, d) other

    Measured: 90 days and 12 months postoperative

  3. Skin depression

    Rate of skin depression, rated as yes vs. no

    Measured: 90 days and 12 months postoperative

  4. EQ-5D Index

    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

    Measured: 90 days and 12 months postoperative

  5. EQ-5D VAS

    HrQoL - as PROM on the EQ-5D - allowing the calculation of the EQ-5D VAS (ranging from 0 (worst hrQoL) - 100 mm (best hrQoL))

    Measured: 90 days and 12 months postoperative

  6. Neurological outcome

    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)

    Measured: 90 days postoperative

  7. Disability

    Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)

    Measured: 90 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start29 Jan 2019
  3. Primary completion19 Sep 2021
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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: 1. 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). 2. 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).
Masking
Single blind
Who is masked
Participant
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03755349
Sponsor's protocol ID
BASEC 2018-01180
Acronym
CORRECT-SCAR
Status last verified
Sep 2022
First submitted
21 Nov 2018
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).

Publications

  • 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.

    PubMed 30155645

  • 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.

    PubMed 31675709

  • 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.

    PubMed 31811007

  • Stienen MN, Akeret K, Vasella F, Velz J, Jehli E, Voglis S, Bichsel O, Smoll NR, Bozinov O, Regli L, Germans MR; CORRECT-SCAR Study Group. COveRs to impRove EsthetiC ouTcome after Surgery for Chronic subdural hemAtoma by buRr hole trepanation-Results of a Swiss Single-Blinded, Randomized Controlled Trial. Neurosurgery. 2024 May 1;94(5):955-965. doi: 10.1227/neu.0000000000002778. Epub 2023 Dec 7.

    PubMed 38059611

Questions about this trial

What is this clinical trial studying?

A study testing Placement of burr-hole covers and No placement of burr-hole covers in people with Hematoma, Subdural, Chronic and Hematoma, Subdural, Intracranial, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction with the aesthetic result of the scar (time frame: 90 days postoperative +/- 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03755349, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

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