Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma (CORRECT-SCAR)

September 29, 2022 updated by: University of Zurich

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8091
        • University Hospital Zurich & University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Device: Placement of burr-hole covers
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
Active Comparator: Control group
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.
Other: No placement of burr-hole covers
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the aesthetic result of the scar
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.
90 days postoperative +/- 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with the aesthetic result of the scar
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)
12 months postoperative +/- 30 days
Impairment in activities of daily living
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
90 days and 12 months postoperative
Skin depression
Time Frame: 90 days and 12 months postoperative
Rate of skin depression, rated as yes vs. no
90 days and 12 months postoperative
EQ-5D Index
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
90 days and 12 months postoperative
EQ-5D VAS
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))
90 days and 12 months postoperative
Neurological outcome
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)
90 days postoperative
Disability
Time Frame: 90 days postoperative
Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)
90 days postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home time
Time Frame: 90 days and 12 months postoperative
Home time, as surrogate marker of disability
90 days and 12 months postoperative
Safety Outcome - intraoperative complication
Time Frame: Day of surgery
Any complication occurring during the surgery
Day of surgery
Safety Outcome - postoperative complication
Time Frame: 90 days and 12 months postoperative
Any deviation from the regular postoperative course will be recorded on the Clavien-Dindo grading scale.
90 days and 12 months postoperative
Safety Outcome - hematoma recurrence
Time Frame: 90 days and 12 months postoperative
Hematoma recurrence per side requiring re-operation
90 days and 12 months postoperative
Safety Outcome - local wound infection
Time Frame: 90 days and 12 months postoperative
Local wound infection requiring surgical revision per side
90 days and 12 months postoperative
Radiological Outcome - residual hematoma volume
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
90 days postoperative
Radiological Outcome - absolute hematoma clearance
Time Frame: 90 days postoperative
Absolute (in ccm3) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
90 days postoperative
Radiological Outcome - relative hematoma clearance
Time Frame: 90 days postoperative
Relative (in %) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans
90 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Stryker European Operations BV

Investigators

  • Principal Investigator: Martin N Stienen, MD, FEBNS, University of Zurich & University Hospital Zurich
  • Study Chair: Luca Regli, MD, University of Zurich & University Hospital Zurich
  • Principal Investigator: Menno R Germans, MD, PhD, Universitätsspital Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2019

Primary Completion (Actual)

September 19, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC 2018-01180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan 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 Sharing Time Frame

After the results are published.

IPD Sharing 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 Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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