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Completed

NCT Number: NCT03755349

Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

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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Key information

Who can participate

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:

  • 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

Treatment and study plan

Placement of burr-hole covers

Device

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

No placement of burr-hole covers

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. Skin depression

    Time frame: 90 days and 12 months postoperative

    Rate of skin depression, rated as yes vs. no

  4. 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

  5. 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))

  6. 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)

  7. Disability

    Time frame: 90 days postoperative

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

Other outcomes

  1. Home time

    Time frame: 90 days and 12 months postoperative

    Home time, as surrogate marker of disability

  2. Safety Outcome - intraoperative complication

    Time frame: Day of surgery

    Any complication occurring during the surgery

  3. 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.

  4. Safety Outcome - hematoma recurrence

    Time frame: 90 days and 12 months postoperative

    Hematoma recurrence per side requiring re-operation

  5. Safety Outcome - local wound infection

    Time frame: 90 days and 12 months postoperative

    Local wound infection requiring surgical revision per side

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 27, 2018
Registry last updated
Oct 3, 2022

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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