Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Hematoma, Subdural, Chronic Hematoma, Subdural, Intracranial Haematoma;Subdural;Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Placement of burr-hole covers

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

No placement of burr-hole covers

Intervention Type 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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No