Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

Not Applicable

Completed

• Conditions: Hematoma, Subdural, Chronic; Hematoma, Subdural, Intracranial; Haematoma;Subdural;Traumatic
• Interventions: Device: Placement of burr-hole covers; Other: No placement of burr-hole covers

• Registration Number: NCT03755349
• Lead Sponsor: University of Zurich

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-01-29
• Primary Completion: 2021-09-19
• Study Completion: 2022-01-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Placement of burr-hole covers	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.
Control group	No placement of burr-hole covers	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with the aesthetic result of the scar	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich & University of Zurich; 🇨🇭 Zürich, ZH, Switzerland