Clinical trial NCT03755349: Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematoma, Subdural, Chronic
Hematoma, Subdural, Intracranial
Haematoma;Subdural;Traumatic
Keywords: Burr hole cover
Chronic subdural hematoma
Trepanation
Aesthetic outcome
Complications
Patient satisfaction
Burr hole plate
Scar
Skin depression
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2018-11-27
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction with the aesthetic result of the scar
timeFrame: 90 days postoperative +/- 10 days
Secondary outcomes:
measure: Patient satisfaction with the aesthetic result of the scar
timeFrame: 12 months postoperative +/- 30 days
measure: Impairment in activities of daily living
timeFrame: 90 days and 12 months postoperative
measure: Skin depression
timeFrame: 90 days and 12 months postoperative
measure: EQ-5D Index
timeFrame: 90 days and 12 months postoperative
measure: EQ-5D VAS
timeFrame: 90 days and 12 months postoperative
measure: Neurological outcome
timeFrame: 90 days postoperative
measure: Disability
timeFrame: 90 days postoperative
Other outcomes:
measure: Home time
timeFrame: 90 days and 12 months postoperative
measure: Safety Outcome - intraoperative complication
timeFrame: Day of surgery
measure: Safety Outcome - postoperative complication
timeFrame: 90 days and 12 months postoperative
measure: Safety Outcome - hematoma recurrence
timeFrame: 90 days and 12 months postoperative
measure: Safety Outcome - local wound infection
timeFrame: 90 days and 12 months postoperative
measure: Radiological Outcome - residual hematoma volume
timeFrame: 90 days postoperative
measure: Radiological Outcome - absolute hematoma clearance
timeFrame: 90 days postoperative
measure: Radiological Outcome - relative hematoma clearance
timeFrame: 90 days postoperative
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich & University of Zurich
state: ZH
Study officials:
affiliation: University of Zurich & University Hospital Zurich
name: Martin N Stienen, MD, FEBNS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich & University Hospital Zurich
name: Luca Regli, MD
role: STUDY_CHAIR
affiliation: Universitätsspital Zürich
name: Menno R Germans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.