Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

Hematoma, Subdural, Chronic Clinical Trial

— CORRECT-SCAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755349
• Other study ID #: BASEC 2018-01180
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 31, 2022
• Est. primary completion date: September 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich & University of Zurich	Zürich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Stryker European Operations BV

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home time	Home time, as surrogate marker of disability	90 days and 12 months postoperative
Other	Safety Outcome - intraoperative complication	Any complication occurring during the surgery	Day of surgery
Other	Safety Outcome - postoperative complication	Any deviation from the regular postoperative course will be recorded on the Clavien-Dindo grading scale.	90 days and 12 months postoperative
Other	Safety Outcome - hematoma recurrence	Hematoma recurrence per side requiring re-operation	90 days and 12 months postoperative
Other	Safety Outcome - local wound infection	Local wound infection requiring surgical revision per side	90 days and 12 months postoperative
Other	Radiological Outcome - residual hematoma volume	Residual hematoma volume in ccm3 will be measured per side on the CT scan routinely performed for clinical patient care	90 days postoperative
Other	Radiological Outcome - absolute hematoma clearance	Absolute (in ccm3) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans	90 days postoperative
Other	Radiological Outcome - relative hematoma clearance	Relative (in %) hematoma clearance per side will be determined by comparing the pre- and postoperative CT scans	90 days postoperative
Primary	Patient satisfaction with the aesthetic result of the scar	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	Patient satisfaction with the aesthetic result of the scar	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
Secondary	Impairment in activities of daily living	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
Secondary	Skin depression	Rate of skin depression, rated as yes vs. no	90 days and 12 months postoperative
Secondary	EQ-5D Index	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
Secondary	EQ-5D VAS	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
Secondary	Neurological outcome	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
Secondary	Disability	Disability, determined by the mRS (ranging from 0 (no disability) to 6 (dead)	90 days postoperative