Covers to Improve Esthetic Outcome After Surgery for Chronic Subdural Hematoma

NCT03755349 | Completed DMC

• 1 other identifier: BASEC 2018-01180
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient satisfaction with the aesthetic result of the scar

  12 months postoperative +/- 30 days

• Impairment in activities of daily living

  90 days and 12 months postoperative

• Skin depression

  90 days and 12 months postoperative

• EQ-5D Index

  90 days and 12 months postoperative

• EQ-5D VAS

  90 days and 12 months postoperative

Other Outcomes (8)

• Home time

  90 days and 12 months postoperative

• Safety Outcome - intraoperative complication

  Day of surgery

• Safety Outcome - postoperative complication

  90 days and 12 months postoperative

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Placement of burr-hole covers

Control group

ACTIVE COMPARATOR

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.

Other: No placement of burr-hole covers

Interventions

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

Also known as: 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

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 able to communicate (in terms of ability to hear, see, speak and understand)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

University Hospital Zurich & University of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 30155645 BACKGROUND

• 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.

  PMID: 31675709 BACKGROUND

• 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.

  PMID: 31811007 BACKGROUND

• Stienen MN, Akeret K, Vasella F, Velz J, Jehli E, Voglis S, Bichsel O, Smoll NR, Bozinov O, Regli L, Germans MR; CORRECT-SCAR Study Group. COveRs to impRove EsthetiC ouTcome after Surgery for Chronic subdural hemAtoma by buRr hole trepanation-Results of a Swiss Single-Blinded, Randomized Controlled Trial. Neurosurgery. 2023 Dec 7. doi: 10.1227/neu.0000000000002778. Online ahead of print.

  PMID: 38059611 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural, Intracranial; Patient Satisfaction; Cicatrix

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior; Fibrosis

Study Officials

• Martin N Stienen, MD, FEBNS

  University of Zurich & University Hospital Zurich

  PRINCIPAL INVESTIGATOR

• Luca Regli, MD

  University of Zurich & University Hospital Zurich

  STUDY CHAIR

• Menno R Germans, MD, PhD

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: January 29, 2019
• Primary Completion: September 19, 2021
• Study Completion: January 31, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the results are published.
• Access Criteria: IPD will be made available on reasonable request, once the results are published and if approved by the institutional review board (KEK-ZH).

Locations

CH (1)