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

Abstract

IntroductionOutcomes rated on impairment scales are satisfactory after burr hole trepanation for chronic subdural haematoma (cSDH). However, the surgery leads to bony defects in the skull with skin depressions above that are frequently considered aesthetically unsatisfactory by the patients. Those defects could be covered by the approved medical devices (burr hole covers), but this is rarely done today. We wish to assess, whether the application of burr hole covers after trepanation for the evacuation of cSDH leads to higher patient satisfaction with the aesthetical result at 90 days postoperative, without worsening disability outcomes or increasing the complication rate.Methods and analysisThis is a prospective, single-blinded, randomised, controlled, investigator-initiated clinical trial enrolling 80 adult patients with first-time unilateral or bilateral cSDH in Switzerland. The primary outcome is the difference in satisfaction with the aesthetic result of the scar, comparing patients allocated to the intervention (burr hole cover) and control (no burr hole cover) group, measured on the Aesthetic Numeric Analogue scale at 90 days postoperative. Secondary outcomes include differences in the rates of skin depression, complications, as well as neurological, disability and health-related quality of life outcomes until 12 months postoperative.Ethics and disseminationThe institutional review board (Kantonale Ethikkommission Zürich) approved this study on 29 January 2019 under case number BASEC 2018–01180. This study determines, whether a relatively minor modification of a standard surgical procedure can improve patient satisfaction, without worsening functional outcomes or increasing the complication rate. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.Trial registration number NCT03755349.

Aesthetic Reconstruction of an Old Burr Hole Defect Using a Cancellous Bone Chip and a Porous Polyethylene Implant

“…Mineral graft hydroxyapatite is not toxic to the tissues and has osteoconductive properties; however, it is too brittle and is easily resorbed when cerebrospinal fluid or water is present 6,7 . Recently, various materials, including allogenic acellular dermal matrix, have been introduced for immediate burr hole defect reconstruction 1,3 . However, burr hole cover can be applied immediately, followed by burr hole surgery because the shape of burr hole cover should precisely fit the skull defect area.…”

“…Various materials have been proposed to fill such defects, including burr hole covers, autologous bone dust, and allogenic acellular dermal matrix. [1][2][3][4] However, to the best of our knowledge, there are no reports on the reconstruction of decades-old depressed scars from burr hole surgery. Here, we present the case of a patient with an old, depressed scar after burr hole surgery 27 years prior.…”

“…After the brain lesion has improved, the remaining postsurgical scarring can negatively affect the quality of life. Various materials have been proposed to fill such defects, including burr hole covers, autologous bone dust, and allogenic acellular dermal matrix 1–4 . However, to the best of our knowledge, there are no reports on the reconstruction of decades-old depressed scars from burr hole surgery.…”

COveRs to impRove EsthetiC ouTcome after Surgery for Chronic subdural hemAtoma by buRr hole trepanation—Results of a Swiss Single-Blinded, Randomized Controlled Trial

“…The final analysis was conducted according to a previously published statistical analysis plan. 14 Outcome analyses were performed in the intention-to-treat (ITT) principle, which included all randomly assigned patients except for those who withdrew consent for participation, died, or were lost to follow-up. We combined the results obtained in the intervention group (unilateral cSDH) and on the intervention side (bilateral cSDH) and compared them with the results obtained in both the control group and on the control side.…”

Chronic subdural haematoma: the role of peri‐operative medicine in a common form of reversible brain injury

“…While various technical nuances to each procedure are proposed and variably advocated for [68,71], including the number of access points, their location, the use of burr hole covers [72] and the management of membranes [68], the one which demonstrates consistent benefit is the use of a postoperative drain [3]. This appears to approximately halve the rate of symptomatic recurrence, which would otherwise occur in up to one in five cases.…”