Efficacy and safety of RD2 Ver.02, a whole blood clot therapy, coupled with a minimally invasive procedure in pilonidal sinus: a phase II study.

BACKGROUND: PNS is caused by an infection in the sacrococcygeal area triggered by hair particle accumulation in skin tunnels, resulting in infection. Surgical options range from simple excision to complex flap constructions. Primary wound healing failure and recurrence rates contribute to the burden of PNS. RD2 Ver.02, a novel autologous whole-blood clot product, demonstrated safety and efficacy in treating complex cutaneous wounds and was investigated for the management of PNS. METHODS: A Phase II open-label, pilot, single-arm prospective study was conducted from May 2021 to May 2023 (Ethics Committee approval #7952-20). Patients with PNS underwent a minimally invasive trephine procedure under local anesthesia followed by RD2 Ver.02 instillation into the cavity. Primary healing was assessed at 3, 6, and 12 months. Secondary outcomes included the collection of adverse events. RESULTS: Overall, 51 patients participated in the study. At 3 months, 42/51 healed (82.4%), 7/51 (13.7%) were granulating but not completely healed, and 2/51 (3.9%) failed to heal. At 6 and 12 months, 46/51 (90.2%) and 42/51 (82.4%) achieved complete healing, respectively. At 6 months, two PNSs recurred after initial healing and an additional four instances of PNS recurrence observed in 12 months, so a total of recurrence in six patients (11.8%). There were five adverse events (AEs) with no severe adverse events. CONCLUSION: RD2 Ver.02 is a safe and effective treatment of PNS when coupled with a minimally invasive trephine PNS procedure. Further comparative studies are needed to fully assess the role of this novel therapy for PNS.

Comparison between the use of subdural and subgaleal drainage in treatment of chronic subdural hematoma.

BACKGROUND AND OBJECTIVES: Chronic subdural hematoma (CSDH) is one of the most common pathologies in our daily practice. The standard treatment is the evacuation making a burr-hole and placement of a subdural drainage, which has shown to decrease its recurrence. However, this procedure can entail risks such as parenchymal damage, infection, or the onset of seizures, prompting the consideration of subgaleal drainage as an alternative. Our objective is to compare the use of subdural and subgaleal drainage in a cohort of patients undergoing intervention for CSDH, as well as to analyze the differences in complication rates and recurrence between the two groups. METHODOLOGY: A retrospective analytical observational study was conducted, analyzing 152 patients diagnosed with CSDH who underwent intervention at our center from January 2020 to April 2022. Patients in whom drainage was not placed were excluded. In all patients, a burr-hole was performed and the type of drainage was chosen by the neurosurgeon. RESULTS: Out of the 152 patients, subdural drainage was placed in 80 cases (52.63%), while subgaleal drainage was used in 72 cases (47.37%). There were no significant differences in the recurrence rate (30% in the subdural drainage group vs. 20.83% in the subgaleal drainage group; P = .134) or in the complication rate (7.5% in the subdural drainage group vs. 5.5% in the subgaleal drainage group; P = .749). CONCLUSIONS: Subgaleal drainage shows similar clinical outcomes with a recurrence and complication rate comparable to subdural drainage, suggesting it as a safe and effective alternative to subdural drainage in the treatment of CSDH.

Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): a Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial.

BACKGROUND: Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed. METHODS: The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4-6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed. FINDINGS: From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2-11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4-6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%]). INTERPRETATION: We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation. FUNDING: State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden.

Quantitative Assessment of Brain Expansion After Evacuation of Chronic Subdural Hematoma as a Predictor of Recurrence.

BACKGROUND: A lack of brain expansion is considered a risk factor for recurrence after evacuation of a chronic subdural hematoma (CSDH). To the best of our knowledge, no studies have reported on objective measurement of brain expansion after evacuation of a CSDH. METHODS: We performed a retrospective analysis of prospectively collected data of patients undergoing 2 burr hole evacuation of a CSDH. We measured the depth of the brain surface from the frontal burr hole dural opening after hematoma evacuation using a specially devised measuring tool. Other predictors analyzed for recurrence of hematoma were age, gender, a history of hypertension, the use of anticoagulant and/or antiplatelet agents, Glasgow coma scale score at presentation, unilateral or bilateral hematoma, computed tomography appearance, and hematoma thickness. RESULTS: Among 88 patients who underwent hematoma evacuation, 3 (3.4%) underwent surgery for recurrence. The significant factors associated with recurrence were the presence of bilateral hematoma (P = 0.001), hematoma width >2.3 cm (P = 0.04), gradation type of hematoma on the computed tomography scan (P = 0.03), and the depth of the brain after hematoma evacuation (P = 0.02). The brain expanded less in those with recurrence, with a mean depth of the brain of 18 ± 6 mm versus 7.27 ± 7.8 mm in those without recurrence. CONCLUSIONS: Evacuation of a CSDH through 2 burr holes, along with copious irrigation and bed rest for 3 days, resulted in a very low recurrence rate without the use of a drain. A lack of brain expansion might be a predictor of recurrence. To the best of our knowledge, this is the first study to quantitatively measure the depth of the brain at surgery in patients undergoing surgery for CSDH.

Acute-to-chronic subdural hematoma: radiographic and clinical progression from acute subdural hematoma.

INTRODUCTION: The pathogenesis of chronic subdural hematoma (CSDH) has not been completely understood. However, different mechanisms can result in space-occupying subdural fluid collections, one pathway can be the transformation of an original trauma-induced acute subdural hematoma (ASDH) into a CSDH. MATERIALS AND METHODS: All patients with unilateral CSDH, requiring burr hole trephination between 2018 and 2023 were included. The population was distributed into an acute-to-chronic group (group A, n = 41) and into a conventional group (group B, n = 282). Clinical and radiographic parameters were analyzed. In analysis A, changes of parameters after trauma within group A are compared. In analysis B, parameters between the two groups before surgery were correlated. RESULTS: In group A, volume and midline shift increased significantly during the progression from acute-to-chronic (p < 0.001, resp.). Clinical performance (modified Rankin scale, Glasgow Coma Scale) dropped significantly (p = 0.035, p < 0.001, resp.). Median time between trauma with ASDH and surgery for CSDH was 12 days. Patients treated up to the 12th day presented with larger volume of ASDH (p = 0.012). Before burr hole trephination, patients in group A presented with disturbance of consciousness (DOC) more often (p = 0.002), however less commonly with a new motor deficit (p = 0.014). Despite similar midline shift between the groups (p = 0.8), the maximal hematoma width was greater in group B (p < 0.001). CONCLUSION: If ASDH transforms to CSDH, treatment may become mandatory early due to increase in volume and midline shift. Close monitoring of these patients is crucial since DOC and rapid deterioration is common in this type of SDH.

Feasibility, Clinical Potential, and Limitations of Trans-Burr Hole Ultrasound for Postoperative Evaluation of Chronic Subdural Hematoma: A Prospective Pilot Study.

BACKGROUND AND OBJECTIVES: Chronic subdural hematoma (CSDH) is commonly managed through burr hole surgery. Routine follow-up using computed tomography (CT) imaging is frequently used at many institutions, contributing to significant radiation exposure. This study evaluates the feasibility, safety, and reliability of trans-burr hole sonography as an alternative postoperative imaging modality, aiming to reduce radiation exposure by decreasing the frequency of CT scans. METHODS: We conducted a prospective pilot study on 20 patients who underwent burr hole surgery for CSDH. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness under the burr hole sonographically compared with CT, the occurrence of complications, and the potential factors affecting sonographic image quality. The Pearson correlation coefficient was used to demonstrate relationships between CT and ultrasound and axial and coronal ultrasound. RESULTS: Sonography through the burr hole was feasible in 73.5% of cases, providing measurements of residual fluid that closely paralleled CT findings, with an average discrepancy of 1.2 mm for axial and 1.4 mm for coronal sonographic views. A strong positive correlation was found between axial and coronal ultrasound ( r = 0.955), CT and axial ultrasound ( r = 0.936), and CT and coronal ultrasound ( r = 0.920). The primary obstacle for sonographic imaging was the presence of air within the burr hole or the subdural space, which typically resolved over time after surgery. CONCLUSION: Trans-burr hole sonography emerges as a promising technique for postoperative monitoring of CSDH, with the potential to safely reduce reliance on CT scans and associated radiation exposure in selected patients. Our results support further investigation into the extended use of sonography during the follow-up phase. Prospective multicenter studies are recommended to establish the method's efficacy and to explore strategies for minimizing air presence postsurgery.

Recurrence rates of pilonidal sinus disease in the pediatric population following trephine surgery.

BACKGROUND: Pilonidal sinus disease (PSD) is a common surgical disease. Multiple surgical methods exist in the literature, without clear consensus regarding which should be the first-line treatment. Minimally invasive methods such as the Gips procedure are gaining popularity in recent years. The aim of our study was to assess recurrence rates following the Gips procedure and to determine whether using the same surgical approach during re-operation is efficient and successful. METHODS: This is a single-center retrospective observational study of pediatric patients that underwent Gips procedure due to PSD between the years 2012-2022. RESULTS: 565 pediatric patients underwent an elective surgery for PSD in the study period. Recurrence rate was 8.1% (n = 46). In all the patients with recurrence, re-operation took place on average 9 months following the first surgery and using the same surgical method. Following the second surgery, only 8 patients (1%) had multiple recurrences. CONCLUSIONS: We found a relatively low recurrence rate in the pediatric population using the Gips method, and nearly 100% success rate following the second operation. Our findings set a new benchmark for pediatric recurrence following PSD operation, with clear recommendation to use the same method of surgery upon further recurrences as well.

Contralateral Nasofrontal Trephination: A Novel Corridor for a "Dual Port" Approach to the Petrous Apex.

BACKGROUND AND OBJECTIVES: Expanded endonasal approaches (EEAs) have proven safe and effective in treating select petrous apex (PA) pathologies. Angled endoscopes and instruments have expanded indications for such approaches; however, the complex neurovascular anatomy surrounding the petrous region remains a significant challenge. This study evaluates the feasibility, anatomic aspects, and limitations of a contralateral nasofrontal trephination (CNT) route as a complementary corridor improving access to the PA. METHODS: Expanded endonasal and CNT approaches to the PA were carried out bilaterally in 15 cadaveric heads with endovascular latex injections. The distance to the PA, angle between instruments through the 2 approach portals, and surgical freedom were measured and compared. RESULTS: Three-dimensional DICOM-based modeling and visualization indicate that the CNT route reduces the distance to the target located within the contralateral PA by an average of 3.33 cm (19%) and affords a significant increase in the angle between instruments (15.60°; 54%). Furthermore, the vertical vector of approach is improved by 28.97° yielding a caudal reach advantage of 2 cm. The area of surgical freedom afforded by 3 different approaches (endonasal, endonasal with an endoscope in CNT portal, and endonasal with an instrument in CNT portal) was compared at 4 points: the dural exit point of the 6th cranial nerve, jugular foramen, foramen lacerum, and petroclival fissure. The mean area of surgical freedom provided by both approaches incorporating the CNT corridor was superior to EEA alone at each of the surgical targets ( P = <.001). CONCLUSION: The addition of a CNT portal provides an additional avenue to expand on the classical EEA to the PA. This study provides insight into the anatomic nuances and potential clinical benefits of a dual-port approach to the PA.

The Lenticular.

OBJECTIVE: The lenticular was an instrument introduced by Galen to facilitate cutting the bone of the cranium. Illustrations of the instrument first appeared in the 16th century during the Renaissance. These illustrations have been widely used, but the instrument's shape seems ill-adapted to its function. Archaeological research in Rimini, Italy, unearthed a similar instrument with a shape that seems more suitable for the function of cutting cranial bone. The object of this study was to evaluate the efficacy of these two instruments for cutting the bone of the cranium. METHODS: Replicas of the two instruments were obtained. Trepanation was performed in the left parietal region of a sheep's head. In addition, the application of the instruments in the literature was analyzed. RESULTS: The Roman lenticular cut the cranium with ease. The Renaissance instrument failed to cut the bone and only separated the dura mater from the bone. The lenticular had been used to cut bone up to the 13th century. In contrast, the Renaissance instrument was not used to cut bone but to smooth roughened bony surfaces and to remove spicules of bone that were in contact with the dura. CONCLUSIONS: Analysis of illustrations in medical publications should be undertaken with the same rigor as applied to analysis of text.

Efficacy and safety of bedside percutaneous three-millimeter twist-drill trephination under local anesthesia-a retrospective study of 1000 patients.

PURPOSE: Percutaneous 3-mm twist-drill trephination (TDT) under local anesthesia as a bedside operative technique is an alternative to the conventional open surgical trephination in the operating theatre. The aim of this study was to verify the efficacy and safety of this minimal invasive procedure. METHODS: This retrospective study comprises 1000 patients who were treated with TDT under local anesthesia at bedside due to chronic subdural hematoma (cSDH), intracerebral hemorrhage (ICH), and hydrocephalus (HYD) as a result of subarachnoid hemorrhage or non-hemorrhagic causes, increased intracranial pressure (IIP) in traumatic brain injury or non-traumatic brain edema, and other pathologies (OP) requiring drainage. Medical records, clinical outcome, and results of pre- and postoperative computed tomography (CT) and/or magnetic resonance tomography (MRT) were analyzed. RESULTS: Indications for TDT were cSDH (n = 275; 27.5%), ICH (n = 291; 29.1%), HYD (n = 316; 31.6%), IIP (n = 112; 11.2%), and OP (n = 6; 0.6%). Overall, primary catheter placement was sufficient in 93.8% of trephinations. Complication rate was 14.1% and mainly related to primary catheter malposition (6.2%), infections (5.2%), and secondary hemorrhage (2.7%); the majority of which were clinically inapparent puncture channel bleedings not requiring surgical intervention. The revision rate was 13%. CONCLUSIONS: Bedside TDT under local anesthesia has proven to be an effective and safe alternative to the conventional burr-hole operative technique as usually performed under general anesthesia in the operation theatre, and may be particularly useful in emergency cases as well as in elderly and multimorbid patients.