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Subgroup analysis aims to identify subgroups (usually defined by baseline/demographic characteristics), who would (or not) benefit from an intervention under specific conditions. Often performed post hoc (not pre-specified in the protocol), subgroup analyses are prone to elevated type I error due to multiple testing, inadequate power, and inappropriate statistical interpretation. Aside from the well-known Bonferroni correction, subgroup treatment interaction tests can provide useful information to support the hypothesis. Using data from a previously published randomized trial where a p value of 0.015 was found for the comparison between standard and Hemopatch® groups in (the subgroup of) 135 patients who had hand-sewn pancreatic stump closure we first sought to determine whether there was interaction between the number and proportion of the dependent event of interest (POPF) among the subgroup population (patients with hand-sewn stump closure and use of Hemopatch®), Next, we calculated the relative excess risk due to interaction (RERI) and the "attributable proportion" (AP). The p value of the interaction was p = 0.034, the RERI was − 0.77 (p = 0.0204) (the probability of POPF was 0.77 because of the interaction), the RERI was 13% (patients are 13% less likely to sustain POPF because of the interaction), and the AP was − 0.616 (61.6% of patients who did not develop POPF did so because of the interaction). Although no causality can be implied, Hemopatch® may potentially decrease the POPF after distal pancreatectomy when the stump is closed hand-sewn. The hypothesis generated by our subgroup analysis requires confirmation by a specific, randomized trial, including only patients undergoing hand-sewn closure of the pancreatic stump after distal pancreatectomy. Trial registration: INS-621000-0760. [ABSTRACT FROM AUTHOR]

Purpose: Uterine myomas are the most common gynecological disease. In these cases, a myomectomy is performed traditionally laparotomically. However, alternatives have been widely used, including laparoscopic, endoscopic, and robotic surgery. During these techniques, diffuse parenchymatous bleeding remains one of the main intraoperative and postoperative complications and sometimes requires unplanned hysterectomies. Recently, hemostatic agents and sealants have been used to prevent excessive blood loss during surgical repair. Methods: We propose a prospective case–control study on the use of a sealing hemostat patch (HEMOPATCH®) on uterine sutures in laparotomic myomectomy. In the period between July 2016 and April 2017, 46 patients with symptomatic uterine fibromatosis underwent surgery. They were divided into two groups of 23 patients, with different treatments in the hemostatic phase of oozing bleeding. HEMOPATCH® is applied in group A, and spray electrocoagulation is applied in group B. Results: In group A, we achieve faster hemostasis (p < 0.05), than in group B. We report a significantly lower C-reactive protein value on the second and third days after surgery for group A compared to group B. Conclusions: HEMOPATCH®, during laparotomic myomectomy, is a valid alternative solution for obtaining rapid hemostasis and consequently intraoperative and postoperative bleeding. Furthermore, we suggest that a lower inflammatory peritoneal state is probably correlated with the barrier effect of the patch on the suture. [ABSTRACT FROM AUTHOR]

Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662. [ABSTRACT FROM AUTHOR]

Abstract Surgery of complex cranial base lesions carries a high risk of damage to main vessels, often resulting in life-changing or even life-threatening injuries. We describe a rapid, effective, and noninvasive application of a collagen-based hemostatic patch to repair the vertebral artery during cranial surgery. A 61-year-old male patient underwent retrosigmoid craniotomy to remove a foramen magnum meningioma that encased the vertebral artery. A linear incision was made behind the ear and standard retrosigmoid craniotomy was performed with preservation of the transverse and sigmoid sinuses. The dura was opened in a Y-shaped fashion and the cerebellum was retracted with cerebrospinal fluid being released. Removing the exposed tumor from the artery resulted in a small arterial bleed. Two pieces of an N-hydroxysuccinimide-functionalized polyethylene glycol-coated collagen patch (Hemopatch®, Baxter Healthcare Ltd.) were applied sequentially and were pressed to the bleed site for 2 min each. Hemostasis of the vertebral artery was achieved at the patient’s regular blood pressure. There was no postoperative bleeding, dissection or pseudoaneurysm. The patient recovered gradually with several cranial nerve deficits. There was no brain stem stroke. Twelve months on, the patient has made an excellent recovery from surgery, is independently mobile and has minimal cranial nerve deficits. Application of the collagen-based hemostatic patch proved to be an efficient, safe, and noninvasive technique that achieved rapid hemostasis, confirming its effectiveness in complicated surgery, where risk of hemorrhage can be critical for the surgery outcome. Funding: There was no funding for this case report. Baxter Healthcare Ltd. provided funding for preparation of this manuscript and the journal’s Rapid Service Fee.

• First report on Hemopatch® with fibrin glue as a dural sealant in neurosurgery. • First literature review about the use of Hemopatch® in neurosurgery. • No CSF leak, no postoperative infection, no adverse reaction in this series. • Using Hemopatch® with fibrin glue is safe and viable in cranial and spine surgery. A major complication in cranial and spinal surgery is the post-operative occurrence of a cerebrospinal fluid (CSF) leak. Here we reported a technical note firstly describing the use of Hemopatch® with fibrin glue as a dural sealant in cranial and spinal neurosurgical procedures. Moreover we carried out a review of the literature. Further to the best of our knowledge this was the first series including patients submitted to different spinal surgeries in whom Hemopatch® was used as dural sealant. We prospectively collected the data of 22 patients. In all procedures, fibrin glue was applied after Hemopatch®. The mean age was 59.68 ± 10.79 years and the mean follow-up (FU) was 3.63 ± 1.46 months, respectively. Overall, Hemopatch® with fibrin glue was used in 8 cranial procedures (36.36%; all were retrosigmoid craniotomies) and 14 spinal procedures (63.64%). 9/14 spinal cases (64.28%) were incidental durotomies during a spinal decompression procedure. No CSF leak, no postoperative infection, no adverse reaction were observed during the FU in all cases. The literature search revealed only two retrospective series, reporting only patients submitted to cranial surgery for a total of 56 patients and a CSF leak occurring in 3 patients (5.35%). In conclusion, we firstly reported the feasibility and the safety of using Hemopatch® with fibrin glue as dural sealant in cranial surgery and different spinal procedures. Further larger comparative studies are needed to confirm our initial encouraging results. [ABSTRACT FROM AUTHOR]

Surgery of complex cranial base lesions carries a high risk of damage to main vessels, often resulting in life-changing or even life-threatening injuries. We describe a rapid, effective, and noninvasive application of a collagen-based hemostatic patch to repair the vertebral artery during cranial surgery. A 61-year-old male patient underwent retrosigmoid craniotomy to remove a foramen magnum meningioma that encased the vertebral artery. A linear incision was made behind the ear and standard retrosigmoid craniotomy was performed with preservation of the transverse and sigmoid sinuses. The dura was opened in a Y-shaped fashion and the cerebellum was retracted with cerebrospinal fluid being released. Removing the exposed tumor from the artery resulted in a small arterial bleed. Two pieces of an N-hydroxysuccinimide-functionalized polyethylene glycol-coated collagen patch (Hemopatch®, Baxter Healthcare Ltd.) were applied sequentially and were pressed to the bleed site for 2 min each. Hemostasis of the vertebral artery was achieved at the patient's regular blood pressure. There was no postoperative bleeding, dissection or pseudoaneurysm. The patient recovered gradually with several cranial nerve deficits. There was no brain stem stroke. Twelve months on, the patient has made an excellent recovery from surgery, is independently mobile and has minimal cranial nerve deficits. Application of the collagen-based hemostatic patch proved to be an efficient, safe, and noninvasive technique that achieved rapid hemostasis, confirming its effectiveness in complicated surgery, where risk of hemorrhage can be critical for the surgery outcome. Funding: There was no funding for this case report. Baxter Healthcare Ltd. provided funding for preparation of this manuscript and the journal's Rapid Service Fee. [ABSTRACT FROM AUTHOR]

Background and objectives Cerebrospinal fluid (CSF) leakage is a significant complication in cranial and spinal interventions. Hemostatic patches such as Hemopatch ® are therefore used to support the watertight closure of the dura mater. Recently, we published the results of a large registry documenting the effectiveness and safety of Hemopatch ® in various surgical specialties, including neurosurgery. Here we aimed to analyze the outcomes from the neurological/spinal cohort of this registry in more detail. Methods Based on the data from the original registry, we performed a post hoc analysis for the neurological/spinal cohort. The Hemopatch ® registry was designed as a prospective, multicenter, single-arm observational study. All surgeons were familiar with the application of Hemopatch ® and it was used at the discretion of the responsible surgeon. The neurological/spinal cohort was open for patients of any age if they had received Hemopatch ® during an open or minimally invasive cranial or spinal procedure. Patients with known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile severe bleeding, or an active infection at the potential target application site (TAS) were excluded from the registry. For the posthoc evaluation, we stratified the patients of the neurological/spinal cohort into two sub-cohorts: cranial and spinal. We collected information about the TAS, intraoperative achievement of watertight closure of the dura, and occurrence of postoperative CSF leaks. Results The registry comprised 148 patients in the neurological/spinal cohort when enrolment was stopped. The dura was the application site for Hemopatch ® in 147 patients (in one patient in the sacral region after tumor excision), of which 123 underwent a cranial procedure. Twenty-four patients underwent a spinal procedure. Intraoperatively, watertight closure was achieved in 130 patients (cranial sub-cohort: 119; spinal sub-cohort: 11). Postoperative CSF leakage occurred in 11 patients (cranial sub-cohort: nine; spinal sub-cohort: two). We observed no serious adverse events related to Hemopatch ® . Conclusion Our post hoc analysis of real-world data from a European registry confirms the safe and effective use of Hemopatch ® in neurosurgery, including cranial and spinal procedures, as also observed in some case series., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Schebesch et al.)

Background: Dural repair is a potential source of complications in neurosurgery. We make a comparison in pseudomeningocele and CSF leak incidence with the sealants Tisseel® and Hemopatch®., Methods: We collected 147 patients from September 2017 to December 2018 in a prospective observational study. Inclusion criteria were adult patients with an intradural cranial or spinal surgery whose dura was closed with a fibrin sealant. Primary endpoints were the incidence of pseudo meningocele and CSF leak. Secondary endpoints were the surgical-site infection, epidural hematoma, and the influence of previous surgery., Results: In 65 and 82 patients Tisseel® and Hemopatch® were used as sealants respectively. The incidence of CSF leak presented a significant statistical relation with the use of Tisseel® in a univariate and multivariate analysis. Infratentorial surgery presented a higher incidence of pseudomeningocele and CSF leak, but the approach used was not a significant factor in multivariate analysis. Patients who were operated previously had a higher risk present a postoperative complication., Conclusions: The incidence of pseudomeningocele and CSF leak was higher with Tisseel® compared with Hemopatch® with a statistic significant relation in case of CSF fistulae. The procedure done may be a confusion factor in our study. There was no report of adverse effects or a higher incidence of complications. However, it is recommended to plan randomized trials with larger samples to get stronger evidence., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)