Reinforced tissue matrix

  • 文章类型: Journal Article
    背景:腹壁缺陷或无力是临时造口术的常见并发症,切口疝常在结肠造口术或回肠造口术后发展。使用合成网加固腹壁已减少了疝气的发生。生物网格也被用来增强愈合,特别是在受污染的条件下。强化组织基质(RTM),其中包括天然细胞外基质的生物支架和用于增加强度/耐久性的合成组件,旨在利用合成和生物材料的各个方面。迄今为止,尚未报道RTM在造口逆转后可增强腹壁。
    目的:评估使用RTM加固造口腹壁的有效性。
    方法:选择28例直肠癌治疗或外伤后接受临时回肠造口术或结肠造口术的造口旁和/或切口疝患者。疝修补和近端造口闭合后,放置RTM(OviTex®1S永久性或OviTex®LPR),以使用腹腔镜增强腹壁,机器人,或开放式手术方法。术后随访1个月和1年。通过体格检查确定疝复发,必要时,通过计算机断层扫描。次要终点包括住院时间,回到工作的时间,再入院。评估的伤口/修复部位的并发症包括手术部位感染的存在,血清肿,血肿,伤口裂开,或瘘管形成。
    结果:观察性研究队列包括16名男性和12名女性患者,平均年龄为58.5岁±16.3岁,平均体重指数为26.2kg/m2±4.1kg/m2。患者出现造口旁疝(75.0%),切口疝(14.3%),或合并造口旁/切口疝(10.7%)。使用腹腔镜(53.6%),机器人(35.7%),或开放式(10.7%)技术,RTM(OviTex®LPR:82.1%,OviTex®1S:17.9%)使用下置式(82.1%)或腹膜内上置式(IPOM;17.9%)网格定位放置。在1个月和1年的随访中,无疝气复发(0%)。平均住院时间为2.1d±1.2d,术后8.3天±3.0天恢复工作。由于网状物感染和/或胃肠道问题,三名患者(10.7%)在1个月随访前再次入院。瘘和网片感染各2例(7.1%),导致一名患者(3.6%)部分网片切除。1个月至1年无并发症(0%)。
    结论:RTM在回肠造口术逆转时成功用于治疗造口旁和切口疝,1个月和1年后无疝气复发和良好结局。
    BACKGROUND: Abdominal wall deficiencies or weakness are a common complication of temporary ostomies, and incisional hernias frequently develop after colostomy or ileostomy takedown. The use of synthetic meshes to reinforce the abdominal wall has reduced hernia occurrence. Biologic meshes have also been used to enhance healing, particularly in contaminated conditions. Reinforced tissue matrices (RTMs), which include a biologic scaffold of native extracellular matrix and a synthetic component for added strength/durability, are designed to take advantage of aspects of both synthetic and biologic materials. To date, RTMs have not been reported to reinforce the abdominal wall following stoma reversal.
    OBJECTIVE: To evaluate the effectiveness of using an RTM to reinforce the abdominal wall at stoma takedown sites.
    METHODS: Twenty-eight patients were selected with a parastomal and/or incisional hernia who had received a temporary ileostomy or colostomy for fecal diversion after rectal cancer treatment or trauma. Following hernia repair and proximal stoma closure, RTM (OviTex® 1S permanent or OviTex® LPR) was placed to reinforce the abdominal wall using a laparoscopic, robotic, or open surgical approach. Post-operative follow-up was performed at 1 month and 1 year. Hernia recurrence was determined by physical examination and, when necessary, via computed tomography scan. Secondary endpoints included length of hospital stay, time to return to work, and hospital readmissions. Evaluated complications of the wound/repair site included presence of surgical site infection, seroma, hematoma, wound dehiscence, or fistula formation.
    RESULTS: The observational study cohort included 16 male and 12 female patients with average age of 58.5 years ± 16.3 years and average body mass index of 26.2 kg/m2 ± 4.1 kg/m2. Patients presented with a parastomal hernia (75.0%), incisional hernia (14.3%), or combined parastomal/incisional hernia (10.7%). Using a laparoscopic (53.6%), robotic (35.7%), or open (10.7%) technique, RTMs (OviTex® LPR: 82.1%, OviTex® 1S: 17.9%) were placed using sublay (82.1%) or intraperitoneal onlay (IPOM; 17.9%) mesh positioning. At 1-month and 1-year follow-ups, there were no hernia recurrences (0%). Average hospital stays were 2.1 d ± 1.2 d and return to work occurred at 8.3 post-operative days ± 3.0 post-operative days. Three patients (10.7%) were readmitted before the 1-month follow up due to mesh infection and/or gastrointestinal issues. Fistula and mesh infection were observed in two patients each (7.1%), leading to partial mesh removal in one patient (3.6%). There were no complications between 1 month and 1 year (0%).
    CONCLUSIONS: RTMs were used successfully to treat parastomal and incisional hernias at ileostomy reversal, with no hernia recurrences and favorable outcomes after 1-month and 1-year.
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  • 文章类型: Journal Article
    目的:根治性膀胱切除术后盆腔器官脱垂的治疗具有挑战性,由于盆底支撑和组织质量受损,一期修复后脱垂的复发很常见。阴道脱垂修复术通常是首选,因为担心患者的复杂腹内病理状况。然而,对于那些在阴道炎后复发性脱垂的人来说,有限的确定治疗方案存在。
    方法:本手术视频介绍了一名64岁的G4P4患者,他有根治性膀胱切除术的病史,并带有印第安纳袋治疗浸润性尿路上皮癌,在阴道镜下两年后出现复发性IV期阴道脱垂。由于阴道组织薄,不能进行带阴道网眼的sacrocolpopexy,因此,该患者接受了机器人辅助的阴道疝修补术,该修补术采用聚丙烯增强的绵羊组织基质附着于Cooper韧带和肛提肌.
    结果:手术没有并发症,她的术后盆腔器官脱垂定量检查显示处女膜水平的阴道组织残留。患者报告了手术后总体改善的健康和生活质量以及术后验证问卷的恢复。
    结论:使用聚丙烯增强的组织基质进行阴道和盆底疝修补术对于先前行根治性膀胱切除术的患者是可行的决定性手术治疗方法。
    OBJECTIVE: Pelvic organ prolapse following a radical cystectomy is challenging to treat and recurrence of prolapse after primary repair is common owing to compromised pelvic floor support and tissue quality. Vaginal prolapse repairs are often preferred because of concern for patients\' complex intraabdominal pathological conditions. However, for those with recurrent prolapse following colpocleisis, limited definitive treatment options exist.
    METHODS: This surgical video presents a 64-year-old G4P4 with a history of radical cystectomy with an Indiana Pouch for invasive urothelial carcinoma who presented with recurrent stage IV vaginal prolapse two years following colpocleisis. Owing to thin vaginal tissue, a sacrocolpopexy with vaginal mesh could not be performed, thus, the patient underwent robotic-assisted vaginal hernia repair with a polypropylene-reinforced ovine tissue matrix attached to Cooper\'s ligament and the levator ani muscles.
    RESULTS: The surgery was free from complications and her postoperative Pelvic Organ Prolapse Quantification examination revealed a leading vaginal tissue remnant at the level of the hymen. The patient reported overall improved health and quality of life following surgery and recovery on postoperative validated questionnaires.
    CONCLUSIONS: Vaginal and pelvic floor hernia repair with a polypropylene-reinforced tissue matrix is a feasible definitive surgical treatment for patients with prior radical cystectomy in whom colpocleisis has failed.
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    文章类型: Journal Article
    未经证实:生物基质用于整形和重建外科手术,以帮助软组织修复的动力学并促进功能性组织形成。人脱细胞真皮基质AlloDerm被广泛使用;然而,它以相对较高的成本提供,和它的真皮组合物可能不能提供理想的重塑支架。OviTex塑料和重建手术(PRS)可吸收和永久是增强的生物基质,其设计有羊前胃基质层,上面绣有少量聚合物以优化生物物理性能。这项研究比较了这些基质在软组织修复的非人灵长类动物模型中的愈合结果。
    UNASSIGNED:将受试物品植入手术产生的全厚度中线腹壁缺损中,并在2、4、12和24周时进行宏观和组织学评价。
    未经证实:OviTexPRS永久性和可再吸收基质均显示较早的宿主细胞浸润,新生血管形成,和胶原蛋白沉积,并在植入后12周时完全重塑到宿主组织中。AlloDerm在早期时间点具有较少的宿主细胞浸润和新血管形成,并且从未完全整合到周围的宿主组织中。AlloDerm和OviTexPRS产品在任何时间点的总体炎症没有统计学差异,尽管OviTex产品中少量的聚合物增强。
    未经鉴定:在灵长类软组织修复模型中,OviTexPRS永久性和可再吸收基质的性能与领先的人无细胞真皮基质相当。OviTexPRS永久性和可再吸收比AlloDerm等替代品便宜,并且在某些软组织修复应用中可能会促进更快的宿主细胞增殖和功能重塑。
    UNASSIGNED: Biologic matrices are used in plastic and reconstructive surgical procedures to aid in the kinetics of soft tissue repair and promote functional tissue formation. The human acellular dermal matrix AlloDerm is widely used; however, it is offered at a relatively high cost, and its dermal composition may not provide an ideal remodeling scaffold. OviTex Plastic and Reconstructive Surgery (PRS) Resorbable and Permanent are reinforced biologic matrices engineered with layers of ovine forestomach matrix embroidered with small amounts of polymer to optimize biophysical performance. This study compared the healing outcomes of these matrices in a non-human primate model of soft tissue repair.
    UNASSIGNED: Animals were implanted with test articles in surgically created full-thickness midline abdominal wall defects and evaluated macroscopically and histologically at 2, 4, 12, and 24 weeks.
    UNASSIGNED: Both OviTex PRS Permanent and Resorbable matrices exhibited earlier host cell infiltration, neovascularization, and collagen deposition and also fully remodeled into the host tissue by 12 weeks post implantation. AlloDerm had less host cell infiltration and neovascularization at early time points and never fully integrated into the surrounding host tissue. There was no statistical difference in overall inflammation between AlloDerm and either OviTex PRS product at any time point, despite small amounts of polymer reinforcement in OviTex products.
    UNASSIGNED: In a primate soft tissue repair model, OviTex PRS Permanent and Resorbable matrices performed comparably with the leading human acellular dermal matrix. OviTex PRS Permanent and Resorbable are less expensive than alternatives like AlloDerm and may promote faster host cell proliferation and functional remodeling in some soft tissue repair applications.
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  • 文章类型: Journal Article
    评估使用聚丙烯增强组织基质的开放式复杂腹壁重建(CAWR)的网状行为和临床结果。
    在2019年6月至2021年1月期间使用永久性聚丙烯增强组织基质(OviTex®)进行开放式CAWR的成年患者的多中心回顾性研究。
    分析了荷兰四家医院的55例连续患者;46例腹疝患者和9例腹部开放患者。大多数腹侧疝患者有一种或多种复杂的合并症(91.3%)和一种或多种复杂的疝特征(95.7%)。大多数程序在(清洁)污染的手术区域中进行(69.6%CDC2-4;41.3%CDC3-4)。所有9例腹部开放的患者均接受了半紧急手术。46例腹疝患者中有12例(26.1%)和9例腹部开放患者中有4例(44.4%)发生了术后手术部位感染,如计算机断层扫描(CT)所证实的那样,与网片直接接触。可疑网状物感染。没有患者需要网片外植术来持续感染网片。在13个月的中位随访中,46例腹疝患者中有4例(8.7%)出现CT证实的疝复发。
    在这项开放性复杂腹壁重建的回顾性研究中,聚丙烯增强的组织基质可以承受感染性并发症,并提供可接受的中期复发率。需要从前瞻性研究中获得更长时间的随访数据来确定进一步的疝气复发风险。
    To assess mesh behaviour and clinical outcomes of open complex abdominal wall reconstruction (CAWR) with the use of a polypropylene reinforced tissue matrix.
    A multicenter retrospective study of adult patients who underwent open CAWR with the use of a permanent polypropylene reinforced tissue matrix (OviTex®) between June 2019 and January 2021.
    Fifty-five consecutive patients from four hospitals in the Netherlands were analysed; 46 patients with a ventral hernia and 9 patients with an open abdomen. Most patients with a ventral hernia had one or more complicating comorbidities (91.3%) and one or more complicating hernia characteristics (95.7%). Most procedures were performed in a (clean) contaminated surgical field (69.6% CDC 2-4; 41.3% CDC 3-4). All nine patients with an open abdomen underwent semi-emergent surgery. Twelve out of 46 patients with a ventral hernia (26.1%) and 4 of 9 patients with an open abdomen (44.4%) developed a postoperative surgical site infection that made direct contact with the mesh as confirmed on computed tomography (CT), suspicious of mesh infection. No patient needed mesh explantation for persistent infection of the mesh. During a median follow-up of 13 months, 4 of 46 ventral hernia patients (8.7%) developed a CT confirmed hernia recurrence.
    Polypropylene reinforced tissue matrix can withstand infectious complications and provides acceptable mid-term recurrence rates in this retrospective study on open complex abdominal wall reconstructions. Longer follow-up data from prospective studies are required to determine further risk of hernia recurrence.
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  • 文章类型: Journal Article
    未经批准:在所有类型的疝气中,大型腹侧疝对患者生活质量影响最大,然而,它们也是最难修复的疝类型,并且并发症发生率很高。本病例系列描述了在具有合并症和伴随手术的复杂患者队列中使用绵羊增强生物制剂修复大型腹侧疝。
    UNASSIGNED:作者在5年的时间内对19例连续的高危患者进行了用绵羊增强生物制剂的桥接修复。在所有情况下,都将增强的生物制品用作底层。
    未经证实:在19名患者中,6人(32%)经历了包括感染在内的手术部位,血清肿,脓肿,瘘管,bioloma,或者肠梗阻.三名患者(16%)复发,其中三分之二的复发发生在手术后6个月内。
    UNASSIGNED:使用绵羊增强组织基质(RTM)的SSO和复发率与其他已发表的使用生物或合成网状增强的桥接修复研究一致或更好。因此,在复杂的大型腹侧疝修补术中应考虑绵羊RTM。
    UNASSIGNED: Of all hernia types, large ventral hernias have the most impact on patient quality of life, however they are also the most difficult type of hernia to repair and are associated with high rates of complications. This case series describes repair of large ventral hernias with an ovine reinforced biologic in a complex patient cohort with comorbidities and concomitant procedures.
    UNASSIGNED: The author performed bridged repair with an ovine reinforced biologic in 19 consecutive high-risk patients over a 5-year period. In all cases the reinforced biologic was used as an underlay.
    UNASSIGNED: Of the 19 patients, six (32%) experienced a surgical site occurrence including infection, seroma, abscess, fistula, bioloma, or bowel obstruction. Three patients (16%) had recurrences with two out of three of the recurrences occurring within 6 months of surgery.
    UNASSIGNED: Rates of SSO\'s and recurrences using ovine reinforced tissue matrix (RTM) were in line with or better than other published studies of bridged repair utilizing biologic or synthetic mesh reinforcement. Ovine RTM\'s should therefore be considered in complex large ventral hernia repairs.
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  • 文章类型: Journal Article
    BACKGROUND: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation.
    METHODS: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded.
    RESULTS: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m2. Hernia defects were <20 × 20 cm, classified as class I-III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence.
    CONCLUSIONS: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.
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  • 文章类型: Journal Article
    Surgical mesh reinforcement of the human abdominal wall has been found to reduce the chance of recurrence in hernia repairs. While traditionally polymer meshes have been used in hernia repair, alternative mesh options have been engineered to prevent the inflammatory foreign body response invoked by polymers. A reinforced tissue matrix (RTM) mesh has been developed by embedding a polymer within a decellularized extracellular matrix. This combination has been attributed to the recruitment of host cells, a pro-healing response, and attenuation of the foreign body response. This has been observed to lead to the regeneration of functional tissue within the repair site that is reinforced by the polymer to offload abdominal pressures over time. This manuscript presents the review of OviTex, an RTM, in several types of hernia repair. The authors have found that the use of RTM in hernia repair is effective in preventing foreign body response, promoting wound healing, and providing reinforcement to lower the risk of hernia recurrence.
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