A preliminary evaluation of in vivo response to a filament-wound macroporous collagen midurethral sling in an ovine model.

A preliminary evaluation of in vivo response to a filament-wound macroporous collagen midurethral sling in an ovine model.
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DOI:
10.1002/jbm.b.35120
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发表时间:
2022-12
影响因子:
3.4
通讯作者:
Hijaz, Adonis K.
Hijaz, Adonis K.
中科院分区:
工程技术3区
文献类型:
--
作者:
Khalifa, Ahmad O.;Isali, Ilaha;Celik, Hakan;Mastran, Michael;McClellan, Phillip;Gillespie, Callan;Shankar, Subba;MacLennan, Gregory T.;Anderson, James M.;Schumacher, Fredrick R.;Akkus, Ozan;Hijaz, Adonis K.

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压力性尿失禁(Stress urinary incontinence, SUI)影响约1/3的50岁以上女性。关于PP网用于骨盆脱垂修复的负面宣传推动了对SUI修复替代生物材料的需求。我们的研究评估了在羊模型中植入胶原绷带的体内反应。电压实胶原蛋白线以细丝缠绕成吊带,并在genipin中交联。胶原蛋白吊带被植入皮下模仿阴道带技术。主要研究组为:胶原蛋白吊带(n = 3、6个月)和PP吊带(n = 3、6个月)。胶原绷带也在3周(n = 1)时进行测试以观察早期组织反应,并在1年(n = 2)时进行测试以评估生物材料的初步寿命。胶原蛋白绷带在6个月愈合为纤维韧带结构,并维持这种结构至1年。组织学评分显示胶原蛋白吊带的生物相容性反应,无不良事件。所有研究组在所有时间点均表现出完整的组织长入和间质新生胶原沉积。胶原线诱导有序的新生胶原沉积,沿胶原线长轴排列。6个月和12个月外植的组织浸润胶原蛋白吊带与阴道、筋膜和PP (Lynx)吊带的结构强度相似(p < 0.05)。由于每个时间点的动物数量有限,本初步研究证明在更大的动物样本量中评估胶原蛋白吊带是合理的,特别是在超过1年的持续时间内评估韧带组织反应的持久性。
Stress urinary incontinence (SUI) impacts ~1/3 of women over age 50. Negative publicity around PP meshes used in pelvic prolapse repair drives the need for identifying alternative biomaterials for SUI repair. Our study evaluated in vivo response to collagen sling implanted in an ovine model. Electrocompacted collagen threads were filament wound as slings and crosslinked in genipin. Collagen slings were implanted suburethrally mimicking the transvaginal tape technique. Main study groups were: Collagen sling (n = 3, 6 months) and PP sling (n = 3, 6 months). Collagen sling was also tested at 3-weeks (n = 1) to observe early-stage tissue response and 1-year (n = 2) to assess biomaterial longevity in a preliminary capacity. Collagen slings healed to a fibrous ligament texture at 6 months and maintained such texture to 1 year. Histological scoring indicated biocompatible responses to collagen slings with no adverse events. All study groups exhibited complete tissue ingrowth and interstitial de novo collagen deposition at all time points. Collagen threads induced orderly de novo collagen deposition that was aligned along long axes of threads. Tissue infiltrated collagen slings that were explanted at 6 and 12 months presented similar structural strength with native tissues such as vagina and fascia, and PP (Lynx) slings (p > .05). With the limitation of low number of animals per time point in hindsight, this preliminary study justifies evaluation of collagen slings in a larger sample size of animals, particularly to assess persistence of ligamentous tissue response over longer durations than 1-year.
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