Preliminary study with SprayShield™ Adhesion Barrier System in the prevention of abdominal adhesions.
Preliminary study with SprayShield™ Adhesion Barrier System in the prevention of abdominal adhesions.
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DOI：
10.5114/wiitm.2011.34884
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发表时间：
2013-12
期刊：
影响因子：
--
通讯作者：
Krokowicz P
中科院分区：
文献类型：
--
作者：
Banasiewicz T;Horbacka K;Karoń J;Malinger S;Antos F;Rudzki S;Kala Z;Stojcev Z;Kössi J;Krokowicz P
腹膜粘连，即手术后腹膜腔表面之间形成的纤维化带，仍然是一个艰巨的临床挑战。评估 SprayShield™ 粘连屏障系统（PEG 酯胺溶液和缓冲溶液）在减少术后粘连形成方面的作用。这是一项前瞻性、多中心、随机、单盲研究。总共 11 名被诊断患有溃疡性结肠炎 (UC) 或家族性腺瘤性息肉病 (FAP) 的受试者被随机分配：8 名进入 SprayShield™ 组，3 名进入对照组。 SprayShield™ 直接涂抹在腹膜中线切口下方和回肠造口部位的内脏上。在后续手术期间，评估术后粘连形成的发生率、范围和严重程度，以及活动回肠环所需的时间。与对照受试者 (NS) 相比，接受 SprayShield™ 治疗的患者在回肠造口闭合处动员回肠环所需的时间稍短，粘连的发生率和严重程度也稍低。 SprayShield™ 易于使用、安全、快速应用，并且在粘附性和一致性方面表现良好。与对照受试者相比，SprayShield™ 受试者的粘连发生率和严重程度较低，但由于患者数量有限，没有足够的数据来证实 SprayShield™ 粘连屏障系统在预防粘连方面的有效性。
Peritoneal adhesions, the fibrotic bands that form between the surfaces in the peritoneal cavity following surgery, still pose a difficult clinical challenge. To evaluate the SprayShield™ Adhesion Barrier System (PEG ester amine solution and a buffer solution) in reducing post-operative adhesion formation. This was a prospective, multi-center, randomized, single blind study. A total of 11 subjects diagnosed with ulcerative colitis (UC) or familial adenomatous polyposis (FAP) were randomized: 8 to the SprayShield™ arm and 3 to the control arm. SprayShield™ was applied on the viscera directly under the midline peritoneal incision and at the site of ileostomy. During the follow-up surgery, the incidence, extent, and severity of post-operative adhesion formation were evaluated, as well as the time required to mobilize the ileal loop. In patients who received SprayShield™ the time required to mobilize the ileal loop at the ileostomy closure was slightly shorter and the incidence and severity of adhesions were somewhat lower vs. control subjects (NS). SprayShield™ was found to be easy to use, safe, and quick to apply, and performed well in adherence and conformity. The incidence and severity of adhesions were lower for SprayShield™ subjects vs. control subjects, but due to the limited number of patients there are not enough data to confirm the effectiveness of the SprayShield™ Adhesion Barrier System in prevention of adhesions.
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影响因子：
1.9
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