Van Way C W, Milne L, Freedman W L, Lipscomb B
Surg Gynecol Obstet. 1982 Oct;155(4):529-34.
To evaluate a new low lint, nonwoven surgical sponge material, a prospective, stratified, randomized, single blind study of 232 patients was carried out. Patients studied underwent thoracic, upper abdominal or lower abdominal operations. The new material, in the form of laparotomy pads and sponges, was compared with cotton gauze. Safety of the material was evaluated by a battery of biochemical and hematologic tests. No clinically significant differences were seen. Effectiveness was evaluated by measuring fluid absorption. The new material was significantly more effective than cotton gauze in both configurations studied. Since this article was completed, the sponge material has been refabricated into laparotomy pads which are appreciably softer and more comformable than the study pads. The newest revision has been cleared by the Food and Drug Administration for clinical use.
为评估一种新型低绒毛、非织造手术海绵材料,对232例患者进行了一项前瞻性、分层、随机、单盲研究。所研究的患者接受了胸、上腹部或下腹部手术。将这种以剖腹术垫和海绵形式存在的新材料与棉纱进行了比较。通过一系列生化和血液学检测评估了该材料的安全性。未发现临床上的显著差异。通过测量液体吸收来评估有效性。在所研究的两种形式中,新材料均比棉纱显著更有效。自本文完成以来,这种海绵材料已被重新制作成剖腹术垫,比研究用垫明显更柔软、更贴合。最新版本已获美国食品药品监督管理局批准可用于临床。