A Multicenter, Prospective, Single-Blind, Randomized, Controlled, Study of the Repair of Challenging Abdominal Wall Defects: Strattice TM in abdominal Wall Repair (StaR) - StAR

KCI Europe Holding B.V.0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1) Adult (= > 18 years old)
•2) Wirtten informed consent
•3)Has need a surgical intervention of abdominal wall where:
•a) The abdominal wall defect is considered to be (potentially) contaminated, but there is no manifest infection
•b) Abdominal wall defect of a midline, transverse of Pfannenstiel incision
•c) A significant abdominal wall defect of >= 3cm and < 22 cm in length (along axis of incision), and
•d) In case of open abdomen (skin and fascia open), the viscera have been exposed no longer than 15 days
•e) Is willing and able to return for all schedulded and required study visits

•1) Has, at the time of Randomization (patient readay for abdominal wall closure)
•a) severe systemic sepsis (demonstrable bacteremia and/or endotoxemia with hypo/hyperpyrexia, leukopenia/cytosis, tachypnea or hypocarbia, and/or tachycardia)
•b) frank pus in the wound, a fistula that will not be closed at time of surgery or an intra-abdominal abscess in surgical area,
•c) ongoing necrotizing pancreatitis, or
•2) is on chronic immunosuppresive therapy, or other medication that influences wound healing
•3) Requires only short-term closure (i.e. reentry is anticipated within the next week),
•4) Requires a synthetic, non-absorbable mesh to close the abdominal wall defect
•5) Is unable to undergo general anesthesia
•6) Has serious medical risk factors involving any of the major organ systems such that the Investigator considers there to be serious risk of the subject not completing the study (e.g. AIDS or advanced cancer)
•7) Is participating in another clinical study which may alter the postoperative healing response.
•8) is unable to undergo on MRI scan (due to claustrophobia or other reasons)

发起方

KCI Europe Holding B.V.