PREventing Surgical Site occurrences using negative pressURE wound therapy - The PRESSURE Trial

Academisch Medisch Centrum0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•In order to participate in this trial, a subject must meet the following
•>=18 years
•Informed consent
•Pre-operative CT available (< 12 months of surgery)
•Scheduled for elective, open abdominal wall reconstruction*, And one of the
•A stoma** or enterocutaneous fistula and an abdominal wall defect*** of >6
•cm**** on CT
•Violation of the gastrointestinal tract and an abdominal wall defect of >6 cm
•Infected or exposed mesh (any size)
•Open abdomens with contamination***** (any size), * Operative treatments
•may include transversus abdominis release, endoscopic external oblique release
•or open external oblique release, as long as the abdominal wall reconstruction
•is open. Reconstructions incorporating the pedicled or free transfer of tissue
•(e.g. an antero-lateral thigh or latissimus dorsi flap) are included as well.
•, ** This includes jejunostomy, ileostomy, colostomy and Bricker stomata. ,
•*** Abdominal wall defect is defined as:
•**any abdominal wall gap with or without a bulge perceptible by imaging*
•This definition is a modification of the definition proposed by the EHS for
•incisional hernia recurrence., ****In case of parastomal hernia and the patient
•is candidate for ostomy takedown or relocation, the resulting defect in the
•abdominal wall should be taken for this measure, ***** Contamination is defined
•as CDC Surgical Wound Class II (potentially contaminated) to IV
•(dirty/infected).

•Patients <18
•Parastomal hernias planned for reconstruction using a local (or laparoscopic)
•approach without a laparotomy*, *In case of a patient scheduled for
•reconstruction of both incisional hernia and a parastomal hernia, the
•reconstruction of the incisional hernia will be eligible for randomization. If
•a parastomal hernia is approached through a laparotomy, the laparotomy incision
•will be eligible for randomization.

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