Stopped: Financial
The proposed project aims to evaluate the safety of DuraMesh™ suture for laparotomy closure in an emergent setting, while also providing preliminary efficacy data with regard to incisional hernia prevention. Conventional techniques for laparotomy closure in the setting of an emergency laparotomy or delayed abdominal closure suffer from a lack of durability, with incisional hernia rates of 30-34% reported. While prophylactic planar mesh placement has emerged as a cost-effective strategy to prevent hernia formation in the clean, elective laparotomy setting, higher rates of surgical site complications and increased technical complexity preclude its use in the emergency or contaminated setting. Utilized exactly like conventional suture without any change in surgical closure technique, DuraMesh™ provides the durability of planar mesh reinforcement without the marked increase in foreign material or added surgical complexity. As a result, DuraMesh™ is the only hernia prevention strategy that can be forward-deployed in support of the injured warfighter. While this study is specifically targeted to a gap in the care of the injured warfighter, the potential benefits extend well beyond the military applications. With over 2 million laparotomies performed annually in the United States, and approximately 20% of these resulting in an incisional hernia, the need for an alternative abdominal wall closure strategy is equally dire in the civilian setting. This clinical trial represents an opportunity to drive the needed paradigm shift towards prevention, rather than costly management of incisional hernias. The investigators anticipate this work will rapidly lead to further research, including providing the preliminary data necessary to launch a multi-center randomized controlled trial to assess the clinical efficacy of DuraMesh™ for hernia prevention in both the emergent and elective operative settings.
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Rate of surgical site infection
Timeframe: 30 days