DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
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.
This is a multisite randomized control proof-of-concept trial to evaluate the safety of
 DuraMesh™ laparotomy closure in the trauma and emergency laparotomy setting. Approximately
 120 patients will be randomized (2:1) to DuraMesh™ laparotomy closure versus conventional
 suture closure. #1 DuraMesh™ will be provided for patients assigned to the DuraMesh™
 treatment arm. Patients will participate in a one-year follow-up regime (2 weeks,1 month, 3
 months, 6 months and 12 months).

 Primary Laparotomy Closure Treatment 1) Study Group - DuraMesh™ Laparotomy Closure (DLC)
 Treatment 2) Control Group - Conventional Suture Closure (CSC)

 Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized
 to either #1 DuraMesh™ suture or conventional laparotomy closure using size #1
 slowly-absorbing (PDS) single strand or looped suture, based on surgeon preference. All
 patients will be assessed for post-operative complications at 2 weeks, 1 month, 3 months, 6
 months, and 12 months postoperatively. Patients will also be assessed for incisional hernia
 formation at the same post-operative time points (2 weeks,1 month, 3 months, 6 months, 12
 months). Hernia outcomes will be based on physical examination, with ultrasound used for any
 uncertainties.
Inclusion Criteria:

 -  Midline laparotomy 5 cm (2 inches) long

 -  Urgent or emergent surgery following trauma

 -  Urgent or emergent surgery for diverticulitis

 -  Urgent or emergent surgery for large or small bowel obstruction

 -  Urgent or emergent surgery for exploratory laparotomy for acute abdomen

 -  Urgent or emergent surgery for exploratory laparotomy for intraabdominal hemorrhage

 Exclusion criteria

 -  Inability to provide informed consent

 -  Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias

 -  Metastatic cancer

 -  Pregnancy

 -  Immunosuppression