Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
ConditionOpen Midline Laparotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorC. R. Bard
About this trial
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Eligibility criteria
Qualifiers
Must be ≥ 18 years of age
Elective, open midline laparotomy ≥ 5 cm
Willing and able to provide written informed consent
Hernia risk equal to moderate or greater
Disqualifiers
Previous hernia repair
Emergent surgery
Creation of skin flaps is preplanned
Preplanned 2nd surgery
Trial design
Treatments tested in this trial
- Phasix™ Mesh
Treatment groups
477 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov