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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Phasix™ Mesh
DevicePhasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Treatment groups
477 Participants
are divided into 2 treatment groupsGroup A: Phasix™ MeshExperimental treatment 1 intervention
Group B: Primary Suture ClosureNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of Incisional Hernia
The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
Time frame
24-MonthsSecondary outcomes
1
Rate of Incisional Hernia
Rate of incisional hernia at each follow up time point
Time frame
60-Months2
Rate of Device-related Adverse Events (AEs)
Rate of Device-related Adverse Events (AEs)
Time frame
60-Months3
Length of surgical procedure in minutes
Length of surgical procedure in minutes
Time frame
Study Day 04
Length of time for wound closure in minutes
Length of time for wound closure in minutes
Time frame
Study Day 0 Source ClinicalTrials.gov