Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT): Prospective, Multi Center, Open Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
D
Dimitrios Stefanidis, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
3 Locations
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
- Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Open Midline Laparotomy
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 36 months
- Pregnant or planning to become pregnant
- Receiving a medication/medical condition that may adversely affect wound healing
- ASA Class > IV
- Enrolled in another clinical trial
- Site personnel directly involved with this trial
- Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions are created
- Prior onlay mesh
- Surgeon is unable to fully close the fascia
- The surgery requires more than a single piece of mesh
- Contraindication to placement of mesh
- CDC Class IV/Active Infection
Updated on
01 Aug 2024.
Study ID: 2002367601, TX11405, SURG-DAVOL-PREVENT
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