Open Midline Laparotomy
Conditions
Brief summary
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.
Detailed description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Interventions
DEVICEPhasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be ≥ 18 years of age 2. Elective, open midline laparotomy ≥ 5 cm 3. Willing and able to provide written informed consent 4. Hernia risk equal to moderate or greater
Exclusion criteria
1. Previous hernia repair 2. Emergent surgery 3. Creation of skin flaps is preplanned 4. Preplanned 2nd surgery 5. Active skin pathology 6. Life expectancy less than 24 months 7. Pregnant or planning to become pregnant 8. Receiving a medication/medical condition that may adversely affect wound healing 9. ASA Class \> IV 10. Enrolled in another clinical trial 11. Site personnel directly involved with this trial 12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements 13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate 14. Two separate incisions are created 15. Prior onlay mesh 16. Surgeon is unable to fully close the fascia 17. The surgery requires more than a single piece of mesh 18. Contraindication to placement of mesh 19. CDC Class IV/Active Infection 20. Breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Incisional Hernia | 24-Months | The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Incisional Hernia | 60-Months | Rate of incisional hernia at each follow up time point |
| Rate of Device-related Adverse Events (AEs) | 60-Months | Rate of Device-related Adverse Events (AEs) |
| Length of surgical procedure in minutes | Study Day 0 | Length of surgical procedure in minutes |
| Length of time for wound closure in minutes | Study Day 0 | Length of time for wound closure in minutes |
| Length of hospital stay in days | Through hospital stay, typically 3 days | Length of hospital stay in days |
| Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) | 60-Months | Health-related quality of life will be measured using the Optum SF-12v2. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores from the subject's perspective (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better quality of life. |
| Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) | 60-months | EuroQoL-Five Dimensions questionnaire-using Three Levels EQ-5D-3L is a standardized instrument for measuring generic health status. It consists of two components; health status description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves visual analogue scale, asking the subject to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine". |
Countries
Austria, Belgium, France, Germany, United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Hope, MD
New Hanover Regional Medical Center
Outcome results
None listed