Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02451176 |
| Other study ID # |
IRB 14-1571 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2015 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
August 2022 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic
mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of
clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of
this study will have a major impact on the field of hernia surgery as it will provide
objective guide to mesh selection, optimize surgical approaches for complex ventral hernia
repair, and ultimately significantly improve patient outcomes.
Description:
This is a multicenter prospective double-blinded randomized controlled trial comparing 253
patients with clean-contaminated (Class 2)or contaminated (Class3) abdominal wall ventral
hernias undergoing single staged repair. Soft Mesh by CR Bard, a macroporous monofilament
polypropylene permanent mesh will be compared to Strattice mesh by Lifecell, a non-cross
linked porcine dermal biologic graft for the single stage open reconstruction of
clean-contaminated and contaminated abdominal wall defects. The primary outcome variable will
be the absence of surgical site occurence requiring procedural intervention and the absence
of a hernia recurrence from the time of surgery up to 24 months of postoperative follow up.
Patients undergoing open ventral hernia repair for clean-contamination and contaminated
abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic
mesh or a biologic mesh. Randomization will be carried out using computer-generated
randomization blocks at the time of enrollment. Stratified randomized will be used with the
strata formulated by medical center then by clean-contaminated or contaminated surgical site
class. The Investigator will be blinded to patient randomization assignment until the point
of intra-operative device use following final CDC wound classification, whereas patients and
co-investigators responsible for data analysis will remain blinded to patient randomization
until the conclusion of the study period. As such, a double-blinded study protocol will be
maintained. Patients randomized to synthetic mesh will receive SoftMesh™ (CR Bard, Murray
Hill, NJ) and those patients randomized to biologic mesh will receive Strattice™ (Lifecell,
Branchburg NJ). The use of biologic and synthetic mesh in contaminated fields is considered
experimental however the selection of these prosthetics was based on a careful review of the
multiple animal models, preclinical data, and our own clinical experience with each of these
materials placed in both clean and contaminated abdominal wall reconstructions. Surgical
wounds will be classified based on CDC(Centers for Disease Control) criteria and only Class 2
and 3 wounds will be included in this study.
Postoperatively patients will be evaluated for signs and symptoms of complications along with
presence or absence of Surgical Site Infections per CDC guidelines, presence or absence of
surgical site occurrences (SSOs) and any procedural interventions required to treat these
SSOs, presence or absence of hernia recurrence and any reoperations, length of hospital stay,
discharge date, time to return of bowel function and any readmission.
Active participation in this study will last for 24 months and will involve one preoperative
evaluation visit, one operative procedure visit, and 4 follow up visits. Participants will
complete two brief survey questionnaires regarding quality of life, activities and pain.
The second outcome will be to demonstrate that a macroporous light-weight polypropylene mesh
is more cost effective strategy than a biologic prosthetic in clean-contaminated and
contaminated abdominal wall reconstruction
Other known NCT identifiers
