Clinical trial NCT02228889: RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Official title: Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Ventral
Intestinal Fistula
Fibromatosis, Abdominal
Keywords: Hernia
Abdominal wall reconstruction
Abdominal wall defect
Porcine mesh
Component separation
Abdominal wall tumor
Desmoid
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Abdominal wall reconstruction using Strattice
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

Detailed description: This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).

Our goals in this study are:

1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
2. SECONDARY OUTCOMES

i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
* Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
* Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).

Exclusion Criteria:

* Known allergy to porcine products
* Active smokers (within the past 4 weeks) presenting for elective hernia repair
* Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
* Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
* Patients with severe systemic sepsis
* Patients with frank purulence in the wound

Primary outcomes:
measure: Rate of Surgical Site Occurrences (SSOs) at 6 Week
timeFrame: 6 week postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey E Janis, MD
role: PRINCIPAL_INVESTIGATOR
References: