RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Fistula; Hernia, Ventral; Fibromatosis, Abdominal
• Intervention / Treatment: Procedure: Abdominal wall reconstruction with Strattice; Other: Assess pain intensity at last office visit preoperatively; Other: Assess pain interference at last office visit preoperatively; Other: Assess physical functioning at last office visit preoperatively; Other: Assess patient quality of life at last office visit preoperatively; Other: Assess patient pain intensity postoperatively; Other: Assess pain interference postoperatively; Other: Assess physical functioning postoperatively; Other: Assess quality of life postoperatively; Other: Assess hernia recurrence at 30 days postoperatively; Other: Assess bulge at 30 days postoperatively; Other: Assess Surgical Site Occurrences at 30 days postoperatively; Other: Assess hernia recurrence at 1 year postoperatively; Other: Assess bulge at 1 year postoperatively; Other: Assess Surgical Site Occurrences at 1 year postoperatively; Other: Assess overall complications at 30 days postoperatively; Other: Assess overall complications at 1 year postoperatively; Device: Strattice; Procedure: Abdominal wall reconstruction with XenMatrix; Device: XenMatrix

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey E Janis, MD; Phone Number: 614-366-1704; Email: jeffrey.janis@osumc.edu
• Study Contact Backup: Name: Benjamin Sarac, MD; Phone Number: (614) 293-8566; Email: Benjamin.Sarac@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Sub-Investigator: Benjamin Sarac, MD
      • Principal Investigator: Jeffrey E Janis, MD
      • Sub-Investigator: Daniel S Eiferman, MD
      • Sub-Investigator: Vimal Narula, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strattice; Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively	Procedure: Abdominal wall reconstruction with Strattice; Abdominal wall reconstruction using Strattice; Other: Assess pain intensity at last office visit preoperatively; Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively); Other: Assess pain interference at last office visit preoperatively; Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively); Other: Assess physical functioning at last office visit preoperatively; Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively); Other: Assess patient quality of life at last office visit preoperatively; Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively); Other: Assess patient pain intensity postoperatively; Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey; Other: Assess pain interference postoperatively; Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey; Other: Assess physical functioning postoperatively; Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey; Other: Assess quality of life postoperatively; Assess quality of life at 1 year postoperatively using the HerQLes survey; Other: Assess hernia recurrence at 30 days postoperatively; Assess hernia recurrence at 30 days; Other: Assess bulge at 30 days postoperatively; Assess bulge at 30 days; Other: Assess Surgical Site Occurrences at 30 days postoperatively; Assess Surgical Site Occurrences at 30 days; Other: Assess hernia recurrence at 1 year postoperatively; Assess hernia recurrence at 1 year postoperatively; Other: Assess bulge at 1 year postoperatively; Assess bulge at 1 year postoperatively; Other: Assess Surgical Site Occurrences at 1 year postoperatively; Assess Surgical Site Occurrences at 1 year postoperatively; Other: Assess overall complications at 30 days postoperatively; Other: Assess overall complications at 1 year postoperatively; Device: Strattice; Strattice mesh
Experimental: XenMatrix; Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively	Other: Assess pain intensity at last office visit preoperatively; Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively); Other: Assess pain interference at last office visit preoperatively; Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively); Other: Assess physical functioning at last office visit preoperatively; Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively); Other: Assess patient quality of life at last office visit preoperatively; Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively); Other: Assess patient pain intensity postoperatively; Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey; Other: Assess pain interference postoperatively; Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey; Other: Assess physical functioning postoperatively; Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey; Other: Assess quality of life postoperatively; Assess quality of life at 1 year postoperatively using the HerQLes survey; Other: Assess hernia recurrence at 30 days postoperatively; Assess hernia recurrence at 30 days; Other: Assess bulge at 30 days postoperatively; Assess bulge at 30 days; Other: Assess Surgical Site Occurrences at 30 days postoperatively; Assess Surgical Site Occurrences at 30 days; Other: Assess hernia recurrence at 1 year postoperatively; Assess hernia recurrence at 1 year postoperatively; Other: Assess bulge at 1 year postoperatively; Assess bulge at 1 year postoperatively; Other: Assess Surgical Site Occurrences at 1 year postoperatively; Assess Surgical Site Occurrences at 1 year postoperatively; Other: Assess overall complications at 30 days postoperatively; Other: Assess overall complications at 1 year postoperatively; Procedure: Abdominal wall reconstruction with XenMatrix; Abdominal wall reconstruction with XenMatrix; Device: XenMatrix; Xenmatrix mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall complication rate at 1 year	Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively	1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Surgical Site Occurrences (SSOs) at 1 year	Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: Infection; Seroma; Hematoma; Wound dehiscence; Skin necrosis; Formation of enterocutaneous fistula; Mesh infection	1 year postoperatively
Hernia recurrence rate at 30 days		30 days postoperatively
Bulge rate at 30 days		30 days postoperatively
Overall complication rate at 30 days	Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively	30 days postoperatively
Rate of Surgical Site Occurrences (SSOs) at 30 days	Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include: Infection; Seroma; Hematoma; Wound dehiscence; Skin necrosis; Formation of enterocutaneous fistula; Mesh infection	30 days postoperatively
Hernia recurrence rate at 1 year		1 year postoperatively
Bulge rate at 1 year		1 year postoperatively
Pain intensity preoperatively	Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey	At the last office visit before surgery (average of 1-3 weeks before surgery)
Pain interference preoperatively	Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey	At the last office visit before surgery (average of 1-3 weeks before surgery)
Pain intensity postoperatively	Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey	1 year postoperatively
Pain interference postoperatively	Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey	1 year postoperatively
Physical functioning preoperatively	Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey	At the last office visit before surgery (average of 1-3 weeks before surgery)
Physical functioning postoperatively	Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey	1 year postoperatively
Quality of life preoperatively	Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)	At the last office visit before surgery (average of 1-3 weeks before surgery)
Quality of life postoperatively	Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)	1 year postoperatively

Collaborators and Investigators

• Sponsor: Jeffrey Janis
• Investigators: Principal Investigator: Jeffrey E Janis, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimated): August 29, 2014

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hernia; Abdominal wall reconstruction; Desmoid; Abdominal wall defect; Porcine mesh; Component separation; Abdominal wall tumor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Neoplasms, Connective Tissue; Digestive System Fistula; Neoplasms, Fibrous Tissue; Hernia; Fistula; Hernia, Ventral; Fibroma; Intestinal Fistula; Fibromatosis, Abdominal
• Other Study ID Numbers: 2014H0041