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

Hernia, Ventral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228889
• Other study ID #: 2014H0041
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Ohio State University
• Contact: Benjamin Sarac, MD
• Phone: (614) 293-8566
• Email: Benjamin.Sarac[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibroma
• Fibromatosis, Abdominal
• Fistula
• Hernia
• Hernia, Ventral
• Intestinal Fistula

Intervention

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)
• Assess pain interference at last office visit preoperatively
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
• Assess physical functioning at last office visit preoperatively
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
• 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)
• Assess patient pain intensity postoperatively
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
• Assess pain interference postoperatively
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
• Assess physical functioning postoperatively
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
• Assess quality of life postoperatively
Assess quality of life at 1 year postoperatively using the HerQLes survey
• Assess hernia recurrence at 30 days postoperatively
Assess hernia recurrence at 30 days
• Assess bulge at 30 days postoperatively
Assess bulge at 30 days
• Assess Surgical Site Occurrences at 30 days postoperatively
Assess Surgical Site Occurrences at 30 days
• Assess hernia recurrence at 1 year postoperatively
Assess hernia recurrence at 1 year postoperatively
• Assess bulge at 1 year postoperatively
Assess bulge at 1 year postoperatively
• Assess Surgical Site Occurrences 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 XenMatrix
Abdominal wall reconstruction with XenMatrix

Device:
• Strattice
Strattice mesh
• XenMatrix
Xenmatrix mesh

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Janis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hernia recurrence rate at 30 days		30 days postoperatively
Secondary	Bulge rate at 30 days		30 days postoperatively
Secondary	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
Secondary	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
Secondary	Hernia recurrence rate at 1 year		1 year postoperatively
Secondary	Bulge rate at 1 year		1 year postoperatively
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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