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

Last updated: May 20, 2025
Sponsor: Jeffrey Janis
Overall Status: Completed

Phase

N/A

Condition

Ileus

Hernia

Treatment

Abdominal wall reconstruction with XenMatrix

Assess overall complications at 1 year postoperatively

Assess patient quality of life at last office visit preoperatively

Clinical Study ID

NCT02228889
2014H0041
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 herniasize, discomfort, risk of bowel incarceration, effect on physical function), and whohave comorbidities or contamination making the use of synthetic meshcontraindicated)

  • Patients deemed to be good surgical candidates, with no active life-threateningcardiac disease, pulmonary disease, renal disease, hematologic disease (patients whocan have a major surgical procedure without an exceedingly high risk of medicalcomplications 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 toundergo 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 intheir fascia after resection, who need biologic mesh for reinforcement).

Exclusion

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, renaldisease, hematologic disease presenting for elective hernia repair

  • Patients presenting for emergent hernia repair (in the setting of bowelstrangulation, necrosis, penetrating trauma) as it will be difficult to consentthose patients for the study preoperatively

  • Patients with severe systemic sepsis

  • Patients with frank purulence in the wound

Study Design

Total Participants: 46
Treatment Group(s): 20
Primary Treatment: Abdominal wall reconstruction with XenMatrix
Phase:
Study Start date:
January 01, 2015
Estimated Completion Date:
March 27, 2025

Study 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

Connect with a study center

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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