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

J

Jeffrey Janis

Status

Completed

Conditions

Intestinal Fistula
Fibromatosis, Abdominal
Hernia, Ventral

Treatments

Other: Assess Surgical Site Occurrences at 30 days postoperatively
Procedure: Abdominal wall reconstruction with XenMatrix
Other: Assess physical functioning postoperatively
Other: Assess pain interference postoperatively
Device: XenMatrix
Procedure: Abdominal wall reconstruction with Strattice
Other: Assess hernia recurrence at 1 year postoperatively
Other: Assess overall complications at 30 days postoperatively
Device: Strattice
Other: Assess hernia recurrence at 30 days postoperatively
Other: Assess overall complications at 1 year postoperatively
Other: Assess bulge at 1 year postoperatively
Other: Assess Surgical Site Occurrences at 1 year postoperatively
Other: Assess physical functioning at last office visit preoperatively
Other: Assess bulge at 30 days postoperatively
Other: Assess quality of life postoperatively
Other: Assess patient pain intensity postoperatively
Other: Assess patient quality of life at last office visit preoperatively
Other: Assess pain interference at last office visit preoperatively
Other: Assess pain intensity at last office visit preoperatively

Study type

Interventional

Funder types

Other

Identifiers

NCT02228889
2014H0041

Details and patient eligibility

About

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.

Full 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
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Enrollment

46 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Strattice
Experimental group
Description:
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
Treatment:
Other: Assess pain intensity at last office visit preoperatively
Other: Assess pain interference at last office visit preoperatively
Other: Assess patient quality of life at last office visit preoperatively
Other: Assess patient pain intensity postoperatively
Other: Assess bulge at 30 days postoperatively
Other: Assess quality of life postoperatively
Other: Assess physical functioning at last office visit preoperatively
Other: Assess Surgical Site Occurrences at 1 year postoperatively
Other: Assess bulge at 1 year postoperatively
Other: Assess overall complications at 1 year postoperatively
Other: Assess hernia recurrence at 30 days postoperatively
Device: Strattice
Other: Assess overall complications at 30 days postoperatively
Other: Assess hernia recurrence at 1 year postoperatively
Other: Assess pain interference postoperatively
Procedure: Abdominal wall reconstruction with Strattice
Other: Assess physical functioning postoperatively
Other: Assess Surgical Site Occurrences at 30 days postoperatively
XenMatrix
Experimental group
Description:
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
Treatment:
Other: Assess pain intensity at last office visit preoperatively
Other: Assess pain interference at last office visit preoperatively
Other: Assess patient quality of life at last office visit preoperatively
Other: Assess patient pain intensity postoperatively
Other: Assess bulge at 30 days postoperatively
Other: Assess quality of life postoperatively
Other: Assess physical functioning at last office visit preoperatively
Other: Assess Surgical Site Occurrences at 1 year postoperatively
Other: Assess bulge at 1 year postoperatively
Other: Assess overall complications at 1 year postoperatively
Other: Assess hernia recurrence at 30 days postoperatively
Other: Assess overall complications at 30 days postoperatively
Other: Assess hernia recurrence at 1 year postoperatively
Device: XenMatrix
Other: Assess pain interference postoperatively
Procedure: Abdominal wall reconstruction with XenMatrix
Other: Assess physical functioning postoperatively
Other: Assess Surgical Site Occurrences at 30 days postoperatively
Trial documents
3

Trial contacts and locations

1

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Central trial contact

Benjamin Sarac, MD; Jeffrey E Janis, MD

Data sourced from clinicaltrials.gov

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