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

NCT02228889 | Completed Results

• 1 other identifier: 2014H0041
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Ventral; Intestinal Fistula; Fibromatosis, Abdominal

Keywords

Hernia; Abdominal wall reconstruction; Abdominal wall defect; Porcine mesh; Component separation; Abdominal wall tumor; Desmoid

Outcome Measures

Primary Outcomes (1)

• Rate of Surgical Site Occurrences (SSOs) at 6 Week

  Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection

  6 week postoperatively

Study Arms (2)

Strattice

EXPERIMENTAL

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; 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

XenMatrix

EXPERIMENTAL

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; 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; Procedure: Abdominal wall reconstruction with XenMatrix; Device: XenMatrix

Interventions

Abdominal wall reconstruction with Strattice PROCEDURE

Abdominal wall reconstruction using Strattice

Strattice

Assess pain intensity at last office visit preoperatively OTHER

Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)

Strattice; XenMatrix

Assess pain interference at last office visit preoperatively OTHER

Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)

Strattice; XenMatrix

Assess physical functioning at last office visit preoperatively OTHER

Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)

Strattice; XenMatrix

Assess patient quality of life at last office visit preoperatively OTHER

Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)

Strattice; XenMatrix

Assess patient pain intensity postoperatively OTHER

Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey

Strattice; XenMatrix

Assess pain interference postoperatively OTHER

Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey

Strattice; XenMatrix

Assess physical functioning postoperatively OTHER

Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey

Strattice; XenMatrix

Assess quality of life postoperatively OTHER

Assess quality of life at 1 year postoperatively using the HerQLes survey

Strattice; XenMatrix

Assess hernia recurrence at 30 days postoperatively OTHER

Assess hernia recurrence at 30 days

Strattice; XenMatrix

Assess bulge at 30 days postoperatively OTHER

Assess bulge at 30 days

Strattice; XenMatrix

Assess Surgical Site Occurrences at 30 days postoperatively OTHER

Assess Surgical Site Occurrences at 30 days

Strattice; XenMatrix

Assess hernia recurrence at 1 year postoperatively OTHER

Assess hernia recurrence at 1 year postoperatively

Strattice; XenMatrix

Assess bulge at 1 year postoperatively OTHER

Assess bulge at 1 year postoperatively

Strattice; XenMatrix

Assess Surgical Site Occurrences at 1 year postoperatively OTHER

Assess Surgical Site Occurrences at 1 year postoperatively

Strattice; XenMatrix

Assess overall complications at 30 days postoperatively OTHER

Strattice; XenMatrix

Assess overall complications at 1 year postoperatively OTHER

Strattice; XenMatrix

Abdominal wall reconstruction with XenMatrix PROCEDURE

Abdominal wall reconstruction with XenMatrix

XenMatrix

Strattice DEVICE

Strattice mesh

Strattice

XenMatrix DEVICE

Xenmatrix mesh

XenMatrix

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeffrey Janis: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Intestinal Fistula; Fibromatosis, Abdominal; Hernia; Peritoneal Neoplasms; Desmoid Tumors

Interventions

Abdominoplasty; strattice

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Fistula; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Limitations and Caveats

The study was completed prior to the anticipated 70 total participants, as new data and literature have shifted a national trend away from the use of biologic mesh and toward synthetic mesh, which significantly impeded recruitment.

Results Point of Contact

• Title: Dr. Jeffrey Janis
• Organization: The Ohio State University Wexner Medical Center

jeffrey.janis@osumc.edu

(614) 297-2913

Study Officials

• Jeffrey E Janis, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Plastic Surgery, Vice-Chairman

Model Details: Abdominal wall reconstruction using Strattice

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 29, 2014
• Study Start: January 1, 2015
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Locations

US (1)