Prospective, multicenter study of antimicrobial-coated, noncrosslinked, acellular porcine dermal matrix (XenMatrix™ AB Surgical Graft) for hernia repair in all centers for disease control and prevention wound classes: 24-month follow-up cohort

Author:

IIahi Obeid N.1ORCID,Velmahos George2,Janis Jeffrey E.3ORCID,Kovach Stephen J.4,McLean Susan F.5ORCID,Askari Reza6,Sommer Courtney A.7,Agarwal Suresh7,Srinivasan Jahnavi8ORCID,Wong Alex K.9ORCID,Pakula Andrea10,Miranda Edward P.11,Breen Kerry2ORCID,Shapiro Mark7,Deeken Corey R.12ORCID,Stringer R. Cody12,McGraw J. Reed4ORCID,Bascone Corey4ORCID,Martindale Robert G.13ORCID

Affiliation:

1. Washington University School of Medicine

2. Massachusetts General Hospital

3. The Ohio State University, Columbus, OH

4. University of Pennsylvania, Philadelphia, PA

5. Texas Tech University Health Science Center School of Medicine, El Paso, TX

6. Brigham and Women’s Hospital, Boston, MA

7. Duke University Medical Center, Durham, NC

8. Emory University, Atlanta, GA

9. City of Hope National Medical Center, Duarte, CA

10. Kern Medical, Bakersfield

11. University of California San Francisco, San Francisco, CA

12. Covalent Bio, LLC, St. Louis, MO

13. Oregon Health & Science University, Portland, OR

Abstract

Background: Prospective, multicenter, single-arm study of antimicrobial-coated, noncrosslinked, acellular porcine dermal matrix (AC-PDM) in a cohort involving all centers for disease control and prevention wound classes in ventral/incisional midline hernia repair (VIHR). Materials and methods: Seventy-five patients (mean age 58.6±12.7 years; BMI 31.3±4.9 kg/m2) underwent ventral/incisional midline hernia repair with AC-PDM. Surgical site occurrence (SSO) was assessed in the first 45 days post-implantation. Length of stay, return to work, hernia recurrence, reoperation, quality of life, and SSO were assessed at 1, 3, 6, 12, 18, and 24 months. Results: 14.7% of patients experienced SSO requiring intervention within 45 days post-implantation, and 20.0% thereafter (>45 d post-implantation). Recurrence (5.8%), definitely device-related adverse events (4.0%), and reoperation (10.7%) were low at 24 months; all quality-of-life indicators were significantly improved compared to baseline. Conclusion: AC-PDM exhibited favourable results, including infrequent hernia recurrence and definitely device-related adverse events, with reoperation and SSO comparable to other studies, and significantly improved quality of life.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Reference21 articles.

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