Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: The RICH Study

Background In the presence of contamination, the repair of a ventral incisional hernia (VIH) is challenging. The presence of comorbidities poses an additional risk for postoperative wound events and hernia recurrence. To date, very few studies describe the outcomes of VIH repair in this high-risk po...

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Veröffentlicht in:Surgery 2012-09, Vol.152 (3), p.498-505
Hauptverfasser: Itani, Kamal M.F., MD, FACS, Rosen, Michael, MD, FACS, Vargo, Daniel, MD, FACS, Awad, Samir S., MD, FACS, DeNoto, George, MD, FACS, Butler, Charles E., MD, FACS
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container_end_page 505
container_issue 3
container_start_page 498
container_title Surgery
container_volume 152
creator Itani, Kamal M.F., MD, FACS
Rosen, Michael, MD, FACS
Vargo, Daniel, MD, FACS
Awad, Samir S., MD, FACS
DeNoto, George, MD, FACS
Butler, Charles E., MD, FACS
description Background In the presence of contamination, the repair of a ventral incisional hernia (VIH) is challenging. The presence of comorbidities poses an additional risk for postoperative wound events and hernia recurrence. To date, very few studies describe the outcomes of VIH repair in this high-risk population. Methods A prospective, multicenter, single-arm, the Repair of Infected or Contaminated Hernias study was performed to study the clinical outcomes of open VIH repair of contaminated abdominal defects with a non–cross-linked, porcine, acellular dermal matrix, Strattice. Results Of 85 patients who consented to participate, 80 underwent open VIH repair with Strattice. Hernia defects were ‘clean-contaminated’ ( n = 39), ‘contaminated’ ( n = 39), or ‘dirty’ ( n = 2), and the defects were classified as grade 3 ( n = 60) or grade 4 ( n = 20). The midline was restored, and primary closure was achieved in 64 patients; the defect was bridged in 16 patients. At 24 months, 53 patients (66%) experienced 95 wound events. There were 28 unique, infection-related events in 24 patients. Twenty-two patients experienced seromas, all but 5 of which were transient and required no intervention. No unanticipated adverse events occurred, and no tissue matrix required complete excision. There were 22 hernia (28%) recurrences by month 24. There was no correlation between infection-related events and hernia recurrence. Conclusion The use of the intact, non–cross-linked, porcine, acellular dermal matrix, Strattice, in the repair of contaminated VIH in high-risk patients allowed for successful, single-stage reconstruction in >70% of patients followed for 24 months after repair.
doi_str_mv 10.1016/j.surg.2012.04.008
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The presence of comorbidities poses an additional risk for postoperative wound events and hernia recurrence. To date, very few studies describe the outcomes of VIH repair in this high-risk population. Methods A prospective, multicenter, single-arm, the Repair of Infected or Contaminated Hernias study was performed to study the clinical outcomes of open VIH repair of contaminated abdominal defects with a non–cross-linked, porcine, acellular dermal matrix, Strattice. Results Of 85 patients who consented to participate, 80 underwent open VIH repair with Strattice. Hernia defects were ‘clean-contaminated’ ( n = 39), ‘contaminated’ ( n = 39), or ‘dirty’ ( n = 2), and the defects were classified as grade 3 ( n = 60) or grade 4 ( n = 20). The midline was restored, and primary closure was achieved in 64 patients; the defect was bridged in 16 patients. At 24 months, 53 patients (66%) experienced 95 wound events. There were 28 unique, infection-related events in 24 patients. Twenty-two patients experienced seromas, all but 5 of which were transient and required no intervention. No unanticipated adverse events occurred, and no tissue matrix required complete excision. There were 22 hernia (28%) recurrences by month 24. There was no correlation between infection-related events and hernia recurrence. Conclusion The use of the intact, non–cross-linked, porcine, acellular dermal matrix, Strattice, in the repair of contaminated VIH in high-risk patients allowed for successful, single-stage reconstruction in &gt;70% of patients followed for 24 months after repair.</description><identifier>ISSN: 0039-6060</identifier><identifier>EISSN: 1532-7361</identifier><identifier>DOI: 10.1016/j.surg.2012.04.008</identifier><identifier>PMID: 22763262</identifier><identifier>CODEN: SURGAZ</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Activities of Daily Living ; Animals ; Biological and medical sciences ; Bioprosthesis ; Collagen - therapeutic use ; Disease Models, Animal ; Female ; Follow-Up Studies ; General aspects ; Hernia, Abdominal - complications ; Hernia, Abdominal - mortality ; Hernia, Abdominal - therapy ; Herniorrhaphy - adverse effects ; Herniorrhaphy - methods ; Herniorrhaphy - mortality ; Humans ; Infection - complications ; Length of Stay ; Male ; Medical sciences ; Middle Aged ; Prospective Studies ; Recurrence ; Seroma - etiology ; Seroma - therapy ; Surgery ; Surgical Wound Infection - etiology ; Surgical Wound Infection - mortality ; Surgical Wound Infection - therapy ; Swine ; Treatment Outcome</subject><ispartof>Surgery, 2012-09, Vol.152 (3), p.498-505</ispartof><rights>2012</rights><rights>2015 INIST-CNRS</rights><rights>Published by Mosby, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c441t-c4db3082ffc9a70db989433be078111a5cc26f577e1b598c93083a79b6734d9d3</citedby><cites>FETCH-LOGICAL-c441t-c4db3082ffc9a70db989433be078111a5cc26f577e1b598c93083a79b6734d9d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0039606012002012$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=26354779$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22763262$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Itani, Kamal M.F., MD, FACS</creatorcontrib><creatorcontrib>Rosen, Michael, MD, FACS</creatorcontrib><creatorcontrib>Vargo, Daniel, MD, FACS</creatorcontrib><creatorcontrib>Awad, Samir S., MD, FACS</creatorcontrib><creatorcontrib>DeNoto, George, MD, FACS</creatorcontrib><creatorcontrib>Butler, Charles E., MD, FACS</creatorcontrib><creatorcontrib>RICH Study Group</creatorcontrib><title>Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: The RICH Study</title><title>Surgery</title><addtitle>Surgery</addtitle><description>Background In the presence of contamination, the repair of a ventral incisional hernia (VIH) is challenging. The presence of comorbidities poses an additional risk for postoperative wound events and hernia recurrence. To date, very few studies describe the outcomes of VIH repair in this high-risk population. Methods A prospective, multicenter, single-arm, the Repair of Infected or Contaminated Hernias study was performed to study the clinical outcomes of open VIH repair of contaminated abdominal defects with a non–cross-linked, porcine, acellular dermal matrix, Strattice. Results Of 85 patients who consented to participate, 80 underwent open VIH repair with Strattice. Hernia defects were ‘clean-contaminated’ ( n = 39), ‘contaminated’ ( n = 39), or ‘dirty’ ( n = 2), and the defects were classified as grade 3 ( n = 60) or grade 4 ( n = 20). The midline was restored, and primary closure was achieved in 64 patients; the defect was bridged in 16 patients. At 24 months, 53 patients (66%) experienced 95 wound events. There were 28 unique, infection-related events in 24 patients. Twenty-two patients experienced seromas, all but 5 of which were transient and required no intervention. No unanticipated adverse events occurred, and no tissue matrix required complete excision. There were 22 hernia (28%) recurrences by month 24. There was no correlation between infection-related events and hernia recurrence. 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Rosen, Michael, MD, FACS ; Vargo, Daniel, MD, FACS ; Awad, Samir S., MD, FACS ; DeNoto, George, MD, FACS ; Butler, Charles E., MD, FACS</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c441t-c4db3082ffc9a70db989433be078111a5cc26f577e1b598c93083a79b6734d9d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Activities of Daily Living</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Bioprosthesis</topic><topic>Collagen - therapeutic use</topic><topic>Disease Models, Animal</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>General aspects</topic><topic>Hernia, Abdominal - complications</topic><topic>Hernia, Abdominal - mortality</topic><topic>Hernia, Abdominal - therapy</topic><topic>Herniorrhaphy - adverse effects</topic><topic>Herniorrhaphy - methods</topic><topic>Herniorrhaphy - mortality</topic><topic>Humans</topic><topic>Infection - complications</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Seroma - etiology</topic><topic>Seroma - therapy</topic><topic>Surgery</topic><topic>Surgical Wound Infection - etiology</topic><topic>Surgical Wound Infection - mortality</topic><topic>Surgical Wound Infection - therapy</topic><topic>Swine</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Itani, Kamal M.F., MD, FACS</creatorcontrib><creatorcontrib>Rosen, Michael, MD, FACS</creatorcontrib><creatorcontrib>Vargo, Daniel, MD, FACS</creatorcontrib><creatorcontrib>Awad, Samir S., MD, FACS</creatorcontrib><creatorcontrib>DeNoto, George, MD, FACS</creatorcontrib><creatorcontrib>Butler, Charles E., MD, FACS</creatorcontrib><creatorcontrib>RICH Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Itani, Kamal M.F., MD, FACS</au><au>Rosen, Michael, MD, FACS</au><au>Vargo, Daniel, MD, FACS</au><au>Awad, Samir S., MD, FACS</au><au>DeNoto, George, MD, FACS</au><au>Butler, Charles E., MD, FACS</au><aucorp>RICH Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: The RICH Study</atitle><jtitle>Surgery</jtitle><addtitle>Surgery</addtitle><date>2012-09-01</date><risdate>2012</risdate><volume>152</volume><issue>3</issue><spage>498</spage><epage>505</epage><pages>498-505</pages><issn>0039-6060</issn><eissn>1532-7361</eissn><coden>SURGAZ</coden><abstract>Background In the presence of contamination, the repair of a ventral incisional hernia (VIH) is challenging. The presence of comorbidities poses an additional risk for postoperative wound events and hernia recurrence. To date, very few studies describe the outcomes of VIH repair in this high-risk population. Methods A prospective, multicenter, single-arm, the Repair of Infected or Contaminated Hernias study was performed to study the clinical outcomes of open VIH repair of contaminated abdominal defects with a non–cross-linked, porcine, acellular dermal matrix, Strattice. Results Of 85 patients who consented to participate, 80 underwent open VIH repair with Strattice. Hernia defects were ‘clean-contaminated’ ( n = 39), ‘contaminated’ ( n = 39), or ‘dirty’ ( n = 2), and the defects were classified as grade 3 ( n = 60) or grade 4 ( n = 20). The midline was restored, and primary closure was achieved in 64 patients; the defect was bridged in 16 patients. At 24 months, 53 patients (66%) experienced 95 wound events. There were 28 unique, infection-related events in 24 patients. Twenty-two patients experienced seromas, all but 5 of which were transient and required no intervention. No unanticipated adverse events occurred, and no tissue matrix required complete excision. There were 22 hernia (28%) recurrences by month 24. There was no correlation between infection-related events and hernia recurrence. Conclusion The use of the intact, non–cross-linked, porcine, acellular dermal matrix, Strattice, in the repair of contaminated VIH in high-risk patients allowed for successful, single-stage reconstruction in &gt;70% of patients followed for 24 months after repair.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>22763262</pmid><doi>10.1016/j.surg.2012.04.008</doi><tpages>8</tpages></addata></record>
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subjects Activities of Daily Living
Animals
Biological and medical sciences
Bioprosthesis
Collagen - therapeutic use
Disease Models, Animal
Female
Follow-Up Studies
General aspects
Hernia, Abdominal - complications
Hernia, Abdominal - mortality
Hernia, Abdominal - therapy
Herniorrhaphy - adverse effects
Herniorrhaphy - methods
Herniorrhaphy - mortality
Humans
Infection - complications
Length of Stay
Male
Medical sciences
Middle Aged
Prospective Studies
Recurrence
Seroma - etiology
Seroma - therapy
Surgery
Surgical Wound Infection - etiology
Surgical Wound Infection - mortality
Surgical Wound Infection - therapy
Swine
Treatment Outcome
title Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: The RICH Study
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