Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: The COBRA study

Michael J. Rosen, Joel J. Bauer, Marco Harmaty, Alfredo M. Carbonell, William S. Cobb, Brent Matthews, Matthew I. Goldblatt, Don Selzer, Benjamin K. Poulose, Bibi M E Hansson, Camiel Rosman, James J. Chao, Garth R. Jacobsen

Research output: Contribution to journalArticle

56 Citations (Scopus)

Abstract

Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n=104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-totreat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n=24) or removal of infected previously placed mesh (n=29). Hernia recurrence rate was 17% (n=16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P≤0.04). Surgical site infections (19/104) led to higher risk of recurrence (P<0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P<0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Original languageEnglish (US)
Pages (from-to)205-211
Number of pages7
JournalAnnals of Surgery
Volume265
Issue number1
DOIs
StatePublished - 2017

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Ventral Hernia
Surgical Wound Infection
Herniorrhaphy
Longitudinal Studies
Quality of Life
Prospective Studies
Hernia
Recurrence
Kaplan-Meier Estimate
Biocompatible Materials
Centers for Disease Control and Prevention (U.S.)
Infection
Health Surveys
Fistula
Body Mass Index
Outcome Assessment (Health Care)
Health
Wounds and Injuries
Population

Keywords

  • Abdominal wall reconstruction
  • Bioabsorbable mesh
  • Complex ventral hernia repair
  • Contaminated ventral hernia repair

ASJC Scopus subject areas

  • Surgery

Cite this

Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh : The COBRA study. / Rosen, Michael J.; Bauer, Joel J.; Harmaty, Marco; Carbonell, Alfredo M.; Cobb, William S.; Matthews, Brent; Goldblatt, Matthew I.; Selzer, Don; Poulose, Benjamin K.; Hansson, Bibi M E; Rosman, Camiel; Chao, James J.; Jacobsen, Garth R.

In: Annals of Surgery, Vol. 265, No. 1, 2017, p. 205-211.

Research output: Contribution to journalArticle

Rosen, MJ, Bauer, JJ, Harmaty, M, Carbonell, AM, Cobb, WS, Matthews, B, Goldblatt, MI, Selzer, D, Poulose, BK, Hansson, BME, Rosman, C, Chao, JJ & Jacobsen, GR 2017, 'Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: The COBRA study', Annals of Surgery, vol. 265, no. 1, pp. 205-211. https://doi.org/10.1097/SLA.0000000000001601
Rosen, Michael J. ; Bauer, Joel J. ; Harmaty, Marco ; Carbonell, Alfredo M. ; Cobb, William S. ; Matthews, Brent ; Goldblatt, Matthew I. ; Selzer, Don ; Poulose, Benjamin K. ; Hansson, Bibi M E ; Rosman, Camiel ; Chao, James J. ; Jacobsen, Garth R. / Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh : The COBRA study. In: Annals of Surgery. 2017 ; Vol. 265, No. 1. pp. 205-211.
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abstract = "Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n=104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-totreat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77{\%} had contaminated wounds, and 84{\%} completed 24-months follow-up. Concomitant procedures included fistula takedown (n=24) or removal of infected previously placed mesh (n=29). Hernia recurrence rate was 17{\%} (n=16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P≤0.04). Surgical site infections (19/104) led to higher risk of recurrence (P<0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P<0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.",
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T1 - Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh

T2 - The COBRA study

AU - Rosen, Michael J.

AU - Bauer, Joel J.

AU - Harmaty, Marco

AU - Carbonell, Alfredo M.

AU - Cobb, William S.

AU - Matthews, Brent

AU - Goldblatt, Matthew I.

AU - Selzer, Don

AU - Poulose, Benjamin K.

AU - Hansson, Bibi M E

AU - Rosman, Camiel

AU - Chao, James J.

AU - Jacobsen, Garth R.

PY - 2017

Y1 - 2017

N2 - Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n=104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-totreat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n=24) or removal of infected previously placed mesh (n=29). Hernia recurrence rate was 17% (n=16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P≤0.04). Surgical site infections (19/104) led to higher risk of recurrence (P<0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P<0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

AB - Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm2 had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n=104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-totreat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n=24) or removal of infected previously placed mesh (n=29). Hernia recurrence rate was 17% (n=16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P≤0.04). Surgical site infections (19/104) led to higher risk of recurrence (P<0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P<0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

KW - Abdominal wall reconstruction

KW - Bioabsorbable mesh

KW - Complex ventral hernia repair

KW - Contaminated ventral hernia repair

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