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

43 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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