Dataset Information

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.

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?cm 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-to-treat 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/m, 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.

SUBMITTER: Rosen MJ

PROVIDER: S-EPMC5181129 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 MJ Bauer Joel J JJ Harmaty Marco M Carbonell Alfredo M AM Cobb William S WS Matthews Brent B Goldblatt Matthew I MI Selzer Don J DJ Poulose Benjamin K BK Hansson Bibi M E BM Rosman Camiel C Chao James J JJ Jacobsen Garth R GR

Annals of surgery 20170101 1

<h4>Objective</h4>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.<h4>Background</h4>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.<h4>Methods</h4>Patients with a contaminated or clean-contaminated operative field and a hernia defec ...[more]

PMID: 28009747

Similar Datasets

Project description:BackgroundThe objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair.MethodsBilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point).ResultsPrior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal-mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal-mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling.ConclusionsPhasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.

Project description:PurposeThe use of mesh is a common practice in ventral hernia repair (VHR). Lack of consensus on which prosthetic material works better in different settings remains. This meta-analysis aims to summarize the available evidence on hernia recurrence and complications after repair with synthetic, biologic, or biosynthetic/bioabsorbable meshes in hernias grade 2-3 of the Ventral Hernia Working Group modified classification.MethodsA literature search was conducted in January 2021 using Web of Science (WoS), Scopus, and MEDLINE (via PubMed) databases. Randomized Controlled Trials (RCTs) and observational studies with adult patients undergoing VHR with either synthetic, biologic, or biosynthetic/bioabsorbable mesh were included. Outcomes were hernia recurrence, Surgical Site Occurrence (SSO), Surgical Site Infection (SSI), 30 days re-intervention, and infected mesh removal. Random-effects meta-analyses of pooled proportions were performed. Quality of the studies was assessed, and heterogeneity was explored through sensitivity analyses.Results25 articles were eligible for inclusion. Mean age ranged from 47 to 64 years and participants' follow-up ranged from 1 to 36 months. Biosynthetic/bioabsorbable mesh reported a 9% (95% CI 2-19%) rate of hernia recurrence, lower than synthetic and biologic meshes. Biosynthetic/bioabsorbable mesh repair also showed a lower incidence of SSI, with a 14% (95% CI 6-24%) rate, and there was no evidence of infected mesh removal. Rates of seroma were similar for the different materials.ConclusionsThis meta-analysis did not show meaningful differences among materials. However, the best proportions towards lower recurrence and complication rates after grade 2-3 VHR were after using biosynthetic/slowly absorbable mesh reinforcement. These results should be taken with caution, as head-to-head comparative studies between biosynthetic and synthetic/biologic meshes are lacking. Although, biosynthetic/bioabsorbable materials could be considered an alternative to synthetic and biologic mesh reinforcement in these settings.

Project description:BackgroundIn ventral hernia surgery, mesh implants are used to reduce recurrence. Infection after mesh implantation can be a problem and rates around 6-10% have been reported. Bacterial colonization of mesh implants in patients without clinical signs of infection has not been thoroughly investigated. Molecular techniques have proven effective in demonstrating bacterial diversity in various environments and are able to identify bacteria on a gene-specific level.ObjectiveThe purpose of this study was to detect bacterial biofilm in mesh implants, analyze its bacterial diversity, and look for possible resemblance with bacterial biofilm from the periodontal pocket.MethodsThirty patients referred to our hospital for recurrence after former ventral hernia mesh repair, were examined for periodontitis in advance of new surgical hernia repair. Oral examination included periapical radiographs, periodontal probing, and subgingival plaque collection. A piece of mesh (1×1 cm) from the abdominal wall was harvested during the new surgical hernia repair and analyzed for bacteria by PCR and 16S rRNA gene sequencing. From patients with positive PCR mesh samples, subgingival plaque samples were analyzed with the same techniques.ResultsA great variety of taxa were detected in 20 (66.7%) mesh samples, including typical oral commensals and periodontopathogens, enterics, and skin bacteria. Mesh and periodontal bacteria were further analyzed for similarity in 16S rRNA gene sequences. In 17 sequences, the level of resemblance between mesh and subgingival bacterial colonization was 98-100% suggesting, but not proving, a transfer of oral bacteria to the mesh.ConclusionThe results show great bacterial diversity on mesh implants from the anterior abdominal wall including oral commensals and periodontopathogens. Mesh can be reached by bacteria in several ways including hematogenous spread from an oral site. However, other sites such as gut and skin may also serve as sources for the mesh biofilm.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets