Poly-4-hydroxybutyrate (Phasix™) mesh onlay in complex abdominal wall repair

Levy, Adam; Bernstein, Jaime L.; Premaratne, Ishani D.; Rohde, Christine; Otterburn, David M.; Morrison, Kerry A.; Lieberman, Michael D.; Pomp, Alfons; Spector, Jason A.

doi:10.1007/s00464-020-07601-9

Cited by 30 publications

(30 citation statements)

References 59 publications

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“…Four articles were retrospective studies providing level III evidence, 18 , 20 , 22 , 23 and 4 were prospective studies offering level II evidence. 19 , 21 , 24 , 25 All studies investigated patients undergoing VHR, with one focusing specifically on patients with a high risk for postoperative complications. 19 Two studies targeted patients specifically undergoing complex abdominal wall reconstruction, 18 , 24 which was defined as bilateral component separation 24 in one and not clearly defined in the other.…”

Section: Resultsmentioning

confidence: 99%

“…While 4 studies included patients with a mesh in the same location, 4 included patients with a mesh in various locations. Of the studies where a mesh was placed in the same location, 2 studies 18 , 24 used onlay and 2 studies 21 , 23 used sublay. One study included inlay placement, 20 but it was used only in 2 cases.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies did not report CDC wound class, 18 , 25 3 studies did not report ASA classification, 18 – 20 , 25 and 4 studies did not report VHWG. 18 , 19 , 21 , 24 …”

Section: Resultsmentioning

confidence: 99%

“…However, the most commonly reported outcome was SSI, which was reported in all included studies, followed by hernia recurrence 18 , 19 , 21 – 25 and reoperation. 18 , 19 , 22 , 24 , 25 …”

Section: Resultsmentioning

confidence: 99%

“…Studies that reported specific surgical site complications for P4HB did so inconsistently. These complications included seroma (6.6%, 21/316), 19 , 20 , 22 – 24 cellulitis (3%, 2/101), 20 – 22 dehiscence (3.0%, 3/101), 21 , 22 nonhealing wound (16%, 11/70), 20 , 22 exposed graft (2/31, 6.5%), 18 mesh exposure (8%, 8/105), 24 skin/soft tissue ischemia/necrosis (3.2%, 1/31), 20 , 21 suture abscess (5%, 5/105), 24 superficial wound breakdown (17%, 18/105), 24 and deep/organ infection (0%, 0/75). 25 Procedural or surgical interventions after initial operation, if specified, included interventional radiology drainage (4.2%, 3/70), 22 debridement (2.9%, 2/70), 22 redo hernia repair (50%, 15/31), 18 superficial infection requiring procedural intervention (4.0%, 3/75), 25 seroma requiring percutaneous drainage (6.7%, 5/75), 25 and mesh explantation (2.2%, 4/180) at an average 26.8 months follow-up.…”

Section: Resultsmentioning

confidence: 99%

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Outcomes of Poly-4-hydroxybutyrate Mesh in Ventral Hernia Repair: A Systematic Review and Pooled Analysis

Mellia

Othman

Naga

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Background: Within the past decade, poly-4-hydroxybutyrate (P4HB) biosynthetic mesh has been introduced as a potential alternative to traditional biologic and synthetic mesh in ventral hernia repair (VHR). The aim of this study was to systematically assess clinical outcomes with the P4HB in VHR. Methods: A literature search identified all articles published in 2000 involving the use of P4HB in VHR. Descriptive statistics were used to synthesize collective data points, including postoperative outcomes. A pooled analysis of postoperative outcomes was performed using chi-square test and Fisher exact test. Results: Across 7 studies, the P4HB was used in 453 patients. The mean rate of surgical site infection (SSI) was 6.8% (31/453), reoperation 10.7% (30/281), and recurrence 9.1% (41/453). At an average follow-up of 26.8 months, the incidence of recurrence was 10.4% (28/270). Onlay was significantly associated with increased recurrence (14.2% versus 4.4%, P = 0.001). Among sublay placements, there was no difference in recurrence in clean (Center for Disease Control [CDC] 1) or contaminated (CDC >1) wounds (2.7% versus 6.1%, P = 0.585), but contaminated wounds were associated with increased SSI (2.7% versus 15.2%, P = 0.028). Ventral Hernia Working Group grade 2 and 3 did not have different incidences of recurrence (8.0% versus 5.1%, P = 0.526) nor SSI (5.1% versus 14.6%, P = 0.265). Conclusions: Overall, clinical outcomes of the P4HB mesh in VHR are acceptable. The P4HB mesh serves as a reliable alternative to traditional synthetic and biologic mesh across a range of defect characteristics and patient health conditions. Further research is needed to better understand the conditions in which it may provide a clinical benefit over traditional mesh types.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Two studies did not report CDC wound class, 18 , 25 3 studies did not report ASA classification, 18 – 20 , 25 and 4 studies did not report VHWG. 18 , 19 , 21 , 24 …”

Section: Resultsmentioning

confidence: 99%

“…However, the most commonly reported outcome was SSI, which was reported in all included studies, followed by hernia recurrence 18 , 19 , 21 – 25 and reoperation. 18 , 19 , 22 , 24 , 25 …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Outcomes of Poly-4-hydroxybutyrate Mesh in Ventral Hernia Repair: A Systematic Review and Pooled Analysis

Mellia

Othman

Naga

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Impact of sterilization technique on electrospun poly(4‐hydroxybutyrate) membranes for biomedical application

Chen,

Yuan,

et al. 2024

J of Applied Polymer Sci

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Bioabsorbable poly(4‐hydroxybutyrate) (P4HB) electrospun membrane has been widely used in various biomedical applications due to its biocompatibility and unique mechanical properties. When commercialization is envisaged, a sterilization procedure aiming to prevent bacterial contamination of biomedical devices is indispensable. Herein, P4HB membranes were sterilized by using different sterilization techniques. It's observed that ethylene oxide (EO), ultraviolet radiation (UV), and electron beam (E‐beam) irradiation do not influence the morphology of fiber membranes. Analysis of the data revealed that E‐beam irradiation sterilization can induce chain scission of P4HB. The EO sterilization process can increase the melting point of P4HB electrospun membranes. None of the sterilization methods showed a significant effect on the hemocompatibility of the P4HB membranes. Furthermore, the cytocompatibility experiment indicated that none of the P4HB membranes had any toxic effects on L929 cells. Taken together, selecting a suitable sterilization method that effectively sterilizes and does less damage during the sterilization process is critical to P4HB membranes for biomedical application.

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Progress of biodegradable polymer application in cardiac occluders

Xu,

Fa,

Yang

et al. 2023

J Biomed Mater Res

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Cardiac septal defect is the most prevalent congenital heart disease and is typically treated with open‐heart surgery under cardiopulmonary bypass. Since the 1990s, with the advancement of interventional techniques and minimally invasive transthoracic closure techniques, cardiac occluder implantation represented by the Amplazter products has been the preferred treatment option. Currently, most occlusion devices used in clinical settings are primarily composed of Nitinol as the skeleton. Nevertheless, long‐term follow‐up studies have revealed various complications related to metal skeletons, including hemolysis, thrombus, metal allergy, cardiac erosion, and even severe atrioventricular block. Thus, occlusion devices made of biodegradable materials have become the focus of research. Over the past two decades, several bioabsorbable cardiac occluders for ventricular septal defect and atrial septal defect have been designed and trialed on animals or humans. This review summarizes the research progress of bioabsorbable cardiac occluders, the advantages and disadvantages of different biodegradable polymers used to fabricate occluders, and discusses future research directions concerning the structures and materials of bioabsorbable cardiac occluders.

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Poly-4-hydroxybutyrate (Phasix™) mesh onlay in complex abdominal wall repair

Cited by 30 publications

References 59 publications

Outcomes of Poly-4-hydroxybutyrate Mesh in Ventral Hernia Repair: A Systematic Review and Pooled Analysis

Outcomes of Poly-4-hydroxybutyrate Mesh in Ventral Hernia Repair: A Systematic Review and Pooled Analysis

Impact of sterilization technique on electrospun poly(4‐hydroxybutyrate) membranes for biomedical application

Progress of biodegradable polymer application in cardiac occluders

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