ArticleBMC surgery2018
A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.
Article in BMC surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720042 (A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Bioabsorbable mesh use in midline abdominal wall prophylaxis and repair achieving fascial closure: a cross-sectional review of stage of innovation.Hernia : the journal of hernias and abdominal wall surgery · 2021Pooled it
- Mesh exposure after ventral hernia repair with onlay biosynthetic mesh: a retrospective review of associated risk factors and management strategies.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- A Review of Abdominal Meshes for Hernia Repair-Current Status and Emerging Solutions.Materials (Basel, Switzerland) · 2023Review
- Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review.Frontiers in surgery · 2023Article
- Establishing Peer Consensus About the Use of Long-Term Biosynthetic Absorbable Mesh for Hernia (Grades 2-3) as the Standard of Care.World journal of surgery · 2022Article
- Polyhydroxyalkanoates (PHAs) as Biomaterials in Tissue Engineering: Production, Isolation, Characterization.Materials (Basel, Switzerland) · 2022Review
- Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.Hernia : the journal of hernias and abdominal wall surgery · 2022Article
- Current Advances towards 4-Hydroxybutyrate Containing Polyhydroxyalkanoates Production for Biomedical Applications.Molecules (Basel, Switzerland) · 2021Review
- Biosynthetic Resorbable Prosthesis is Useful in Single-Stage Management of Chronic Mesh Infection After Abdominal Wall Hernia Repair.World journal of surgery · 2021Article
- Article
- Incidence of Incisional Hernia After Emergency Subcostal Unilateral Laparotomy: Does Augmentation Prophylaxis Play a Role?World journal of surgery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIncisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.
methodsA total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery.
conclusionBased on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients.
trial registrationThe trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .
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