A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol
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A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair : a research protocol. / van Rooijen, M M J; Jairam, A P; Tollens, T; Jørgensen, L N; de Vries Reilingh, T S; Piessen, G; Köckerling, F; Miserez, M; Windsor, A C J; Berrevoet, F; Fortelny, R H; Dousset, B; Woeste, G; van Westreenen, H L; Gossetti, F; Lange, J F; Tetteroo, G W M; Koch, A; Kroese, L F; Jeekel, J.
I: BMC Surgery, Bind 18, Nr. 1, 104, 2018, s. 1-9.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair
T2 - a research protocol
AU - van Rooijen, M M J
AU - Jairam, A P
AU - Tollens, T
AU - Jørgensen, L N
AU - de Vries Reilingh, T S
AU - Piessen, G
AU - Köckerling, F
AU - Miserez, M
AU - Windsor, A C J
AU - Berrevoet, F
AU - Fortelny, R H
AU - Dousset, B
AU - Woeste, G
AU - van Westreenen, H L
AU - Gossetti, F
AU - Lange, J F
AU - Tetteroo, G W M
AU - Koch, A
AU - Kroese, L F
AU - Jeekel, J
PY - 2018
Y1 - 2018
N2 - BACKGROUND: Incisional 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.METHODS: A 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.CONCLUSION: Based 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 REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .
AB - BACKGROUND: Incisional 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.METHODS: A 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.CONCLUSION: Based 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 REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .
KW - Adult
KW - Aged
KW - Female
KW - Hernia, Ventral/surgery
KW - Herniorrhaphy/methods
KW - Humans
KW - Incisional Hernia/etiology
KW - Laparotomy/adverse effects
KW - Middle Aged
KW - Postoperative Complications/epidemiology
KW - Prospective Studies
KW - Quality of Life
KW - Recurrence
KW - Surgical Mesh
U2 - 10.1186/s12893-018-0439-7
DO - 10.1186/s12893-018-0439-7
M3 - Journal article
C2 - 30458747
VL - 18
SP - 1
EP - 9
JO - BMC Surgery
JF - BMC Surgery
SN - 1471-2482
IS - 1
M1 - 104
ER -
ID: 222095607