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Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial

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Harvard

van Rooijen, MM, Jairam, AP, Tollens, T, Jørgensen, LN, de Vries Reilingh, TS, Piessen, G, Köckerling, F, Miserez, M, Windsor, AC, Berrevoet, F, Fortelny, RH, Dousset, B, Woeste, G, van Westreenen, HL, Gossetti, F, Lange, JF, Tetteroo, GW, Koch, A, Kroese, LF & Jeekel, J 2020, 'Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial', International Surgery, vol. 83, pp. 31-36. https://doi.org/10.1016/j.ijsu.2020.08.053

APA

van Rooijen, M. M., Jairam, A. P., Tollens, T., Jørgensen, L. N., de Vries Reilingh, T. S., Piessen, G., Köckerling, F., Miserez, M., Windsor, A. C., Berrevoet, F., Fortelny, R. H., Dousset, B., Woeste, G., van Westreenen, H. L., Gossetti, F., Lange, J. F., Tetteroo, G. W., Koch, A., Kroese, L. F., & Jeekel, J. (2020). Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial. International Surgery, 83, 31-36. https://doi.org/10.1016/j.ijsu.2020.08.053

CBE

van Rooijen MM, Jairam AP, Tollens T, Jørgensen LN, de Vries Reilingh TS, Piessen G, Köckerling F, Miserez M, Windsor AC, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GW, Koch A, Kroese LF, Jeekel J. 2020. Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial. International Surgery. 83:31-36. https://doi.org/10.1016/j.ijsu.2020.08.053

MLA

Vancouver

Author

van Rooijen, Mathilde Mj ; Jairam, An P ; Tollens, Tim ; Jørgensen, Lars N ; de Vries Reilingh, Tammo S ; Piessen, Guillaume ; Köckerling, Ferdinand ; Miserez, Marc ; Windsor, Alastair Cj ; Berrevoet, Frederik ; Fortelny, René H ; Dousset, Bertrand ; Woeste, Guido ; van Westreenen, Henderik L ; Gossetti, Francesco ; Lange, Johan F ; Tetteroo, Geert Wm ; Koch, Andreas ; Kroese, Leonard F ; Jeekel, Johannes. / Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias : A prospective, multi-center, single-arm trial. In: International Surgery. 2020 ; Vol. 83. pp. 31-36.

Bibtex

@article{eea9dfff9dab410aab25579b32fa9f5d,
title = "Outcomes of a new slowly resorbable biosynthetic mesh (Phasix{\texttrademark}) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial",
abstract = "BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix{\texttrademark}) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix{\texttrademark} Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.RESULTS: In total, 84 patients were treated with Phasix{\texttrademark} Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.CONCLUSION: Phasix{\texttrademark} Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.",
author = "{van Rooijen}, {Mathilde Mj} and Jairam, {An P} and Tim Tollens and J{\o}rgensen, {Lars N} and {de Vries Reilingh}, {Tammo S} and Guillaume Piessen and Ferdinand K{\"o}ckerling and Marc Miserez and Windsor, {Alastair Cj} and Frederik Berrevoet and Fortelny, {Ren{\'e} H} and Bertrand Dousset and Guido Woeste and {van Westreenen}, {Henderik L} and Francesco Gossetti and Lange, {Johan F} and Tetteroo, {Geert Wm} and Andreas Koch and Kroese, {Leonard F} and Johannes Jeekel",
note = "Copyright {\textcopyright} 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.",
year = "2020",
month = nov,
doi = "10.1016/j.ijsu.2020.08.053",
language = "English",
volume = "83",
pages = "31--36",
journal = "International Surgery",
issn = "0020-8868",
publisher = "International College of Surgeons",

}

RIS

TY - JOUR

T1 - Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias

T2 - A prospective, multi-center, single-arm trial

AU - van Rooijen, Mathilde Mj

AU - Jairam, An P

AU - Tollens, Tim

AU - Jørgensen, Lars N

AU - de Vries Reilingh, Tammo S

AU - Piessen, Guillaume

AU - Köckerling, Ferdinand

AU - Miserez, Marc

AU - Windsor, Alastair Cj

AU - Berrevoet, Frederik

AU - Fortelny, René H

AU - Dousset, Bertrand

AU - Woeste, Guido

AU - van Westreenen, Henderik L

AU - Gossetti, Francesco

AU - Lange, Johan F

AU - Tetteroo, Geert Wm

AU - Koch, Andreas

AU - Kroese, Leonard F

AU - Jeekel, Johannes

N1 - Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

PY - 2020/11

Y1 - 2020/11

N2 - BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.

AB - BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.

U2 - 10.1016/j.ijsu.2020.08.053

DO - 10.1016/j.ijsu.2020.08.053

M3 - Journal article

C2 - 32931978

VL - 83

SP - 31

EP - 36

JO - International Surgery

JF - International Surgery

SN - 0020-8868

ER -

ID: 62417222