TY - JOUR
T1 - Mesh-Tissue Integration of Platelet-Rich Plasma-Decellularized Amnion Scaffold-Polypropylene Mesh Sandwiches Implanted in the Vesicovaginal Spaces of Hypoestrogenic Rabbit Models
T2 - Protocol for a Randomized Controlled Trial
AU - Meutia, Alfa Putri
AU - Santoso, Budi Iman
AU - Hestiantoro, Andon
AU - Wuyung, Puspita Eka
AU - Prihartono, Joedo
AU - Boediono, Arief
AU - Djusad, Suskhan
AU - Fauzi, Amir
AU - Budinurdjaja, Pribakti
N1 - Funding Information:
The authors would like to thank Normalina Sandora, MD, MCE, PhD for her help in PRP-DAS-PPM sandwiches preparation and Tri Isyani Tungga Dewi, DVM, MSi for her help in animal care and sample collections. The authors would also like to thank their families and the medical staff for the support given in conducting this study. We received funding from the Indonesian State Ministry for Research and Technology as a PhD grant (grant NKB-301/UN2.RST/HKP.05.00/2021).
Publisher Copyright:
© 2022 JMIR Publications Inc. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Background: Mesh-augmented surgery with polypropylene meshes (PPMs) is often used in urogynecology and pelvic reconstructive surgery. However, the various complications that arise from its integration process have resulted in a decrease in the number of mesh-augmented surgeries performed worldwide. An approach to improving mesh-tissue integration is coating PPMs with anti-inflammatory and wound-healing molecules, such as platelet-rich plasma (PRP), which is a component of biotechnologies that are capable of accelerating wound healing. Estrogen is also known to have a beneficial effect on wound remodeling; therefore, a hypoestrogenic status may have negative implications for wound healing. The mechanism of how PRP plays a role in wound remodeling, especially among individuals in a hypoestrogenic state, has not been fully described until now. Objective: Our aim is to investigate the impact of applying PRP to PPMs in hypoestrogenic rabbit models. Methods: Our study will be a randomized controlled trial involving hypoestrogenic rabbit models. Samples were categorized into either the PRP group or the PPM group (1:1 ratio), with a minimum sample size of 16 in each arm, via simple random sampling. All samples were put into a hypoestrogenic state via bilateral oophorectomy. After confirming a decrease in estradiol level, the meshes were implanted in the vesicovaginal space. The samples were euthanized on the 14th, 28th, or 90th day of the surgery. The mesh-tissue integration process will be analyzed based on inflammatory parameters (inflammatory infiltrate, interleukin-17, and interleukin-1B expression); angiogenesis (CD31 expression); and collagen deposition, which will be assessed by using Masson trichrome staining. Results: Our study is in the protocol development stage. A preliminary study regarding its feasibility, including the feasibility of the preparation of hypoestrogenic rabbit models, mesh implantation in the rabbits' vesicovaginal spaces, the PRP and amnion scaffold, started in February 2022. The results of our study are expected to be available by the end of 2022. Conclusions: Our randomized controlled trial is designed to provide high-quality evidence on the effect of applying a PRP-decellularized amnion scaffold to PPMs in the vesicovaginal spaces of hypoestrogenic rabbit models.
AB - Background: Mesh-augmented surgery with polypropylene meshes (PPMs) is often used in urogynecology and pelvic reconstructive surgery. However, the various complications that arise from its integration process have resulted in a decrease in the number of mesh-augmented surgeries performed worldwide. An approach to improving mesh-tissue integration is coating PPMs with anti-inflammatory and wound-healing molecules, such as platelet-rich plasma (PRP), which is a component of biotechnologies that are capable of accelerating wound healing. Estrogen is also known to have a beneficial effect on wound remodeling; therefore, a hypoestrogenic status may have negative implications for wound healing. The mechanism of how PRP plays a role in wound remodeling, especially among individuals in a hypoestrogenic state, has not been fully described until now. Objective: Our aim is to investigate the impact of applying PRP to PPMs in hypoestrogenic rabbit models. Methods: Our study will be a randomized controlled trial involving hypoestrogenic rabbit models. Samples were categorized into either the PRP group or the PPM group (1:1 ratio), with a minimum sample size of 16 in each arm, via simple random sampling. All samples were put into a hypoestrogenic state via bilateral oophorectomy. After confirming a decrease in estradiol level, the meshes were implanted in the vesicovaginal space. The samples were euthanized on the 14th, 28th, or 90th day of the surgery. The mesh-tissue integration process will be analyzed based on inflammatory parameters (inflammatory infiltrate, interleukin-17, and interleukin-1B expression); angiogenesis (CD31 expression); and collagen deposition, which will be assessed by using Masson trichrome staining. Results: Our study is in the protocol development stage. A preliminary study regarding its feasibility, including the feasibility of the preparation of hypoestrogenic rabbit models, mesh implantation in the rabbits' vesicovaginal spaces, the PRP and amnion scaffold, started in February 2022. The results of our study are expected to be available by the end of 2022. Conclusions: Our randomized controlled trial is designed to provide high-quality evidence on the effect of applying a PRP-decellularized amnion scaffold to PPMs in the vesicovaginal spaces of hypoestrogenic rabbit models.
KW - pelvic organ prolapse
KW - platelet-rich plasma
KW - vaginal mesh
UR - http://www.scopus.com/inward/record.url?scp=85136997973&partnerID=8YFLogxK
U2 - 10.2196/37942
DO - 10.2196/37942
M3 - Article
AN - SCOPUS:85136997973
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 8
M1 - e37942
ER -