Mesh-Tissue Integration of Platelet-Rich Plasma-Decellularized Amnion Scaffold-Polypropylene Mesh Sandwiches Implanted in the Vesicovaginal Spaces of Hypoestrogenic Rabbit Models: Protocol for a Randomized Controlled Trial

Alfa Putri Meutia, Budi Iman Santoso, Andon Hestiantoro, Puspita Eka Wuyung, Joedo Prihartono, Arief Boediono, Suskhan Djusad, Amir Fauzi, Pribakti Budinurdjaja

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Article numbere37942
JournalJMIR Research Protocols
Volume11
Issue number8
DOIs
Publication statusPublished - 1 Aug 2022
Externally publishedYes

Keywords

  • pelvic organ prolapse
  • platelet-rich plasma
  • vaginal mesh

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