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.

Autor: Meutia AP; Doctoral Program in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.; Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia., Santoso BI; Doctoral Program in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia., Hestiantoro A; Doctoral Program in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia., Wuyung PE; Department of Pathology Anatomy, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia., Prihartono J; Department of Community Medicine, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo National Referral Hospital, Jakarta, Indonesia., Boediono A; Department of Anatomy, Physiology and Pharmacology, Institut Pertanian Bogor University, Bogor, Indonesia., Djusad S; Doctoral Program in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia., Fauzi A; Division of Urogynecology and Reconstructive Surgery, Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Sriwijaya - Dr. Mohammad Hoesin General Hospital, Palembang, Indonesia., Budinurdjaja P; Division of Urogynecology and Reconstructive Surgery, Department of Obstetrics Obstetrics and Gynecology, Faculty of Medicine, Universitas Lambung Mangkurat - Ulin General Hospital, Kalimantan Selatan, Indonesia.
Jazyk: angličtina
Zdroj: JMIR research protocols [JMIR Res Protoc] 2022 Aug 09; Vol. 11 (8), pp. e37942. Date of Electronic Publication: 2022 Aug 09.
DOI: 10.2196/37942
Abstrakt: 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.
International Registered Report Identifier (irrid): PRR1-10.2196/37942.
(©Alfa Putri Meutia, Budi Iman Santoso, Andon Hestiantoro, Puspita Eka Wuyung, Joedo Prihartono, Arief Boediono, Suskhan Djusad, Amir Fauzi, Pribakti Budinurdjaja. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2022.)
Databáze: MEDLINE