{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["129(7)"],"submitter":["Diedrich CM"],"funding":["Tepha, Inc., Lexington, MA, USA"],"pubmed_abstract":["<h4>Objective</h4>To evaluate the host- and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with the response to polypropylene (PP) mesh.<h4>Design</h4>In vivo animal experiment.<h4>Setting</h4>KU Leuven Center for Surgical Technologies.<h4>Population</h4>Fourteen parous female Mule sheep.<h4>Methods</h4>P4HB scaffolds were surgically implanted in the posterior vaginal wall of sheep. The comparative PP mesh data were obtained from an identical study protocol performed previously.<h4>Main outcome measures</h4>Gross necropsy, host response and biomechanical evaluation of explants, and the in vivo P4HB scaffold degradation were evaluated at 60- and 180-days post-implantation. Data are reported as mean ± standard deviation (SD) or standard error of the mean (SEM).<h4>Results</h4>Gross necropsy revealed no implant-related adverse events using P4HB scaffolds. The tensile stiffness of the P4HB explants increased at 180-days (12.498 ± 2.66 N/mm SEM [p =0.019]) as compared to 60-days (4.585 ± 1.57 N/mm) post-implantation, while P4HB degraded gradually. P4HB scaffolds exhibited excellent tissue integration with dense connective tissue and a moderate initial host response. P4HB scaffolds induced a significantly higher M2/M1 ratio (1.70 ± 0.67 SD, score 0-4), as compared to PP mesh(0.99 ± 0.78 SD, score 0-4) at 180-days.<h4>Conclusions</h4>P4HB scaffold facilitated a gradual load transfer to vaginal tissue over time. The fully absorbable P4HB scaffold, in comparison to PP mesh, has a favorable host response with comparable load-bearing capacity. If these results are also observed at longer follow-up in-vivo, a clinical study using P4HB for vaginal POP surgery may be warranted to demonstrate efficacy.<h4>Tweetable abstract</h4>Degradable vaginal P4HB implant might be a solution for treatment of POP."],"journal":["BJOG : an international journal of obstetrics and gynaecology"],"pagination":["1039-1049"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9303173"],"repository":["biostudies-literature"],"pubmed_title":["Evaluation of the short-term host response and biomechanics of an absorbable poly-4-hydroxybutyrate scaffold in a sheep model following vaginal implantation."],"pmcid":["PMC9303173"],"pubmed_authors":["Diedrich CM","Hympanova L","Deprest J","Guler Z","Mazza E","Vodegel E","Roovers JP","Zundel M"],"additional_accession":[]},"is_claimable":false,"name":"Evaluation of the short-term host response and biomechanics of an absorbable poly-4-hydroxybutyrate scaffold in a sheep model following vaginal implantation.","description":"<h4>Objective</h4>To evaluate the host- and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with the response to polypropylene (PP) mesh.<h4>Design</h4>In vivo animal experiment.<h4>Setting</h4>KU Leuven Center for Surgical Technologies.<h4>Population</h4>Fourteen parous female Mule sheep.<h4>Methods</h4>P4HB scaffolds were surgically implanted in the posterior vaginal wall of sheep. The comparative PP mesh data were obtained from an identical study protocol performed previously.<h4>Main outcome measures</h4>Gross necropsy, host response and biomechanical evaluation of explants, and the in vivo P4HB scaffold degradation were evaluated at 60- and 180-days post-implantation. Data are reported as mean ± standard deviation (SD) or standard error of the mean (SEM).<h4>Results</h4>Gross necropsy revealed no implant-related adverse events using P4HB scaffolds. The tensile stiffness of the P4HB explants increased at 180-days (12.498 ± 2.66 N/mm SEM [p =0.019]) as compared to 60-days (4.585 ± 1.57 N/mm) post-implantation, while P4HB degraded gradually. P4HB scaffolds exhibited excellent tissue integration with dense connective tissue and a moderate initial host response. P4HB scaffolds induced a significantly higher M2/M1 ratio (1.70 ± 0.67 SD, score 0-4), as compared to PP mesh(0.99 ± 0.78 SD, score 0-4) at 180-days.<h4>Conclusions</h4>P4HB scaffold facilitated a gradual load transfer to vaginal tissue over time. The fully absorbable P4HB scaffold, in comparison to PP mesh, has a favorable host response with comparable load-bearing capacity. If these results are also observed at longer follow-up in-vivo, a clinical study using P4HB for vaginal POP surgery may be warranted to demonstrate efficacy.<h4>Tweetable abstract</h4>Degradable vaginal P4HB implant might be a solution for treatment of POP.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jun","modification":"2025-04-22T05:58:51.963Z","creation":"2022-08-08T22:18:53.97Z"},"accession":"S-EPMC9303173","cross_references":{"pubmed":["34865300"],"doi":["10.1111/1471-0528.17040"]}}