@article{a6c41ec4751f4e56bedd181f864dd287,
title = "Development of a Chronic Canine Ovariohysterectomy Model to Evaluate Vaginal Cuff Healing Using Two Closure Systems",
abstract = "Background and Purpose. This study established a suitable animal model of ovariohysterectomy; characterized the course and pattern of vaginal healing after ovariohysterectomy; and compared healing obtained after closure of the vaginal cuff with a novel cuff-closure device (Zip-stitch{\textregistered} clips) and VICRYL{\textregistered} sutures. Research Design and Study Sample. This prospective, randomized, controlled, blinded animal study was conducted in 27 mongrel hounds according to an IACUC-approved protocol. Each animal underwent ovariohysterectomy followed by vaginal cuff closure with Zip-stitch or VICRYL. At two or six weeks, animals were sacrificed for gross and histological analysis. Data Collection. The primary endpoint was the difference in the fraction of vaginal cuff healed six weeks after application of the closure device. Secondary endpoints included histopathologic cellular and tissue responses, including inflammation, necrosis, infection, and vascular and muscle changes. Results. In the test group, there were two distinct locations where fibrotic or granular tissue fusion between the anterior and posterior vaginal walls was observed: in tissue “captured” by a clip or in tissue around the clip. The fraction of the vaginal cuff healed was similar in animals treated with Zip-stitch clips and those treated with sutures at six weeks (68±10% vs 67±18%; P=.148, test for non-inferiority) after surgery. The test article performed similarly or better than the control article in terms of the intensity or extent of the secondary endpoints. Conclusions. Subject to further confirmation, this study supports Zip-stitch clips as a method to maintain immediate post-operative approximation of the vaginal cuff leading to healing but did not achieve statistical significance in its primary endpoint.",
keywords = "NOTES, biomedical engineering, gynecologic laparoscopy, robotic surgery, surgical oncology",
author = "David Wiseman and Hanzlik, {Josa A.} and Richardson, {James A.} and Shelton, {John M.} and Evers, {Bret M.} and Diamond, {Michael P.} and Ryan Brown and Mazzucco, {Dan C.}",
note = "Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Wiseman reports grants from the National Science Foundation and personal fees from Synechion, Inc., during the conduct of the study, and personal fees from Synechion outside the submitted work. Synechion is a contract R&D development company compensated by ZSX with both cash and equity. Dr Hanzlik{\textquoteright}s work during the conduct of the study was funded by a grant from the National Science Foundation; she also received personal fees from ZSX Medical outside the submitted work. Dr Richardson reports personal fees from Synechion during the conduct of the study. Dr Shelton reports personal fees from University of Texas Southwestern during the conduct of the study. Dr Evers reports personal fees from Synechion during the conduct of the study. Dr Diamond and Mr Brown report personal fees from ZSX Medical during the conduct of the study and outside the submitted work. Dr Mazzucco reports grants from the National Science Foundation and personal fees from ZSX Medical during the conduct of the study; in addition, Dr Mazzucco reports personal fees from ZSX Medical outside the submitted work. In addition, Dr Mazzucco has patents 8,852,211, 9,358,008, 9,700,324, and 10 278 700 issued and patent 16/680 999 pending. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded, in part, by National Science Foundation Small Business Innovation Research Grant 1430810. Publisher Copyright: {\textcopyright} The Author(s) 2021.",
year = "2022",
month = apr,
doi = "10.1177/15533506211039307",
language = "English (US)",
volume = "29",
pages = "183--194",
journal = "Surgical Innovation",
issn = "1553-3506",
publisher = "SAGE Publications Inc.",
number = "2",
}