Clinical trial NCT06404931 - References

Prolapse; Female — Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Citation(s)

•   Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group
  Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521. Erratum In: N Engl J Med. 2013 Jan 24;368(4):394.
•   Botros SM, Sand PK, Beaumont JL, Abramov Y, Miller JJ, Goldberg RP
  Arcus-anchored acellular dermal graft compared to anterior colporrhaphy for stage II cystoceles and beyond. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1265-71. doi: 10.1007/s00192-009-0933-7. Epub 2009 Jun 17.
•   Chung SY, Franks M, Smith CP, Lee JY, Lu SH, Chancellor M
  Technique of combined pubovaginal sling and cystocele repair using a single piece of cadaveric dermal graft. Urology. 2002 Apr;59(4):538-41. doi: 10.1016/s0090-4295(01)01611-9.
•   Clemons JL, Myers DL, Aguilar VC, Arya LA
  Vaginal paravaginal repair with an AlloDerm graft. Am J Obstet Gynecol. 2003 Dec;189(6):1612-8; discussion 1618-9. doi: 10.1016/s0002-9378(03)00929-3.
•   Curtiss N, Duckett J
  A long-term cohort study of surgery for recurrent prolapse comparing mesh augmented anterior repairs to anterior colporrhaphy. Gynecol Surg. 2018;15(1):1. doi: 10.1186/s10397-017-1035-z. Epub 2018 Jan 10.
•   Dietz HP
  Ultrasound imaging of the pelvic floor. Part II: three-dimensional or volume imaging. Ultrasound Obstet Gynecol. 2004 Jun;23(6):615-25. doi: 10.1002/uog.1072.
•   Flynn BJ, Webster GD
  Surgical management of the apical vaginal defect. Curr Opin Urol. 2002 Jul;12(4):353-8. doi: 10.1097/00042307-200207000-00015.
•   Griffey S, Schwade ND, Wright CG
  Particulate dermal matrix as an injectable soft tissue replacement material. J Biomed Mater Res. 2001;58(1):10-5. doi: 10.1002/1097-4636(2001)58:13.0.co;2-e.
•   Guo X, Mu D, Gao F
  Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: A systematic review and meta-analysis. Int J Surg. 2017 Apr;40:1-7. doi: 10.1016/j.ijsu.2017.02.008. Epub 2017 Feb 14.
•   Kohli N, Miklos JR
  Dermal graft-augmented rectocele repair. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):146-9. doi: 10.1007/s00192-002-1013-4. Epub 2003 Feb 13.
•   Menon NG, Rodriguez ED, Byrnes CK, Girotto JA, Goldberg NH, Silverman RP
  Revascularization of human acellular dermis in full-thickness abdominal wall reconstruction in the rabbit model. Ann Plast Surg. 2003 May;50(5):523-7. doi: 10.1097/01.SAP.0000044252.76804.6B. Erratum In: Ann Plast Surg. 2003 Aug;51(2):228.
•   Miklos JR, Kohli N, Moore R
  Levatorplasty release and reconstruction of rectovaginal septum using allogenic dermal graft. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(1):44-6. doi: 10.1007/s001920200009.
•   NHS Improvement, NHS England
  Letter to Acute Trust CEOs and Medical Directors. 2018;(July 2017). Available from: www.england.nhs.uk
•   Perez ML, Castells-Sala C, Lopez-Chicon P, Nieto-Nicolau N, Aiti A, Farinas O, Casaroli-Marano RP, Porta O, Vilarrodona A
  Fast protocol for the processing of split-thickness skin into decellularized human dermal matrix. Tissue Cell. 2021 Oct;72:101572. doi: 10.1016/j.tice.2021.101572. Epub 2021 Jun 4.
•   Pero M, Casani L, Castells-Sala C, Perez ML, Moga Naranjo E, Juan-Babot O, Alserawan De Lamo L, Lopez-Chicon P, Vilarrodona Serrat A, Badimon L, Porta Roda O
  Rabbit as an animal model for the study of biological grafts in pelvic floor dysfunctions. Sci Rep. 2021 May 18;11(1):10545. doi: 10.1038/s41598-021-89698-z.
•   Rodrigo N, Wong V, Shek KL, Martin A, Dietz HP
  The use of 3-dimensional ultrasound of the pelvic floor to predict recurrence risk after pelvic reconstructive surgery. Aust N Z J Obstet Gynaecol. 2014 Jun;54(3):206-11. doi: 10.1111/ajo.12171. Epub 2014 Feb 18.
•   Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E
  An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961.
•   Salzberg CA
  Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006 Jul;57(1):1-5. doi: 10.1097/01.sap.0000214873.13102.9f.
•   Unger CA, Barber MD
  Vaginal Mesh in Pelvic Reconstructive Surgery: Controversies, Current Use, and Complications. Clin Obstet Gynecol. 2015 Dec;58(4):740-53. doi: 10.1097/GRF.0000000000000148.
•   Vollebregt A, Fischer K, Gietelink D, van der Vaart CH
  Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. BJOG. 2011 Nov;118(12):1518-27. doi: 10.1111/j.1471-0528.2011.03082.x. Epub 2011 Aug 22.
•   Ward RM, Sung VW, Clemons JL, Myers DL
  Vaginal paravaginal repair with an AlloDerm graft: Long-term outcomes. Am J Obstet Gynecol. 2007 Dec;197(6):670.e1-5. doi: 10.1016/j.ajog.2007.08.067.
•   Wong NKL, Cheung RYK, Lee LL, Wan OYK, Choy KW, Chan SSC
  Women with advanced pelvic organ prolapse and levator ani muscle avulsion would significantly benefit from mesh repair surgery. Ultrasound Obstet Gynecol. 2021 Apr;57(4):631-638. doi: 10.1002/uog.23109.

Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial

Details for clinical trial NCT06404931