NCT01060046|Completed
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Sponsor study identifier
observational
241
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)The purpose of this study is to investigate what happens to biologic mesh in the body over time on a molecular level. To date, it is not known what agents, enzymes, or proteins are interacting at the implantation site that contributes to mesh remodeling and/or degradation. Investigators on this project will identify patients with previously placed mesh who are needing reoperation on the same site and take a biopsy of the mesh during the normal course of surgery. Basic data surrounding the surgical procedure will be collected. The mesh samples will be analyzed for enzymes and proteins and examined histologically for processes that signify remodeling and/or degradation. Control patients will undergo biopsy of abdominal fascia at laparoscopic trocar sites in a manner that will not affect the outcome(s) of their procedure or other risk to the incision site.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 28, 2010
Actual (reported)February 1, 2010
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)All patients undergoing a repeat operation to repair a recurrent hernia or to revise a surgical site which has been previously repaired using a biologic mesh.
Any patient undergoing a surgical procedure where fascial biopsy would not compromise the integrity of the procedure.
Patients will be selected from the practices of the surgeons listed on the investigational team.
Contact the study team to confirm eligibility.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Buinewicz B, Rosen B. Acellular cadaveric dermis (AlloDerm): a new alternative for abdominal hernia repair. Ann Plast Surg. 2004 Feb;52(2):188-94. doi: 10.1097/01.sap.0000100895.41198.27.
Burger JW, Halm JA, Wijsmuller AR, ten Raa S, Jeekel J. Evaluation of new prosthetic meshes for ventral hernia repair. Surg Endosc. 2006 Aug;20(8):1320-5. doi: 10.1007/s00464-005-0706-4. Epub 2006 Jul 24.
Biopsy samples of previously implanted biologic meshes, biopsy samples of native abdominal wall fascia
Brent D Matthews, MD
Washington University School of Medicine
Corey Deeken, PhD
Washington University School of Medicine
241 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2010
First Posted
February 1, 2010
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Prospective Study of Ventral Hernia Repair
Butler CE, Prieto VG. Reduction of adhesions with composite AlloDerm/polypropylene mesh implants for abdominal wall reconstruction. Plast Reconstr Surg. 2004 Aug;114(2):464-73. doi: 10.1097/01.prs.0000132670.81794.7e.
Butler CE. The role of bioprosthetics in abdominal wall reconstruction. Clin Plast Surg. 2006 Apr;33(2):199-211, v-vi. doi: 10.1016/j.cps.2005.12.009.
Butler CE, Langstein HN, Kronowitz SJ. Pelvic, abdominal, and chest wall reconstruction with AlloDerm in patients at increased risk for mesh-related complications. Plast Reconstr Surg. 2005 Oct;116(5):1263-75; discussion 1276-7. doi: 10.1097/01.prs.0000181692.71901.bd.
Dalla Vecchia L, Engum S, Kogon B, Jensen E, Davis M, Grosfeld J. Evaluation of small intestine submucosa and acellular dermis as diaphragmatic prostheses. J Pediatr Surg. 1999 Jan;34(1):167-71. doi: 10.1016/s0022-3468(99)90250-6.
Diaz S, Brunt LM, Klingensmith ME, Frisella PM, Soper NJ. Laparoscopic paraesophageal hernia repair, a challenging operation: medium-term outcome of 116 patients. J Gastrointest Surg. 2003 Jan;7(1):59-67. doi: 10.1016/S1091-255X(02)00151-8.
Draaisma WA, Gooszen HG, Tournoij E, Broeders IA. Controversies in paraesophageal hernia repair: a review of literature. Surg Endosc. 2005 Oct;19(10):1300-8. doi: 10.1007/s00464-004-2275-3. Epub 2005 Aug 4.
Franklin ME Jr, Gonzalez JJ Jr, Glass JL. Use of porcine small intestinal submucosa as a prosthetic device for laparoscopic repair of hernias in contaminated fields: 2-year follow-up. Hernia. 2004 Aug;8(3):186-9. doi: 10.1007/s10029-004-0208-7. Epub 2004 Feb 26.
Holton LH 3rd, Kim D, Silverman RP, Rodriguez ED, Singh N, Goldberg NH. Human acellular dermal matrix for repair of abdominal wall defects: review of clinical experience and experimental data. J Long Term Eff Med Implants. 2005;15(5):547-58. doi: 10.1615/jlongtermeffmedimplants.v15.i5.70.
Kish KJ, Buinewicz BR, Morris JB. Acellular dermal matrix (AlloDerm): new material in the repair of stoma site hernias. Am Surg. 2005 Dec;71(12):1047-50.
Kolker AR, Brown DJ, Redstone JS, Scarpinato VM, Wallack MK. Multilayer reconstruction of abdominal wall defects with acellular dermal allograft (AlloDerm) and component separation. Ann Plast Surg. 2005 Jul;55(1):36-41; discussion 41-2. doi: 10.1097/01.sap.0000168248.83197.d4.
Miller RS, Morris JA Jr, Diaz JJ Jr, Herring MB, May AK. Complications after 344 damage-control open celiotomies. J Trauma. 2005 Dec;59(6):1365-71; discussion 1371-4. doi: 10.1097/01.ta.0000196004.49422.af.
Oelschlager BK, Barreca M, Chang L, Pellegrini CA. The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique. Am J Surg. 2003 Jul;186(1):4-8. doi: 10.1016/s0002-9610(03)00114-4.
Oelschlager BK, Pellegrini CA, Hunter J, Soper N, Brunt M, Sheppard B, Jobe B, Polissar N, Mitsumori L, Nelson J, Swanstrom L. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg. 2006 Oct;244(4):481-90. doi: 10.1097/01.sla.0000237759.42831.03.
Scott BG, Welsh FJ, Pham HQ, Carrick MM, Liscum KR, Granchi TS, Wall MJ Jr, Mattox KL, Hirshberg A. Early aggressive closure of the open abdomen. J Trauma. 2006 Jan;60(1):17-22. doi: 10.1097/01.ta.0000200861.96568.bb.
Silverman RP, Li EN, Holton LH 3rd, Sawan KT, Goldberg NH. Ventral hernia repair using allogenic acellular dermal matrix in a swine model. Hernia. 2004 Dec;8(4):336-42. doi: 10.1007/s10029-004-0241-6.
Cavallo JA, Roma AA, Jasielec MS, Ousley J, Creamer J, Pichert MD, Baalman S, Frisella MM, Matthews BD, Deeken CR. Remodeling characteristics and collagen distribution in biological scaffold materials explanted from human subjects after abdominal soft tissue reconstruction: an analysis of scaffold remodeling characteristics by patient risk factors and surgical site classifications. Ann Surg. 2015 Feb;261(2):405-15. doi: 10.1097/SLA.0000000000000471.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
May 14, 2018
Record last verified: 2018-05
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