Analysis and Characterization of Biologic Implants

NCT01060046 | Completed

• 1 other identifier: 201101959
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia; Post-mastectomy Breast Reconstruction

Keywords

biologic mesh; ventral hernia repair; breast reconstruction; MMPs

Study Arms (2)

Patients with previously implanted biologic mesh

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.

Control patients

Any patient undergoing a surgical procedure where fascial biopsy would not compromise the integrity of the procedure.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the practices of the surgeons listed on the investigational team.

You may qualify if:

• All patients undergoing a repeat operation to repair a recurrent hernia or revise a surgical site which has been previously repaired using one of the aforementioned biologic meshes. Any patient undergoing a surgical procedure where fascial biopsy would not compromise the integrity of the procedure.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (18)

• 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.

  PMID: 14745271 BACKGROUND

• 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.

  PMID: 16865616 BACKGROUND

• 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.

  PMID: 15277815 BACKGROUND

• 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.

  PMID: 16638463 BACKGROUND

• 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.

  PMID: 16217466 BACKGROUND

• 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.

  PMID: 10022165 BACKGROUND

• 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.

  PMID: 12559186 BACKGROUND

• 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.

  PMID: 16151684 BACKGROUND

• 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.

  PMID: 14991410 BACKGROUND

• 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.

  PMID: 16218902 BACKGROUND

• 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.

  PMID: 16447477 BACKGROUND

• 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.

  PMID: 15985789 BACKGROUND

• 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.

  PMID: 16394910 BACKGROUND

• 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.

  PMID: 12842738 BACKGROUND

• 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.

  PMID: 16998356 BACKGROUND

• 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.

  PMID: 16456431 BACKGROUND

• 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.

  PMID: 15185131 BACKGROUND

• 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.

  PMID: 24374547 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy samples of previously implanted biologic meshes, biopsy samples of native abdominal wall fascia

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent D Matthews, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Corey Deeken, PhD

  Washington University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: August 1, 2007
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)