- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01060046
Analysis and Characterization of Biologic Implants
7. mai 2018 oppdatert av: Washington University School of Medicine
Analysis and Characterization of in Vivo Tissue Remodeling in Routine Biologic Mesh Explants From Patients Undergoing Reoperation for Recurrent Hernia or Revision of a Prior Surgical Site
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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Several such biologic meshes have now been developed and marketed for use in hernia repair and soft tissue reconstruction.
These biologics include one product derived from porcine intestinal submucosa (SurgisisTM, Cook Medical), another derived from porcine dermis (CollaMendTM, C.R. Bard Inc.) and several others derived from decellularized human dermis, such as AlloDermTM (LifeCell Corp.), AlloMaxTM (C.R. Bard Inc.), and FlexHDTM (Musculoskeletal Transplant Foundation).
Although similar in concept and design, each of these biologic meshes is produced in a distinct, proprietary fashion, and different techniques are used by each company in the processing and storage of their respective products.
Given that these processing steps are protected industrial intellectual property, rigorous comparison of the performance of each mesh is very difficult.
It is expected that certain methods, such as employing or avoiding chemical cross-linking of the ECM proteins, would lead to significant differences in cell migration into, and biochemical remodeling of each individual mesh.
These differences may be of particular importance in the scenario of laparoscopic ventral hernia repair, where the mesh is placed in direct apposition to the parietal peritoneum.
In this case, if the biologic were to remodel and take on more of the properties of the distensible peritoneum rather than that of the stronger abdominal wall fascia, this could have a significant impact on the long-term strength and durability of the hernia repair.
A similar situation could also be foreseen to occur at the esophageal hiatus and/or the site of an intestinal stoma.
We feel that it is thus important to study the remodeling processes that these meshes undergo over time and determine if differences in product processing or anatomical position have any effect on mesh incorporation and hernia integrity.
Many of these meshes have already been used in human subjects, yet a certain number of these patients are known have suffered hernia recurrences requiring reoperation and removal of some or all of the original mesh prostheses.
It is our belief that these biologic explants represent an excellent source of material to study the remodeling process over numerous given time points and at various anatomic locations.
We feel it is also important to compare the explanted biologic meshes to "control" tissues, to examine how successfully the biologic meshes are mimicking native tissue at the molecular and histologic level.
To eliminate confounding factors, explanted meshes will be compared to biopsies of abdominal wall fascia from patients undergoing non-hernia related surgical procedures.
Studietype
Observasjonsmessig
Registrering (Faktiske)
241
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients will be selected from the practices of the surgeons listed on the investigational team.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- For those subjects meeting the inclusion criteria, the only population that will be excluded is that of prisoners.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Brent D Matthews, MD, Washington University School of Medicine
- Studieleder: Corey Deeken, PhD, Washington University School of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2007
Primær fullføring (Faktiske)
1. januar 2017
Studiet fullført (Faktiske)
1. januar 2017
Datoer for studieregistrering
Først innsendt
28. januar 2010
Først innsendt som oppfylte QC-kriteriene
28. januar 2010
Først lagt ut (Anslag)
1. februar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201101959
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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