"Nanotechnologies Applied to General Surgery and Emergency Surgery: Buckypaper as a New Fixing Method for Prosthetic Materials for the Treatment of Hernia and Incisional Hernia in Laparotomy and Laparoscopic
NCT ID: NCT02137018
Last Updated: 2015-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2013-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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laparotomy with PPL mesh implantation
control group: laparotomy with PPL mesh implantation (traditional method)
PPL mesh
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.
laparotomy with PPL fixation by BP
laparotomic surgery with PPL mesh fixation by BP (new fixing method)
PPL fixation by BP
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.
laparoscopy with PPL mesh implantation
control group: laparoscopy with PPL mesh implantation (traditional method)
PPL mesh
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.
laparoscopy with PPL fixation by BP
laparoscopic surgery with PPL mesh fixation by BP (new fixing method)
PPL fixation by BP
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.
Interventions
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PPL fixation by BP
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.
PPL mesh
A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
6 Months
FEMALE
Yes
Sponsors
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Martinelli, Andrea, M.D.
INDIV
GA Carru
UNKNOWN
AM Chiaretti
UNKNOWN
F Faiola
UNKNOWN
G Ceccarelli
UNKNOWN
AI Chiaretti
UNKNOWN
P Consentino
UNKNOWN
E Valente
UNKNOWN
University of Roma La Sapienza
OTHER
Responsible Party
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Massimo Chiaretti
Researcher
Principal Investigators
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Massimo Chiaretti, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Roma La Sapienza
Locations
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Animal House Agostino Gemelli University of Rome.
Rome, RM, Italy
Countries
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References
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Martinelli A, Carru GA, D'Ilario L, Caprioli F, Chiaretti M, Crisante F, Francolini I, Piozzi A. Wet adhesion of buckypaper produced from oxidized multiwalled carbon nanotubes on soft animal tissue. ACS Appl Mater Interfaces. 2013 May 22;5(10):4340-9. doi: 10.1021/am400543s. Epub 2013 May 1.
Bellucci S, Chiaretti M, Onorato P, Rossella F, Grandi MS, Galinetto P, Sacco I, Micciulla F. Micro-Raman study of the role of sterilization on carbon nanotubes for biomedical applications. Nanomedicine (Lond). 2010 Feb;5(2):209-15. doi: 10.2217/nnm.09.100.
Bellucci S, Chiaretti M, Cucina A, Carru GA, Chiaretti AI. Multiwalled carbon nanotube buckypaper: toxicology and biological effects in vitro and in vivo. Nanomedicine (Lond). 2009 Jul;4(5):531-40. doi: 10.2217/nnm.09.36.
Di Sotto A, Chiaretti M, Carru GA, Bellucci S, Mazzanti G. Multi-walled carbon nanotubes: Lack of mutagenic activity in the bacterial reverse mutation assay. Toxicol Lett. 2009 Feb 10;184(3):192-7. doi: 10.1016/j.toxlet.2008.11.007. Epub 2008 Nov 21.
Other Identifiers
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36Pa
Identifier Type: -
Identifier Source: org_study_id
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