HerniaPhase 1/236PNCT02137018
"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
A Phase 1/2 study testing PPL fixation by BP and PPL mesh in people with Hernia and Incisional Hernia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic… Read more about this study
- Who is it for?
- Ages 3 to 6 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hernia, Incisional Hernia
- What is being tested?
- PPL fixation by BP and PPL mesh
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- animal model: lantrace female pigs of 20 kg of body weight
Who cannot join
- any kind of illness in porcine subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Nanotechnologies Applied to General Surgery and Emergency Surgery: The Buckypaper as a New Fixing Method for Prosthetic Materials in the Treatment of Abdominal Wall Hernias, Diaphragmatic Hernias, Diaphragmatic Rupture, Incisional Hernia and Abdominal Wall Disaster in Laparotomy Procedure and Laparoscopic Procedures".
"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.
- Conditions
- Hernia, Incisional Hernia
- Being tested
- PPL fixation by BP, PPL mesh
- Keywords
- hernia, incisional hernia, device, pig
- Medical subject headings
- Hernia, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPL fixation by BPDevice
Also called PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998), The BP (NanoLab Inc, Newton, MA 02458 USA)
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 meshDevice
Also called PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998)
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.
| Study group | Role | What they receive |
|---|---|---|
| laparotomy with PPL mesh implantation | Active comparator | control group: laparotomy with PPL mesh implantation (traditional method) Receives: Device: PPL mesh |
| laparotomy with PPL fixation by BP | Experimental | laparotomic surgery with PPL mesh fixation by BP (new fixing method) Receives: Device: PPL fixation by BP |
| laparoscopy with PPL mesh implantation | Active comparator | control group: laparoscopy with PPL mesh implantation (traditional method) Receives: Device: PPL mesh |
| laparoscopy with PPL fixation by BP | Experimental | laparoscopic surgery with PPL mesh fixation by BP (new fixing method) Receives: Device: PPL fixation by BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of durability without side effects of surgical device
We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model
Measured: up to 36 months
Secondary outcomes (1)
time required to position the device during surgery
time required to position the device during surgery (time is related with probability of side effect during surgery)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Martinelli, Andrea, M.D., GA Carru, AM Chiaretti, F Faiola, G Ceccarelli, AI Chiaretti, P Consentino, E Valente
- Responsible party
- Principal investigator, Massimo Chiaretti, University of Roma La Sapienza
- Investigators
- Massimo Chiaretti, MD, PhD, MSc, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137018
- Sponsor's protocol ID
- 36Pa
- Acronym
- 36P
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23635074Bellucci 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.
PubMed 20148633Bellucci 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.
PubMed 19572819Di 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.
PubMed 19063954
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Nanotechnologies Applied to General Surgery and Emergency Surgery: The Buckypaper as a New Fixing Method for Prosthetic Materials in the Treatment of Abdominal Wall Hernias, Diaphragmatic Hernias, Diaphragmatic Rupture, Incisional Hernia and Abdominal Wall Disaster in Laparotomy Procedure and Laparoscopic Procedures".
- ClinicalTrials.gov ID
- NCT02137018
- Acronym / sponsor ID
- 36P / 36Pa
- Conditions
- Hernia, Incisional Hernia
- Keywords
- hernia, incisional hernia, device, pig
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Martinelli, Andrea, M.D., GA Carru, AM Chiaretti, F Faiola, G Ceccarelli, AI Chiaretti, P Consentino, E Valente
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| laparotomy with PPL mesh implantation | Active comparator | Device: PPL meshcontrol group: laparotomy with PPL mesh implantation (traditional method) |
| laparotomy with PPL fixation by BP | Experimental | Device: PPL fixation by BPlaparotomic surgery with PPL mesh fixation by BP (new fixing method) |
| laparoscopy with PPL mesh implantation | Active comparator | Device: PPL meshcontrol group: laparoscopy with PPL mesh implantation (traditional method) |
| laparoscopy with PPL fixation by BP | Experimental | Device: PPL fixation by BPlaparoscopic surgery with PPL mesh fixation by BP (new fixing method) |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- animal model: lantrace female pigs of 20 kg of body weight
Key exclusion criteria (1 listed)
- any kind of illness in porcine subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPL fixation by BPAlso: PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998), The BP (NanoLab Inc, Newton, MA 02458 USA)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. | Device | laparoscopy with PPL fixation by BP, laparotomy with PPL fixation by BP |
| PPL meshAlso: PPL Premilene mesh B Braun (ref. 1064435, lot. 112313), PPL Parietene mesh Tyco (ref. PP3030, lot. SIK00587), V-Loc 180 (ref. VLOCL0024, lot. A1D0998)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. | Device | laparoscopy with PPL mesh implantation, laparotomy with PPL mesh implantation |
Primary outcome
Time of durability without side effects of surgical device
Time frame: up to 36 months
We are testing the time (months/year) of durability without side effects of a new fixing method for prosthetic materials for abdominal wall hernias and wall defects repairing on pig model
1 secondary outcome
time required to position the device during surgery
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Background: PubMed 23635074Martinelli 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.
- Background: PubMed 20148633Bellucci 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.
- Background: PubMed 19572819Bellucci 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.
- Background: PubMed 19063954Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Chiaretti, MD, PhD, MSc principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PPL fixation by BP and PPL mesh in people with Hernia and Incisional Hernia, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of durability without side effects of surgical device (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137018, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.