Incisional HerniaPhase 4PROPHYBIOMNCT02277262
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
A Phase 4 study testing Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention and Direct suture of the anterior abdominal wall fascia in people with Incisional Hernia, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
Trial summary
To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention and Direct suture of the anterior abdominal wall fascia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Oct 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients aged > 18 years old
- Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin (peritoneal reactivity, positive Blumberg sign, fever, free air/fluid in abdominal cavity, leucocytosis, increased CRP (C-reactive protein, lactic dehydrogenase (LDH), tachycardia, tachypnea, clinical or radiological evidence/suspect of bowel ischemia)
- Eventual strong suspect of possible bacterial translocation (reduction of the natural intestinal barrier against bacterial translocation, i.e. bowel ischemia, bowel overdistension, intestinal occlusion, etc.)
- Surgical indication for midline laparotomy independently from eventual previous laparotomies
- Informed consent
Who cannot join
- • Patients aged < 18 years old
- Informed consent refusal
- No Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin.
- Surgical indication for laparotomies other than midline one
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Papa Giovanni XXIII hospital
Bergamo, 24128
Federico Coccolini, MD, 0039-0352673412, federico.coccolini@gmail.com
Luca Ansaloni, MD, 0039-0352673483, lansaloni@hpg23.it
About this study
To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
- Conditions
- Incisional Hernia
- Being tested
- Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention, Direct suture of the anterior abdominal wall fascia
- Keywords
- peritonitis patients
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological swine dermis not cross-linked prosthesis positioning in incisional hernia preventionDevice
Also called Biological swine dermis not-cross-linked prosthesis positioning
The mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
Direct suture of the anterior abdominal wall fasciaProcedure or surgery
Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed reinforcing the suture with a swine dermis biological prosthesis positioned sublay Receives: Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention |
| Control arm | Active comparator | Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed by emi-continuous monofilament sutures with an intermediate-reabsorbable-time suture Receives: Procedure: Direct suture of the anterior abdominal wall fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia rate
Measured: 3 months
Incisional hernia rate
Measured: 6 months
Incisional hernia rate
Measured: 12 months
Incisional hernia rate
Measured: 24 months
Secondary outcomes (13)
Morbidity
Measured: 0 months
Morbidity
Measured: 3 months
Morbidity
Measured: 6 months
Morbidity
Measured: 12 months
Morbidity
Measured: 24 months
Length of surgery
Measured: Day 0
Time to drain removal
Measured: participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
Length of stay in hospital
Measured: At the discharge, an expected average of 1-2 weeks after the intervention
Mortality
Measured: 0 months
Mortality
Measured: 3 months
Mortality
Measured: 6 months
Mortality
Measured: 12 months
Mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Coccolini, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277262
- Sponsor's protocol ID
- 154-14
- Acronym
- PROPHYBIOM
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
- ClinicalTrials.gov ID
- NCT02277262
- Acronym / sponsor ID
- PROPHYBIOM / 154-14
- Conditions
- Incisional Hernia
- Keywords
- peritonitis patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 28 Oct 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.
To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Biological swine dermis not cross-linked prosthesis positioning in incisional hernia preventionPatients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed reinforcing the suture with a swine dermis biological prosthesis positioned sublay |
| Control arm | Active comparator | Procedure: Direct suture of the anterior abdominal wall fasciaPatients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed by emi-continuous monofilament sutures with an intermediate-reabsorbable-time suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients aged > 18 years old
Key exclusion criteria (5 listed)
- • Patients aged < 18 years old
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 |
|---|---|---|
| Biological swine dermis not cross-linked prosthesis positioning in incisional hernia preventionAlso: Biological swine dermis not-cross-linked prosthesis positioningThe mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane. | Device | Treatment arm |
| Direct suture of the anterior abdominal wall fasciaAnterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane. | Procedure or surgery | Control arm |
Primary outcome
Incisional hernia rate
Time frame: 3 months
Incisional hernia rate
Time frame: 6 months
Incisional hernia rate
Time frame: 12 months
Incisional hernia rate
Time frame: 24 months
13 secondary outcomes
Morbidity
Time frame: 0 months
Morbidity
Time frame: 3 months
Morbidity
Time frame: 6 months
Morbidity
Time frame: 12 months
Morbidity
Time frame: 24 months
Length of surgery
Time frame: Day 0
Time to drain removal
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
Length of stay in hospital
Time frame: At the discharge, an expected average of 1-2 weeks after the intervention
Mortality
Time frame: 0 months
Mortality
Time frame: 3 months
Mortality
Time frame: 6 months
Mortality
Time frame: 12 months
Mortality
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention and Direct suture of the anterior abdominal wall fascia in people with Incisional Hernia, run by A.O. Ospedale Papa Giovanni XXIII 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 5 inclusion and 5 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 28 Oct 2014. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia rate (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2014.