Incisional HerniaNCT04681326
Prophylactic Implantation of Biologic Mesh in Peritonitis
A study testing biological prosthesis in people with Incisional Hernia and Peritonitis, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial summary
Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis the risk of incisional hernia (IH) is extremely elevated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Peritonitis
- What is being tested?
- biological prosthesis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- 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 C-Reactive Protein (CRP), 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
Azienda Ospedaliera-Universitaria di Parma
Parma, 43125
Fausto Catena, 0521702163, fcatena@ao.pr.it
About this study
Official title: PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis: a Prospective Multicentric Randomized Controlled Trial
Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis the risk of incisional hernia (IH) is extremely elevated. The incidence of IH in patients operated with peritonitis is up to 54 %, compared with an incidence of 11-26 % in the general surgical population. Moreover, up to 24.1 % of patients with peritonitis undergoing emergency laparotomy may develop fascial dehiscence. The evaluation of quality of life of patients with IH showed lower mean scores on physical components of health-related quality of life and body image. The prophylactic mesh implantation demonstrated to reduce the incisional hernia rate in patients undergoing vascular or bariatric procedures. However, the intraperitoneal non absorbable mesh implantation in infected fields is generally considered at least of doubtful safety because of the theoretical increased risk of chronic mesh infection and enterocutaneous fistula. Most incisional hernias develop during the first three months after surgery, which represents the critical period for the healing of transected muscular and fibrous layers of the abdominal wall. However, most studies recommended a long-term follow up period of up to at least 5 years for midline abdominal incisions to determine the real incisional hernia rate. The midline abdominal incision is preferred in abdominal surgery, as it provides wide and rapid access compared other incisions. However, the incidence of incisional hernias is higher following midline abdominal incisions than in other abdominal incisions. In emergency surgery the midline incision in the majority of cases is a necessity. Several factors affect the process of wound healing: surgical site infection, poor surgical technique, and patient-related factors (i.e. peritonitis, old age, obesity, diabetes mellitus, nutritional deficiencies, hepatic cirrhosis, jaundice, renal impairment, malignancy, cardiac disease, chest problems, previous abdominal incisions, steroid therapy). Data about the use of biological prosthesis in infected fields are scarce and derive principally from case reports and case series. However, indications about their use and usefulness in infected fields have been recently published by the Italian Biological Prosthesis Working Group (IBPWG). A previously published prospective observational study evaluated the efficacy of implantation of biological prosthesis in high risk patients in order to reduce the incidence of incisional hernia. This study suggested the efficacy of this kind of prosthesis in reducing incisional hernia rate in patients with multiple risk factors. A recently published meta-analysis showed as the use of biological prosthesis in ventral hernia repair resulted in a lower infectious wound complication rate but in an similar recurrence rate. These results supports the application of biological prosthesis in high risk patients. One recent systematic review evaluated the positive effect on incisional hernia rate of the prophylactic mesh positioning in high risk patients. No randomized trials have been published since now about the use of biological prosthesis in contaminated or infected fields. The rationale of the trial is 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, Peritonitis
- Being tested
- biological prosthesis
- Medical subject headings
- Incisional Hernia, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological prosthesisDevice
retro-muscular positioning of a swine dermal collagen prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Biological prosthesis | Experimental | The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia to allow the positioning of the transfix stitches necessary to the mesh fixation. Successively the retro-muscular rectum muscles plane will be prepared by the separation of the rectum muscles from the posterior rectum-muscles fascia. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched placed at the cardinal and inter-cardinal points. The prosthesis will be placed with a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt (JP) 10 suction drain will be placed under the prosthesis. A JP 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 JP 10 suction drain will be placed over the anterior fascia. No subcutaneous suture. Skin stapler or interrupted stitches will be used to close. Receives: Device: biological prosthesis |
| Standard of care | No intervention | Normal abdominal wall closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with incisional hernia
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
Measured: 3 months post surgery
Number of participants with incisional hernia
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
Measured: 6 months post surgery
Number of participants with incisional hernia
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
Measured: 12 months post surgery
Secondary outcomes (3)
Incidence of adverse events after surgery for peritonitis
Number of patients with adverse events (prosthesis rejection, infection, seroma), after pre-peritoneal positioning of the swine dermal collagen prosthesis as prophylaxis for incisional hernia in peritonitis patients
Measured: 3 months post surgery
Incidence of adverse events after surgery for peritonitis
Number of patients with adverse events (prosthesis rejection, infection, seroma), after pre-peritoneal positioning of the swine dermal collagen prosthesis as prophylaxis for incisional hernia in peritonitis patients
Measured: 6 months post surgery
Incidence of adverse events after surgery for peritonitis
Number of patients with adverse events (prosthesis rejection, infection, seroma), after pre-peritoneal positioning of the swine dermal collagen prosthesis as prophylaxis for incisional hernia in peritonitis patients
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fausto Catena, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681326
- Sponsor's protocol ID
- 506/2019/DISP/AOUPR
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study result will be used for oral presentation, publications and seminars. The personal patient's data will be not share for privacy.
Publications
Coccolini F, Tarasconi A, Petracca GL, Perrone G, Giuffrida M, Disisto C, Sartelli M, Carcoforo P, Ansaloni L, Catena F. PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial. Trials. 2022 Mar 4;23(1):198. doi: 10.1186/s13063-022-06103-4.
PubMed 35246206
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis: a Prospective Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04681326
- Acronym / sponsor ID
- 506/2019/DISP/AOUPR
- Conditions
- Incisional Hernia, Peritonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Dec 2020 (actual)
- 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.
Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis the risk of incisional hernia (IH) is extremely elevated. The incidence of IH in patients operated with peritonitis is up to 54 %, compared with an incidence of 11-26 % in the general surgical population. Moreover, up to 24.1 % of patients with peritonitis undergoing emergency laparotomy may develop fascial dehiscence. The evaluation of quality of life of patients with IH showed lower mean scores on physical components of health-related quality of life and body image. The prophylactic mesh implantation demonstrated to reduce the incisional hernia rate in patients undergoing vascular or bariatric procedures. However, the intraperitoneal non absorbable mesh implantation in infected fields is generally considered at least of doubtful safety because of the theoretical increased risk of chronic mesh infection and enterocutaneous fistula. Most incisional hernias develop during the first three months after surgery, which represents the critical period for the healing of transected muscular and fibrous layers of the abdominal wall. However, most studies recommended a long-term follow up period of up to at least 5 years for midline abdominal incisions to determine the real incisional hernia rate. The midline abdominal incision is preferred in abdominal surgery, as it provides wide and rapid access compared other incisions. However, the incidence of incisional hernias is higher following midline abdominal incisions than in other abdominal incisions. In emergency surgery the midline incision in the majority of cases is a necessity. Several factors affect the process of wound healing: surgical site infection, poor surgical technique, and patient-related factors (i.e. peritonitis, old age, obesity, diabetes mellitus, nutritional deficiencies, hepatic cirrhosis, jaundice, renal impairment, malignancy, cardiac disease, chest problems, previous abdominal incisions, steroid therapy). Data about the use of biological prosthesis in infected fields are scarce and derive principally from case reports and case series. However, indications about their use and usefulness in infected fields have been recently published by the Italian Biological Prosthesis Working Group (IBPWG). A previously published prospective observational study evaluated the efficacy of implantation of biological prosthesis in high risk patients in order to reduce the incidence of incisional hernia. This study suggested the efficacy of this kind of prosthesis in reducing incisional hernia rate in patients with multiple risk factors. A recently published meta-analysis showed as the use of biological prosthesis in ventral hernia repair resulted in a lower infectious wound complication rate but in an similar recurrence rate. These results supports the application of biological prosthesis in high risk patients. One recent systematic review evaluated the positive effect on incisional hernia rate of the prophylactic mesh positioning in high risk patients. No randomized trials have been published since now about the use of biological prosthesis in contaminated or infected fields. The rationale of the trial is 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological prosthesis | Experimental | Device: biological prosthesisThe subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia to allow the positioning of the transfix stitches necessary to the mesh fixation. Successively the retro-muscular rectum muscles plane will be prepared by the separation of the rectum muscles from the posterior rectum-muscles fascia. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched placed at the cardinal and inter-cardinal points. The prosthesis will be placed with a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt (JP) 10 suction drain will be placed under the prosthesis. A JP 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 JP 10 suction drain will be placed over the anterior fascia. No subcutaneous suture. Skin stapler or interrupted stitches will be used to close. |
| Standard of care | No intervention | –Normal abdominal wall closure |
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
- 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 C-Reactive Protein (CRP), 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
Key exclusion criteria (5 listed)
- 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.
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 prosthesisretro-muscular positioning of a swine dermal collagen prosthesis | Device | Biological prosthesis |
Primary outcome
Number of participants with incisional hernia
Time frame: 3 months post surgery
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
Number of participants with incisional hernia
Time frame: 6 months post surgery
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
Number of participants with incisional hernia
Time frame: 12 months post surgery
Comparison between number of patients with incisional hernia after surgery in the two arms of the study
3 secondary outcomes
Incidence of adverse events after surgery for peritonitis
Time frame: 3 months post surgery
Incidence of adverse events after surgery for peritonitis
Time frame: 6 months post surgery
Incidence of adverse events after surgery for peritonitis
Time frame: 12 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 35246206Coccolini F, Tarasconi A, Petracca GL, Perrone G, Giuffrida M, Disisto C, Sartelli M, Carcoforo P, Ansaloni L, Catena F. PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial. Trials. 2022 Mar 4;23(1):198. doi: 10.1186/s13063-022-06103-4.
- Individual participant dataSharing planned: No. The study result will be used for oral presentation, publications and seminars. The personal patient's data will be not share for privacy.
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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 study testing biological prosthesis in people with Incisional Hernia and Peritonitis, run by Azienda Ospedaliero-Universitaria di Parma 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 23 Dec 2020. 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.
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?
Number of participants with incisional hernia (time frame: 3 months post surgery). The study lists 3 primary outcomes in all. 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 NCT04681326, which also lists 1 linked publication.
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 23 Dec 2020.