Ventral HerniaNCT03222102
Ventral Hernia Prevention After Liver Transplantation
A study testing Phasix mesh in people with Ventral Hernia and Liver Transplantation, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Liver Transplantation
- What is being tested?
- Phasix mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- 30 Nov 2017to 4 Nov 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
- Age >18 years
- First transplantation
- Signed Informed Consent
Who cannot join
- Combined transplantation
- Revisions after liver transplantation
- Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
- Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
- Pregnant/lactating women
- Known allergies to tetracycline hydrochloride and kanamycin sulfate
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz; Klin. Abteilung für Transplantationschirurgie
Graz, 8036
About this study
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
Read the detailed description
Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.
PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
- Conditions
- Ventral Hernia, Liver Transplantation
- Being tested
- Phasix mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phasix meshDevice
After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.
| Study group | Role | What they receive |
|---|---|---|
| Phasix mesh | Experimental | Phasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation. Receives: Device: Phasix mesh |
| Standard surgery | No intervention | Surgery will be performed according to routine, without the use of Phasix mesh. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventral hernia
Evaluated by ultra-sound imaging
Measured: 12 months after liver transplantation
Secondary outcomes (4)
Infections
Number of infections in the wound area, assessed by clinical evaluation
Measured: 12 months after liver transplantation
Wound healing disorders
Presence of wound healing disorders in the wound area, assessed by clinical evaluation
Measured: 12 months after liver transplantation
Seroma
Presence of seroma in the wound area, assessed by clinical evaluation
Measured: 12 months after liver transplantation
Hematoma
Number of hematoma in the wound area, assessed by clinical evaluation
Measured: 12 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start30 Nov 2017
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
Why it stopped: Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222102
- Sponsor's protocol ID
- Ventral hernia prevention
- Status last verified
- Jan 2025
- First submitted
- 17 Jul 2017
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventral Hernia Prevention After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03222102
- Acronym / sponsor ID
- Ventral hernia prevention
- Conditions
- Ventral Hernia, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 19 Jul 2017 (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.
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
Detailed description
Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.
This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.
PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.
Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.
Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phasix mesh | Experimental | Device: Phasix meshPhasix mesh will be affixed to the exposed fascia after closure of the Abdomen in the course of liver transplantation. |
| Standard surgery | No intervention | –Surgery will be performed according to routine, without the use of Phasix mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- First transplantation
- Signed Informed Consent
Key exclusion criteria (6 listed)
- Combined transplantation
- Revisions after liver transplantation
- Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
- Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
- Pregnant/lactating women
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 |
|---|---|---|
| Phasix meshAfter the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia. | Device | Phasix mesh |
Primary outcome
Incidence of ventral hernia
Time frame: 12 months after liver transplantation
Evaluated by ultra-sound imaging
4 secondary outcomes
Infections
Time frame: 12 months after liver transplantation
Wound healing disorders
Time frame: 12 months after liver transplantation
Seroma
Time frame: 12 months after liver transplantation
Hematoma
Time frame: 12 months after liver transplantation
Results and safety
The study was stopped early (reason given: Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phasix mesh in people with Ventral Hernia and Liver Transplantation, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Jan 2025. 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 Austria. 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?
The study was stopped early (reason given: Due to the changed standard regarding access for liver transplantation, this no longer complied with the requirements of the study protocol.). 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?
Incidence of ventral hernia (time frame: 12 months after liver transplantation). 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 27 Jan 2025.