Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phasix™ Mesh.
- Who it may be relevant to
- Registry conditions: Open Midline Laparotomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, France, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Overview
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Detailed description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Interventions
- Device Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Primary outcome measures
- Rate of Incisional Hernia [Time frame: 24-Months]
Secondary outcome measures (7)
- Rate of Incisional Hernia [Time frame: 60-Months]
- Rate of Device-related Adverse Events (AEs) [Time frame: 60-Months]
- Length of surgical procedure in minutes [Time frame: Study Day 0]
- Length of time for wound closure in minutes [Time frame: Study Day 0]
- Length of hospital stay in days [Time frame: Through hospital stay, typically 3 days]
- Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) [Time frame: 60-Months]
- Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) [Time frame: 60-months]
Eligibility criteria
Inclusion criteria
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
Exclusion criteria
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 24 months
- Pregnant or planning to become pregnant
- Receiving a medication/medical condition that may adversely affect wound healing
- ASA Class > IV
- Enrolled in another clinical trial
- Site personnel directly involved with this trial
- Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions are created
- Prior onlay mesh
- Surgeon is unable to fully close the fascia
- The surgery requires more than a single piece of mesh
- Contraindication to placement of mesh
- CDC Class IV/Active Infection
- Breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 31 centers
- Dignity Health — Phoenix
- Keck Medical Center of USC — Los Angeles
- University of California San Francisco — San Francisco
- Hartford Hospital — Hartford
- St. Francis Hospital and Medical Center — Hartford
- Emory University — Atlanta
- OSF Saint Francis Medical Center — Peoria
- Indiana University — Indianapolis
- … and 23 more centers
France · 7 centers
- CHU de Dijon Bourgogne — Dijon
- Centre Hospitalier Universitaire de Lille — Lille
- Centre Hospitalier Universitaire de Lille — Lille
- Hôpital Paris St Joseph — Paris
- Hôpital Lyon Sud — Pierre-Bénite
- CHU Reims — Reims
- Hopitaux Universitaires de Strasbourg — Strasbourg
Germany · 5 centers
- Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology — Berlin
- Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery — Berlin
- Asklepios Klinik Barmbek — Hamburg
- Universitätsklinikum Heidelberg — Heidelberg
- Bundeswehrzentralkrankenhaus Koblenz — Koblenz
Austria · 1 center
- Krankenhaus der Barmherzigen Brüder Graz — Graz
Belgium · 1 center
- Universitair Ziekenhuis Gent — Ghent
Identifiers
NCT: NCT03911700 · DVL-HE-018