An observational study in Ventral Incisional Hernia, sponsored by University of South Florida. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by University of South Florida · Observational
Among 34 studies in Incisional Hernia with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Incisional Hernia · United States.
Among the 34 studies in Incisional Hernia with a site in United States, this one is the 9th largest by enrollment of the 14 observational ones that give a count, is one of 2 that started in 2019, is one of 14 observational ones, and was the 19th registered.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
Browse Incisional Hernia studies →6 of the 34 studies in Incisional Hernia with a site in United States are open now. Recruiting first, the newest first:
The Cleveland Clinic · Sites in United States
Ages 18+
Clayton Petro · Sites in United States
Ages 18+ · Healthy volunteers
W.L.Gore & Associates · Sites in United States
Ages 18+
Prisma Health-Upstate · Sites in United States
Ages 18+ · Healthy volunteers
University of South Florida · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 38 Incisional Hernia studies recruiting now, 27 (71%) set no upper age limit and 2 (5%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 150 across 75 observational studies indexed under Incisional Hernia.
Median enrollment 98 across the 20 interventional studies, 38 across the 14 observational. Of the 24 that completed or were terminated, 9 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 34 have an industry lead sponsor. The 10 most frequent:
University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
University of South Florida has 3 studies filed under Incisional Hernia — fewer than ten, so there is no comparison to draw.
5 of the studies in Incisional Hernia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT06511414Northwestern UniversityEffect of Duramesh™ on Hernia Formation After Ileostomy Closure | 2026-12-01 |
| NCT07874724University of South FloridaCryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair | 2027-03-01 |
| NCT06306976Prisma Health-UpstateShear-Wave Elastography | 2027-07-31 |
| NCT07871630Corewell Health WestPhasix Mesh Underlay During Loop Ileostomy Closure | 2027-10-30 |
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Among the 34 studies in Incisional Hernia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate.
Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.
Patients requiring open ventral hernia repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mesh for hernia repair: Standard of care products used by the Investigator for open ventral hernia repair procedure
Device: Mesh for hernia repair
Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.
Incidence of ventral hernia recurrence
Time frame: 2 years from study ventral hernia repair
Time to ventral hernia recurrence
Time frame: 2 years from study ventral hernia repair
Incidence of wound complications
Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
Time frame: 90 days from study ventral hernia repair
Incidence of enterocutaneous fistula formation
Time frame: 2 years from study ventral hernia repair
Mean Carolinas Comfort Scale score
Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115
Time frame: 2 years from study ventral hernia repair
Mean Visual Analog Scale score
Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable)
Time frame: 2 years from study ventral hernia repair
Mean mesh deployment time
Defined as the time mesh preparation starts to time mesh placement ends
Time frame: during surgery
Mean procedure time
Defined as time of incision to time of closure
Time frame: during surgery
Mean total cost of hospitalization for primary admission
Defined as cost from surgery to hospital discharge
Time frame: From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of surgery for primary admission
Defined as cost from preoperative preparation to anesthesia discharge
Time frame: during surgery
Mean total cost of narcotic usage for primary admission
Defined as cost from narcotic use from surgery to hospital discharge
Time frame: From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of readmissions
any hospital readmissions related to ventral hernia complications or recurrence
Time frame: 2 years from study ventral hernia repair
Plan to share: No
Ran from Feb 2019 to primary completion in Jun 2021, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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