Biologic Mesh for Preventing Hernia in Bladder Cancer

Overseen By Ileana Aldana

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Previous scar, Survival < 12 months, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a biologic mesh (acellular cadaveric dermal matrix) can help prevent parastomal hernias, which are bulges that can form around the site where a new urine passage (called an ileal conduit) is placed during bladder removal surgery for cancer. The study compares two groups: one receiving the biologic mesh and one following standard procedures without the mesh. It seeks participants who have bladder cancer and are scheduled for surgery to remove their bladder and create an ileal conduit. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biologic mesh is safe for preventing parastomal hernia?

Research has shown that using acellular cadaveric dermal matrix (a skin-like material from donors) in surgeries is generally safe. In one study, patients experienced low complication rates: 5.1% had skin infections, 5.9% had implant failures, and 8.1% had wound infections. Another report found no serious problems directly linked to the mesh itself. Overall, this treatment is well-tolerated with manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Biologic mesh is unique because it uses an acellular cadaveric dermal matrix to reinforce the abdominal wall during bladder cancer surgery, specifically during radical cystectomy. Unlike traditional methods that leave the area without added support, this biologic mesh acts like a scaffold to support tissue regeneration and reduce the risk of hernia formation. Researchers are excited about this approach because it has the potential to improve recovery outcomes and lower complications compared to the standard practice, which involves no additional intervention beyond the surgery itself.

What evidence suggests that biologic mesh is effective for preventing parastomal hernia in bladder cancer patients?

In this trial, participants in Arm I will receive biologic mesh, made from processed human skin, during radical cystectomy to help reduce hernia recurrence. Research has shown that in studies on rebuilding the abdominal wall, hernia recurrence rates were 11.5% after three years and 14.6% after five years, indicating that the mesh provides a strong and lasting repair. Although some issues like fluid buildup and wound infections have been reported, they occur infrequently. Overall, biologic mesh appears promising for preventing hernias, especially in complex surgeries, such as those for bladder cancer treatment. Participants in Arm II will undergo standard of care radical cystectomy without the use of biologic mesh. ^{1 2 3 4 6}

Who Is on the Research Team?

Hooman Djaladat

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for bladder cancer patients who are having their bladders removed and an ileal conduit created. Participants must understand the study and agree to sign a consent form. They should be able to follow up at USC or centers that can share clinical data. Those with previous scars, short life expectancy, or allergies to similar biologic materials cannot join.

Inclusion Criteria

I am having my bladder removed and will have a urinary diversion.

Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

My survival after surgery is expected to be less than 12 months.

You have had allergic reactions to substances similar to the cadaveric component in Flex HD.

You have had a previous surgery in the area where the ileal conduit is located.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo radical cystectomy and placement of the ileal conduit, with or without biologic mesh

Surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for the development of parastomal hernia and mesh-related complications

Up to 2 years

Every 2-4 months

What Are the Treatments Tested in This Trial?

Interventions

• Acellular Cadaveric Dermal Matrix

Trial Overview The PUBMIC trial is testing if using a biologic mesh can prevent parastomal hernias in patients undergoing bladder removal and ileal conduit diversion. It's a phase III study where participants are randomly chosen to receive either the biologic mesh or not during surgery.

How Is the Trial Designed?

Group I: Arm I (biologic mesh) Experimental Treatment 1 Intervention

Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.

Group II: Arm II (no intervention) Active Control 1 Intervention

Patients undergo standard of care radical cystectomy and placement of the ileal conduit.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Musculoskeletal Transplant Foundation

Collaborator

Trials

22

Recruited

1,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33086319/

A Study of Patients with Over 60 Months of Follow-up Despite its use in complex AWR, ADM provides durable long-term outcomes with relatively low recurrence rates.

2. publichealth.llu.edu publichealth.llu.edu/sites/publichealth.llu.edu/files/docs/a-meta-analysis-of-outcomes-using-acellular-dermal-matrix-in.pdf

a-meta-analysis-of-outcomes-using-acellular-dermal- ... The overall risks and complications were as follows: cellulitis, 5.1%; implant failure, 5.9%; seroma formation, 8%; wound dehiscence, 8.1%; wound infection, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27993696/

Long-Term Outcomes after Abdominal Wall Reconstruction ... Conclusions: Use of ADM for AWR was associated with 11.5% and 14.6% hernia recurrence rates at 3- and 5-years follow-up, respectively. Avoiding bridged repairs ...

4. researchgate.net researchgate.net/publication/346450904_Acellular_Dermal_Matrix_Provides_Durable_Long-Term_Outcomes_in_Abdominal_Wall_Reconstruction_A_Study_of_Patients_with_Over_60_Months_of_Follow-up

Acellular Dermal Matrix Provides Durable Long-Term ... ... A randomized trial of 253 patients showed that synthetic mesh significantly reduced the risk of hernia recurrence compared with biologic ...

5. cda-amc.ca cda-amc.ca/sites/default/files/pdf/K0263_Biologic_Mesh_htis-1-5.pdf

Biological Mesh: Clinical Effectiveness, Cost- ... acellular dermal matrix in prevention of Frey's syndrome after parotidectomy. Br J Oral. Maxillofac Surg. 2008 Dec;46(8):649-52. PubMed: PM18547692. 92 ...

6. auanews.net auanews.net/issues/articles/2023/august-extra-2023/aua2023-best-posters-prophylactic-use-of-biologic-mesh-in-ileal-conduit-initial-report-of-a-randomized-controlled-trial

AUA2023 BEST POSTERS Prophylactic Use of Biologic ... No definite mesh-related adverse events were reported. Five cases (3 in mesh and 2 in control arms) were required surgical PSH repair. On ...