Kerecis Fish Skin for Anal Fistula
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Kerecis fish skin (known as Kerecis SurgiClose) as a new treatment for healing anal fistulas and chronic wounds that resist closure. The researchers aim to evaluate the effectiveness of this fish skin in the healing process. This trial may suit adults with a persistent anal fistula (an abnormal connection near the anus) who can consent to participate. As an unphased trial, it offers a unique opportunity to explore innovative healing options for challenging wounds.
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 Kerecis fish skin is safe for healing anal fistulas?
Research has shown that Kerecis SurgiClose, made from fish skin, helps heal difficult wounds, including anal fistulas. Anal fistulas are small tunnels that can form between the end of the bowel and the skin near the anus. Studies indicate that patients generally accept fish skin grafts well, with no major safety issues reported. Most people do not experience serious side effects with this treatment. This suggests that Kerecis SurgiClose could be a safe option for treating anal fistulas.12345
Why are researchers excited about this trial?
Unlike traditional treatments for anal fistulas, which often involve surgical procedures or setons to promote drainage, Kerecis SurgiClose uses intact fish skin to encourage healing. This fish skin is rich in omega-3 fatty acids, providing a natural scaffold for tissue regeneration. Researchers are excited because this method could offer a less invasive option that supports faster and more complete healing of chronic wounds. Plus, the fish skin's unique properties might reduce infection risks and improve patient comfort compared to conventional methods.
What evidence suggests that Kerecis SurgiClose might be an effective treatment for anal fistula?
Research has shown that Kerecis SurgiClose, made from fish skin, may aid in healing complex wounds. This product mimics human skin, supporting the body's natural healing process. Studies have demonstrated its effectiveness for various hard-to-heal wounds. Although specific data on anal fistulas is limited, the fish skin's success with other wounds is promising. In this trial, participants will receive the Kerecis SurgiClose treatment to evaluate its effectiveness in healing cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds. It is believed to help close wounds by providing a structure for new tissue growth.12345
Who Is on the Research Team?
Nicholas P. McKenna, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with an anal fistula and associated non-healing draining wounds. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated non-healing draining wounds
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kerecis SurgiClose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor