A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose

Mayo Clinic

Status: Invitation-only

Conditions: Fistula-in-ano; Draining Wound

Treatments: Device: Kerecis fish skin

Study type: Interventional

Funder types: Other

Identifiers

NCT07098715

24-007753

Details and patient eligibility

About

The purpose of this study is to determine feasibility of Kerecis intact fish skin for healing of fistula-in-ano and associated non-healing draining wounds.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults age ≥18 years old
• Cryptoglandular fistula-in-ano (primary or recurrent)
• The ability to give appropriate consent

Exclusion criteria

• Age <18 years old

• Pregnant (as determined by urine test)

• Any known allergies or sensitivities to fish material

• Prisoners

• Inflammatory bowel disease

• Fistula-in-ano associated with:

  • Anal cancer
  • Rectal cancer
  • Extramammary Paget's disease
  • Hidradenitis suppurativa
  • Anal condyloma
  • Active infection / abscess

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intact Kerecis Fish Skin

Experimental group

Description:

To assess shot-term outcomes (rates of healing) using Kerecis intact fish skin to heal cryptoglandular fistula-in-ano and associated chronic non-healing draining wounds.

Treatment:

Device: Kerecis fish skin