Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Surgical Wound

Treatments: Device: Wound Vacuum-Assisted Closure (VAC); Device: Fish Skin Graft (FSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06910189

HSC-MS-24-1100

Details and patient eligibility

About

The purpose of this study is to estimate the effect of FSG (Kerecis) on hospital length of stay among adult patients with surgical wounds of at least 40cm2 requiring surgical debridement

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has wound greater than or equal to 40cm2 requiring surgical debridement
• Agreeable to follow up period of up to 1 year

Exclusion criteria

• Patients with wounds that do not require surgical debridement.
• Patients with a known allergy or other sensitivity to fish material
• Patients who are deemed unlikely to follow up (e.g., patients who live out of state).
• Patients in police custody/incarcerated.
• Patients unable to communicate in either Spanish or English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

96 participants in 2 patient groups

Fish Skin Graft arm and Vacuum-Assisted Closure

Experimental group

Treatment:

Device: Fish Skin Graft (FSG)

Device: Wound Vacuum-Assisted Closure (VAC)

Vacuum-Assisted Closure only

Active Comparator group

Treatment:

Device: Wound Vacuum-Assisted Closure (VAC)