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

NCT06910189 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-24-1100
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Wound

Keywords

Fish Skin Graft (FSG); Kerecis

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  from time of admission to time of discharge (about 3 days from date of surgery)

Secondary Outcomes (11)

• Number of participants that have recurrent surgical site infection

  Upto 1 year after surgery

• Number of participants that require reoperation

  Upto 1 year after surgery

• Time to total wound healing

  From end of surgery to upto 1 year after surgery

• Number of participants that need skin graft

  Upto 1 year after surgery

• time from original surgery with placement of wound vac until the patient gets a skin graft

  upto 1 year after surgery

Study Arms (2)

Fish Skin Graft arm and Vacuum-Assisted Closure

EXPERIMENTAL

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

Vacuum-Assisted Closure only

ACTIVE COMPARATOR

Device: Wound Vacuum-Assisted Closure (VAC)

Interventions

Fish Skin Graft (FSG) DEVICE

FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement

Fish Skin Graft arm and Vacuum-Assisted Closure

Wound Vacuum-Assisted Closure (VAC) DEVICE

Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.

Fish Skin Graft arm and Vacuum-Assisted Closure; Vacuum-Assisted Closure only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jonah Stulberg, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonah Stulberg, MD

CONTACT

(713) 566-5098; Jonah.J.Stulberg@uth.tmc.edu

Debbie Lew

CONTACT

713-566-5097; Debbie.F.Lew@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients and nursing staff will be blinded to the patient's study arm. The operative physician will not be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 4, 2025
• Study Start: April 15, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)