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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Wound
• Intervention / Treatment: Device: Fish Skin Graft (FSG); Device: Wound Vacuum-Assisted Closure (VAC)

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonah Stulberg, MD; Phone Number: (713) 566-5098; Email: Jonah.J.Stulberg@uth.tmc.edu
• Study Contact Backup: Name: Debbie Lew; Phone Number: 713-566-5097; Email: Debbie.F.Lew@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Jonah Stulberg, MD; Phone Number: (713) 566-5098; Email: Jonah.J.Stulberg@uth.tmc.edu
      • Contact: Debbie Lew; Phone Number: 713-566-5097; Email: Debbie.F.Lew@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish Skin Graft arm and Vacuum-Assisted Closure	Device: Fish Skin Graft (FSG); FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement; Device: Wound Vacuum-Assisted Closure (VAC); Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.
Active Comparator: Vacuum-Assisted Closure only	Device: Wound Vacuum-Assisted Closure (VAC); Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay	from time of admission to time of discharge (about 3 days from date of surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
time to return to work		From discharge (about 3 days from date of surgery) upto 1 year after surgery
Number of participants that need wound vac after discharge		At discharge (about 3 days from date of surgery)
Inpatient hospital costs		At discharge (about 3 days from date of surgery)
financial toxicity experienced by patients as assessed by the COST - FACIT survey	This is a 12 item questionnaire and each is scored from 0( not at all) to 4(very much), for a maximum score of 48, higher score indicating lower financial toxicity.	3 months after discharge
financial toxicity experienced by patients as assessed by the COST - FACIT survey	This is a 12 item questionnaire and each is scored from 0( not at all) to 4(very much), for a maximum score of 48, higher score indicating lower financial toxicity.	6 months after discharge
financial toxicity experienced by patients as assessed by the COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) survey	This is a 12 item questionnaire and each is scored from 0( not at all) to 4(very much). Questions 2,3,6 and 7 are reverse scored for a maximum score of 48, higher score indicating lower financial toxicity.	12 months after discharge

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jonah Stulberg, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Kerecis; Fish Skin Graft (FSG)
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Skin Diseases; Congenital Abnormalities; Skin Abnormalities; Keratosis; Surgical Wound; Wounds and Injuries; Ichthyosis
• Other Study ID Numbers: HSC-MS-24-1100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No