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

NCT ID: NCT06910189

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients and nursing staff will be blinded to the patient's study arm. The operative physician will not be blinded

Study Groups

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Fish Skin Graft arm and Vacuum-Assisted Closure

Group Type EXPERIMENTAL

Fish Skin Graft (FSG)

Intervention Type DEVICE

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

Wound Vacuum-Assisted Closure (VAC)

Intervention Type DEVICE

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

Vacuum-Assisted Closure only

Group Type ACTIVE_COMPARATOR

Wound Vacuum-Assisted Closure (VAC)

Intervention Type DEVICE

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

Interventions

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Fish Skin Graft (FSG)

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

Intervention Type DEVICE

Wound Vacuum-Assisted Closure (VAC)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jonah Stulberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonah Stulberg, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Jonah Stulberg, MD

Role: CONTACT

(713) 566-5098

Debbie Lew

Role: CONTACT

713-566-5097

Facility Contacts

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Jonah Stulberg, MD

Role: primary

(713) 566-5098

Debbie Lew

Role: backup

713-566-5097

Other Identifiers

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HSC-MS-24-1100

Identifier Type: -

Identifier Source: org_study_id

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