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

March 27, 2025 updated by: Jonah Stulberg, The University of Texas Health Science Center, Houston
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hospital length of stay
Time Frame: from time of admission to time of discharge (about 3 days from date of surgery)
from time of admission to time of discharge (about 3 days from date of surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants that have recurrent surgical site infection
Time Frame: Upto 1 year after surgery
Upto 1 year after surgery
Number of participants that require reoperation
Time Frame: Upto 1 year after surgery
Upto 1 year after surgery
Time to total wound healing
Time Frame: From end of surgery to upto 1 year after surgery
From end of surgery to upto 1 year after surgery
Number of participants that need skin graft
Time Frame: Upto 1 year after surgery
Upto 1 year after surgery
time from original surgery with placement of wound vac until the patient gets a skin graft
Time Frame: upto 1 year after surgery
upto 1 year after surgery
time to return to work
Time Frame: From discharge (about 3 days from date of surgery) upto 1 year after surgery
From discharge (about 3 days from date of surgery) upto 1 year after surgery
Number of participants that need wound vac after discharge
Time Frame: At discharge (about 3 days from date of surgery)
At discharge (about 3 days from date of surgery)
Inpatient hospital costs
Time Frame: At discharge (about 3 days from date of surgery)
At discharge (about 3 days from date of surgery)
financial toxicity experienced by patients as assessed by the COST - FACIT survey
Time Frame: 3 months after discharge
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
Time Frame: 6 months after discharge
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
Time Frame: 12 months after discharge
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonah Stulberg, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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