Surgical WoundNCT06910189
Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
A study testing Fish Skin Graft (FSG) and Wound Vacuum-Assisted Closure (VAC) in people with Surgical Wound, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Fish Skin Graft (FSG) and Wound Vacuum-Assisted Closure (VAC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has wound greater than or equal to 40cm2 requiring surgical debridement
- Agreeable to follow up period of up to 1 year
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jonah Stulberg, MD, (713) 566-5098, Jonah.J.Stulberg@uth.tmc.edu
Debbie Lew, 713-566-5097, Debbie.F.Lew@uth.tmc.edu
About this study
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
- Being tested
- Fish Skin Graft (FSG), Wound Vacuum-Assisted Closure (VAC)
- Keywords
- Fish Skin Graft (FSG), Kerecis
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish Skin Graft (FSG)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)Device
Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.
| Study group | Role | What they receive |
|---|---|---|
| Fish Skin Graft arm and Vacuum-Assisted Closure | Experimental | Not described Receives: Device: Fish Skin Graft (FSG); Device: Wound Vacuum-Assisted Closure (VAC) |
| Vacuum-Assisted Closure only | Active comparator | Not described Receives: Device: Wound Vacuum-Assisted Closure (VAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: 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
Measured: Upto 1 year after surgery
Number of participants that require reoperation
Measured: Upto 1 year after surgery
Time to total wound healing
Measured: From end of surgery to upto 1 year after surgery
Number of participants that need skin graft
Measured: Upto 1 year after surgery
time from original surgery with placement of wound vac until the patient gets a skin graft
Measured: upto 1 year after surgery
time to return to work
Measured: From discharge (about 3 days from date of surgery) upto 1 year after surgery
Number of participants that need wound vac after discharge
Measured: At discharge (about 3 days from date of surgery)
Inpatient hospital costs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonah Stulberg, The University of Texas Health Science Center, Houston
- Investigators
- Jonah Stulberg, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910189
- Sponsor's protocol ID
- HSC-MS-24-1100
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
- ClinicalTrials.gov ID
- NCT06910189
- Acronym / sponsor ID
- HSC-MS-24-1100
- Conditions
- Surgical Wound
- Keywords
- Fish Skin Graft (FSG), Kerecis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has wound greater than or equal to 40cm2 requiring surgical debridement
- Agreeable to follow up period of up to 1 year
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish Skin Graft (FSG)FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement | Device | Fish Skin Graft arm and Vacuum-Assisted Closure |
| Wound Vacuum-Assisted Closure (VAC)Participants will have a wound VAC applied to their wound bed at the time of surgical debridement. | Device | Fish Skin Graft arm and Vacuum-Assisted Closure, Vacuum-Assisted Closure only |
Primary outcome
Hospital length of stay
Time frame: from time of admission to time of discharge (about 3 days from date of surgery)
11 secondary outcomes
Number of participants that have recurrent surgical site infection
Time frame: Upto 1 year after surgery
Number of participants that require reoperation
Time frame: Upto 1 year after surgery
Time to total wound healing
Time frame: From end of surgery to upto 1 year after surgery
Number of participants that need skin graft
Time frame: 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
time to return to work
Time frame: 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)
Inpatient hospital costs
Time frame: 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
financial toxicity experienced by patients as assessed by the COST - FACIT survey
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonah Stulberg, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Skin Graft (FSG) and Wound Vacuum-Assisted Closure (VAC) in people with Surgical Wound, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonah Stulberg, MD ((713) 566-5098, Jonah.J.Stulberg@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: from time of admission to time of discharge (about 3 days from date of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.