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Not yet recruitingNCT06910189Updated Apr 4, 2025

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

An interventional study of Fish Skin Graft (FSG) and Wound Vacuum-Assisted Closure (VAC) in Surgical Wound, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.

Planned enrollment
34th of 111
96 · median 50
Started
2025
with 6 others
No phase
88 of 129
9 open now
Primary completion
2025-11
later than 4 of 20 live
Registered
123rd of 129
by date

Among the 129 studies in Surgical Wound with a site in United States, this one is the 34th largest by planned enrollment of the 111 interventional ones that give a count, is one of 7 that started in 2025, is one of 88 with no phase, reaches primary completion later than 4 of the 20 other live ones, and was the 123rd registered.

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

Browse Surgical Wound studies →

Open to participants now

17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Surgical Wound

Browse trials for

Keywords

  • Fish Skin Graft (FSG)
  • Kerecis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Fish Skin Graft arm and Vacuum-Assisted Closure

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

  • Active comparator
    Vacuum-Assisted Closure only

    Device: Wound Vacuum-Assisted Closure (VAC)

Interventions

  • DeviceFish Skin Graft (FSG)

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

  • DeviceWound Vacuum-Assisted Closure (VAC)

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

06

What researchers measure

Primary outcomes

  1. Hospital length of stay

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

Secondary outcomes

  1. Number of participants that have recurrent surgical site infection

    Time frame: Upto 1 year after surgery

  2. Number of participants that require reoperation

    Time frame: Upto 1 year after surgery

  3. Time to total wound healing

    Time frame: From end of surgery to upto 1 year after surgery

  4. Number of participants that need skin graft

    Time frame: Upto 1 year after surgery

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

    Time frame: upto 1 year after surgery

  6. time to return to work

    Time frame: From discharge (about 3 days from date of surgery) upto 1 year after surgery

  7. Number of participants that need wound vac after discharge

    Time frame: At discharge (about 3 days from date of surgery)

  8. Inpatient hospital costs

    Time frame: At discharge (about 3 days from date of surgery)

  9. 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.

    Time frame: 3 months after discharge

  10. 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.

    Time frame: 6 months after discharge

  11. 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.

    Time frame: 12 months after discharge

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2025; primary completion for Nov 2025, 7 months later.

Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's planned 7 months is below that.

Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2025
First posted
Apr 4, 2025
StartEst.
Apr 15, 2025
Primary completionEst.
Nov 30, 2025
CompletionEst.
Nov 30, 2026
Last update
Apr 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06910189
Responsible party
Jonah Stulberg (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Apr 4, 2025
Start date
Apr 15, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 4, 2025

Study contacts

Jonah Stulberg, MD
Contact
Jonah.J.Stulberg@uth.tmc.edu
(713) 566-5098
Debbie Lew
Contact
Debbie.F.Lew@uth.tmc.edu
713-566-5097
Jonah Stulberg, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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