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NCT Number: NCT06910189

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

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Debbie Lew

CONTACT

[email protected]

713-566-5097

Jonah Stulberg, MD

CONTACT

[email protected]

(713) 566-5098

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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