Clinical trial NCT06910189: Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
Official title: Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Wound
Keywords: Fish Skin Graft (FSG)
Kerecis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital length of stay
timeFrame: from time of admission to time of discharge (about 3 days from date of surgery)
Secondary outcomes:
measure: Number of participants that have recurrent surgical site infection
timeFrame: Upto 1 year after surgery
measure: Number of participants that require reoperation
timeFrame: Upto 1 year after surgery
measure: Time to total wound healing
timeFrame: From end of surgery to upto 1 year after surgery
measure: Number of participants that need skin graft
timeFrame: Upto 1 year after surgery
measure: time from original surgery with placement of wound vac until the patient gets a skin graft
timeFrame: upto 1 year after surgery
measure: time to return to work
timeFrame: From discharge (about 3 days from date of surgery) upto 1 year after surgery
measure: Number of participants that need wound vac after discharge
timeFrame: At discharge (about 3 days from date of surgery)
measure: Inpatient hospital costs
timeFrame: At discharge (about 3 days from date of surgery)
measure: financial toxicity experienced by patients as assessed by the COST - FACIT survey
timeFrame: 3 months after discharge
measure: financial toxicity experienced by patients as assessed by the COST - FACIT survey
timeFrame: 6 months after discharge
measure: financial toxicity experienced by patients as assessed by the COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) survey
timeFrame: 12 months after discharge
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jonah Stulberg, MD
role: PRINCIPAL_INVESTIGATOR
References: