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

Not Applicable

Not yet recruiting

• Conditions: Surgical Wound

• Registration Number: NCT06910189
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	from time of admission to time of discharge (about 3 days from date of surgery)

Secondary Outcome Measures

Name	Time	Method
Number of participants that have recurrent surgical site infection	Upto 1 year after surgery
Number of participants that require reoperation	Upto 1 year after surgery
Time to total wound healing	From end of surgery to upto 1 year after surgery
Number of participants that need skin graft	Upto 1 year after surgery
time from original surgery with placement of wound vac until the patient gets a skin graft	upto 1 year after surgery
time to return to work	From discharge (about 3 days from date of surgery) upto 1 year after surgery
Number of participants that need wound vac after discharge	At discharge (about 3 days from date of surgery)
Inpatient hospital costs	At discharge (about 3 days from date of surgery)
financial toxicity experienced by patients as assessed by the COST - FACIT survey	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.
financial toxicity experienced by patients as assessed by the COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) survey	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States