Not yet recruiting NCT06910189
Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fish Skin Graft (FSG), Wound Vacuum-Assisted Closure (VAC).
- Who it may be relevant to
- Registry conditions: Surgical Wound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Fish Skin Graft (FSG)
FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement - Device Wound Vacuum-Assisted Closure (VAC)
Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.
Primary outcome measures
- Hospital length of stay [Time frame: from time of admission to time of discharge (about 3 days from date of surgery)]
Secondary outcome measures (11)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06910189 · HSC-MS-24-1100