Surgical Wound
Conditions
Keywords
Fish Skin Graft (FSG), Kerecis
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
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients and nursing staff will be blinded to the patient's study arm. The operative physician will not be blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital length of stay | from time of admission to time of discharge (about 3 days from date of surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of participants that have recurrent surgical site infection | 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 | 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. |
| 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. |
| time to return to work | From discharge (about 3 days from date of surgery) upto 1 year after surgery | — |
Countries
United States
Contacts
Primary ContactJonah Stulberg, MD
Backup ContactDebbie Lew
Outcome results
None listed