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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Skin Graft arm and Vacuum-Assisted Closure | Experimental |
| |
| Vacuum-Assisted Closure only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Skin Graft (FSG) | Device | FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | from time of admission to time of discharge (about 3 days from date of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonah Stulberg, MD | Contact | (713) 566-5098 | Jonah.J.Stulberg@uth.tmc.edu | |
| Debbie Lew | Contact | 713-566-5097 | Debbie.F.Lew@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonah Stulberg, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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Patients and nursing staff will be blinded to the patient's study arm. The operative physician will not be blinded
| Wound Vacuum-Assisted Closure (VAC) | Device | Participants will have a wound VAC applied to their wound bed at the time of surgical debridement. |
|
| 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 | 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. | 3 months after discharge |
| financial toxicity experienced by patients as assessed by the COST - FACIT survey | 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. | 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 | 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. | 12 months after discharge |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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