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

ConditionSurgical Wound
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Has wound greater than or equal to 40cm2 requiring surgical debridement

Agreeable to follow up period of up to 1 year

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fish Skin Graft (FSG)

    Device

    FSG will be applied to the wound bed, followed by a wound VAC at the time of surgical debridement

  • Wound Vacuum-Assisted Closure (VAC)

    Device

    Participants will have a wound VAC applied to their wound bed at the time of surgical debridement.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Fish Skin Graft arm and Vacuum-Assisted ClosureExperimental treatment 2 interventions
Group B: Vacuum-Assisted Closure onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital length of stay

Time frame
from time of admission to time of discharge (about 3 days from date of surgery)

Secondary outcomes

1

Number of participants that have recurrent surgical site infection

Time frame
Upto 1 year after surgery
2

Number of participants that require reoperation

Time frame
Upto 1 year after surgery
3

Time to total wound healing

Time frame
From end of surgery to upto 1 year after surgery
4

Number of participants that need skin graft

Time frame
Upto 1 year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: