TerminatedPhase 2

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Stopped: Protracted enrollment and limited wound closure in the first three subjects

United States3 participantsStarted 2017-04-24

Plain-language summary

About 20 participants will be enrolled in this trial if they have had an accident that damages both the dermal (outside) and epidermal (inside) layers of skin on up to 49% of their body. This condition is called full-thickness complex skin defects resulting from acute traumatic skin loss. Participants will be treated with StrataGraft skin tissue to evaluate it's safety and effectiveness for use in treating full-thickness complex skin defects.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women aged 18-65 years, inclusive
. Written informed consent
. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
. Complex skin defects of up to 49% Total Body Surface Area (TBSA) requiring excision and autografting
. Full-thickness complex skin defects requiring excision and autografting
. Study treatment sites on the torso and limbs may be up to 200 cm2 in cohort 1 and 400 cm2 in cohort 2
. For thermal burns only, first excision and grafting of treatment sites

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months

Timeframe: 3 months

Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months

Timeframe: 3 months

Trial details

NCT IDNCT03005054

SponsorStratatech, a Mallinckrodt Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-26

Results submitted2021-03-10

View on ClinicalTrials.gov More Trauma-related Wound trials