8 Year Old Boy With Severe Burns Denied Cultured Skin Treatment Due to FDA Letter Stating the Device Used “May” Produce Inaccurate Data?

The procedure has been done for the last 5 years at all the Shriner Hospitals up until the last 5 years ago, so this is not something brand new, and by growing his own skin back it certainly would be better than skin grafts and synthetic skin as this is what the boy will get.

This seems like a very strange case indeed as the methodologies of the data function of the device are superseding getting care to the boy who was burned over 80% of his body. It makes you ask where is the balance here when the procedure was done as a clinical trial for years? Who cares if the data is not absolutely correct and future devices and a fix for the software can be created, but if the over all procedure is life saving and not life threatening, what’s the deal here?

I hate to say it again but perhaps decision are being made without enough software and Health IT information and knowledge here, as again you need to look at the entire situation. BD

Family members of a Gwinnett County boy with third-degree burns covering 80 percent of his body are angry because they say he’s been denied a medical procedure by the U.S. Food and Drug Administration.

Alfred Real, 8, a rising third-grader at Arcado Elementary, is being treated at Shriners Hospital for Children in Cincinnati after suffering extensive burns in a June 7 fire in a wooded area not far from his Roe Hampton Lane home, near Stone Mountain.

After the accident, Alfred was taken to Grady Memorial Hospital, where his family was told his burns were so severe he required medical treatment elsewhere.

The Real family traveled to Cincinnati, where they were told a “cultured skin” procedure used to treat burns like Alfred’s was denied by the FDA. The procedure involves taking unburned skin from a person’s body and growing more of it in a lab. The procedure can replace burned skin more quickly and reduces the chance of infection, according to burnsurvivor.com, a Web site for burn victims.

Alfred already has undergone six surgical procedures — all of which used cadaver and synthetic skin — and two more are scheduled for the coming week.

The procedure is performed as part of a 20-year clinical trial conducted at Shriners Hospital by the University of Cincinnati.

The FDA recently has deemed cultured skin inappropriate for burn victims, according to Zac Real, Alfred’s father, who said he received a letter from the FDA on Saturday.

The FDA provided the AJC with a June 15 letter sent to the University of Cincinnati College of Medicine detailing the reason for denying the Real family. According to the letter, the family was denied due to concerns that the device used in the procedure may produce inaccurate data.

Since the procedure has not been approved, Alfred will undergo the traditional method of skin replacement, his family said.

Doctors may have to use Alfred’s scalp and scrotum to try and replace some of his burned skin, Real said.