CINCINNATI, OH (FOX19) - A Georgia family of a badly-burned little boy complained the government was blocking a potentially life-saving procedure.
It was an experimental surgery halted by the FDA because of some bad record-keeping. The family is now in Cincinnati, waiting for treatment at Shriners Burn Center.
The family started their week with good news that the FDA would now allow this experimental procedure to take place.
Now, they're waiting for word on-paper, before anything can take place at Shriners.
Alfred Real had just wrapped-up the school year. The second-grader suffered burns to more than 80-percent of his body. Doctors at an Atlanta hospital told his family he needed to be airlifted to Shriners Hospital in Cincinnati.
"He was taken there because it's the best pediatric burn center," said his aunt, Michelle Brethauer.
His aunt and uncle say the proposed surgery is still in the clinical trial phase. Doctors would take unburned skin from his head and quickly grow a large amount of new skin, in a lab, which would replace the burned skin on his body. Doctors predicted he could be home in less than three months.
"It's just a shorter, less painful process," his aunt said.
"It's what they believe is the best thing for Alfred and his best chance for full recovery," said his uncle, Rob Brethauer.
The family may have gotten the good word that the FDA has changed its mind over the phone, but they're still waiting for the official word on-paper from the FDA before they can move forward with any plans.
It has been tough on Alfred's parents, watching their son in a heavily sedated state, at his bedside at Shriners.
"It was hard to recognize him at first," said Brethauer. "Those first days when we were at the hospital. he was swollen and it was just a painful adjustment process for the entire family to go through."
Doctors had already prepared Alfred for the procedure, but the FDA stepped-in and the procedure had been stopped for everyone. Apparently, a 3-year FDA investigation found problems with patient data, such as adverse effects and case histories not being documented in the trial reports.
"It was really overwhelming," his aunt said. "It was a really bad day."
"There's other little children too that are getting burned that are going to need this," his uncle said. "And why not provide the best possible care and procedures and products you can, for these little children that are severely burned?"
Doctors would have been forced to use more traditional methods involving cadaver and synthetic skin, which would have left Alfred at a higher risk for infection and a much longer recovery.
Shriners tells FOX19, as soon as they get the word, Alfred will go into surgery for a skin biopsy and then still needs to be approved to take part in the clinical research trial.
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