Description of Event or Problem · 1
SIXTY SIX YR OLD FEMALE PRESENTED TO MEDICAL CENTER ON 12/31/97 WITH NECROTIZING FASCITIS. THE INFECTION INVOLVED HER LEFT FOOT, LEG, LOWER LEFT ABDOMEN & GROIN, INCLUDING THE MADIAL AND LATERAL THIGHS, LEFT FLANK, & LEFT PERINEUM. PT WAS IN PROFOUND SEPTIC SHOCK, HYPERCATABOLIC, HAD ADULT RESPIRATORY DISTRESS SYNDROME, BILATERAL PNEUMOTHORACES & WAS INTUBATED. SHE UNDERWENT COLOSTOMY (FOR WOUND HYGIENE) & HAD A FEEDING GASTRIC TUBE. INFECTED AREAS WERE OPENED, DRAINED & AGGRESSIVE DEBRIDEMENT WAS DONE, INCLUDING RESECTION OF GREATER THAN 400 CM 2 OF SKIN FROM THIGH, PERINEUM AND ABDOMINAL WALL (LEFT LOWER QUADRANT). ON 1/20/98, DR. CONTACTED ADVANCED TISSUE SCIENCES, INC. ABOUT THE USE OF DERMAGRAFT-TC (TC) TO PROVIDE TEMPORARY CLOSURE OF THE PT'S WOUNDS UNTIL SHE COULD BE STABILIZED SUFFICIENTLY FOR SKIN GRAFTING AND PERMANENT CLOSURE. PT WAS NOW COMATOSE. ( AT LEAST PARTLY DUE TO SEDATION FOR ADULT RESPIRATORY DISTRESS SYNDROME WITH PROPOFOL). ON A VENTILATOR BECAUSE OF ADULT RESPIRATORY DISTRESS SYNDROME. PERMISSION WAS OBTAINED FOR EMERGENCY USE OF TC & AFTER TRAINING. 2 PIECES WERE APPLIED ON 1/21/98 TO THE LEFT ABDOMINAL WALL (MUSCLE AND FASCIAL). TC WAS NOT INITIALLY APPLIED TO THIGH BECAUSE OF UNACCEPTABLE WOUND BED. IN LATE FEBRUARY 98. 2 PIECES WERE APPLIED TO THE MEDIAL & LATERAL LEFT THIGH WOUNDS, AS THEY HAD IMPROVED. THE TC FUNCTIONED WELL OVER A 12 WEEK PERIOD (1/21-4/13/98) & THE PT PROGRESSED TO THE POINT THAT HER LEG WOUND WAS CLOSED TO THIGH LEVEL & THE DEVICE REMAINED ADHERENT TO THE UPPER THIGH & ABDOMINAL WALL. DR. STATED THAT THE DEVICE DIRECTLY AIDED IN HIS ABILITY TO STABILIZE THE PT & TO SAVE HER LIFE. ON 4/13/98. DR. REPORTED THAT HE HAD DIFFICULTY REMOVING THE DEVICE FROM THE PT'S UPPER THIGH & REQUIRED ELECTROCAUTERY. HE ALSO HAD DIFFICULTY REMOVING IT FROM THE ABDOMEN & REPORTED IT WAS SHREDDING WHEN HE TRIED TO REMOVE IT. AFTER THREE MONTHS ON THE WOUND, IT SEEMED TO HAVE BECOME TOO ADHERENT TO THE FASCIA & MUSCLE. ON 4/20/98, HE USED A C02 LASER TO REMOVE TC & ON 4/27 APPLIED A SKIN GRAFT. GRAFT IS FINE AS OF 5/5/98. PT STILL ON VENTILATOR DUE TO UNDERLYING CONDITION. CO DISCUSSED THE FACT THAT THE LABELING FOR THE DEVICE REPORTS THAT IN THE CLINICAL TRIALS IT WAS NECESSARY TO USE SURGICAL EXCISION TO REMOVE 6% OF THE TC COMPARED WITH 13.8 OF THE CONTROL ALLOGRAFT. THUS, THIS CASE DOES NOT REPRESENT A NEW TYPE OF EVENT, BUT ADDS USEFUL INFO, ESPECIALLY BECAUSE THIS PT WAS TREATED FOR NECROTIZING FASCITIS RATHER THAN A BURN WOUND. WHEN ASKED WHETHER THIS EVENT (ADHERENCE REQUIRING SURGICAL EXCISION FOR REMOVAL OF THE DEVICE) MET THE DEFINITION OF A "SERIOUS INJURY". DR. STATED THAT IT WAS NOT A "SERIOUS INJURY" ACCORDING TO THE REGULATORY DEFINITIONS PROVIDED. THE CO'S QUALITY AND MEDICAL AFFAIRS DEPARTMENTS ADVISED FILING AND MDR ANYWAY, DUE TO NON-ROUTINE EXCISION USED (C02 LASER).