Description of Event or Problem · 1
CONTRACTURES [MUSCLE CONTRACTURE], BLISTERING [BLISTER], HYPOPIGMENTATION [SKIN HYPOPIGMENTATION], PRURITUS [PRURITIS], HYPERTROPHY OF SCARS [HYPERTROPHIC SCAR]. CASE DESCRIPTION: A PUBLISHED ARTICLE IN THE UNITED STATES TITLED "COVERAGE OF LARGE PEDIATRIC WOUNDS WITH CULTURED EPITHELIAL AUTOGRAFTS IN CONGENITAL NEVI AND BURNS: RESULTS AND TECHNIQUE." JOURNAL OF BURN CARE & RESEARCH 2009; VOLUME 30, NUMBER 4: 576-86 (SOOD, R., BALLEDUX, J., KOUMANIS, D., MIR, H., CHAUDHARI, S., ROGGY, D., ZIEGER, M., COHEN, A., AND COLEMAN, J.) WAS RECEIVED ON 04-OCT-2010. A RETROSPECTIVE SINGLE INSTITUTION REVIEW WAS DONE FOR 29 CHILDREN (20 BURNS AND 9 PTS WITH GIANT CONGENITAL NEVI (GCN)) WHO UNDERWENT COVERAGE OF THEIR LARGE SURFACE AREA WOUNDS WITH CULTURED EPITHELIAL AUTOGRAFTS (CEA) OVER AN 18-YEAR PERIOD. EXCELLENT TAKE RATES WERE NOTED; 76.4% FOR BURN PTS AND 66% FOR PTS WITH GCN. ALL OF THE PTS IN THE STUDY GROUP SURVIVED. IN THE BURN POPULATION, THE MEAN AGE OF THE PTS WAS 4.3 YEARS (RANGE, 0.5-17 YEARS) WITH 10 FEMALES AND 10 MALES. THE AVERAGE TOTAL BODY SURFACE AREA (TBSA) AFFECTED WAS 53.4% WITH 40% OF THE PTS SUFFERING INHALATION INJURY. BURN SEVERITY SCORE WAS 7.74, CALCULATED WITH ABBREVIATED BURN SEVERITY INDEX (ABSI). THE TOTAL TBSA AUTOGRAFTED WITH CULTURED KERATINOCYTES (CEA) WAS 29% WITH THE REMAINING REGIONS AUTOGRAFTED. THE MEAN TIME FOR CEA APPLICATION WAS 28.4 DAYS (RANGE, 21-46 DAYS). THE FINAL CEA TAKE RATE WAS 76.4% (RANGE 35-100%). THE AVERAGE NUMBER OF SURGERIES PERFORMED ON THE PT WAS 8.3 WITH ONLY ONE OF THE SURGERIES BEING WITH CEA. THERE WERE ONLY TWO PTS THAT NEEDED REGRAFTING WITH CEA. THE LENGTH OF HOSPITAL STAY AVERAGED 99 DAYS (RANGE, 45-226 DAYS) WITH A MEAN FOLLOW-UP OF 24.3 MONTHS. COMPLICATIONS WERE CATEGORIZED AS SHORT TERM AND LONG TERM. SHORT-TERM COMPLICATIONS INCLUDED BLISTERING IN FIVE PTS, HYPOPIGMENTATION IN TWO, PURITIS IN ONE, AND HYPERTROPHY OF SCARS IN ONE PT. THE MAJOR-LONG TERM COMPLICATION REPORTED WAS CONTRACTURES, WHICH OCCURRED IN 18 OF THE 20 PTS (90%). OVERALL, 70% OF THE PTS NEEDED RECONSTRUCTIVE SURGERY FOR THEIR CONTRACTURE. THE MOST FREQUENT AREAS REQUIRING CONTRACTURE RELEASES BEING FINGERS (N=5), AXILLA (N=6), KNEE (N=2) AND THE ELBOW (N=1). IN THE BURN POPULATION, THE TWO MAJOR COMPLICATIONS ASSOCIATED WITH THE USE OF CEA WERE SHEARING DUE TO FRAGILITY OF THE GRAFTS AND SECONDARY CONTRACTURES. TO AVOID SHEARING AND BLISTERING, JOINTS, HANDS, NECK, FEET, AND POSTERIOR ANATOMIC SITES, WHEN POSSIBLE, WERE COVERED WITH CONVENTIONAL AUTOGRAFTS, LEAVING CEA PLACEMENT TO THE ANTERIOR SURFACES SUCH AS THE THIGH, ABDOMEN, CHEST, ETC. WITH REGARDS TO CONTRACTURES, THE OVERALL RATE WAS HIGH IN THE PEDIATRIC POPULATION AT 90%. OF THE 18 OF 20 PTS WHO SUFFERED CONTRACTURES, 16 OF THOSE PTS DID NOT AT JOINTS SUCH AS THE AXILLA, HANDS, ELBOWS, AND GROINS. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PTS ADVERSE EVENTS WAS UNK. THIS LITERATURE ARTICLE WAS REVIEWED BY THE GENZYME GLOBAL SAFETY OFFICER (GSO) ON AN UNSPECIFIED DATE IN AUGUST 2009. ON 19-AUG-2009, THE GSO SPOKE WITH DR (B)(6) WHO CONFIRMED THE EVENTS WERE NOT RELATED TO EPICEL, BUT RATHER WERE NORMAL COMPLICATIONS IN BURN PTS. PER THE LITERATURE SOP IN AUGUST 2009, A CASE WAS NOT CREATED BECAUSE AT THAT TIME, LITERATURE CASES WERE CREATED BASED ON RELATION. ON 04-OCT-2010, THIS LITERATURE ARTICLE WAS RE-REVIEWED AND THIS CASE WAS CREATED AS A RESULT OF THE NEW LITERATURE SOP. (B)(4). MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF EPICEL IS NOT AFFECTED BY THIS REPORT.