The General and Plastic Surgery Devices Panel met on July 17, 2001 in Salons D&E at the Gaithersburg Hilton Hotel at 620 Perry Parkway Gaithersburg, Maryland, to provide advice and recommendations to the Agency for a premarket application submission.
The meeting consisted of a brief closed session and an open session. During the closed session, Mr. Stephen Rhodes (Branch Chief, PRSB/DGRD) gave the Panel Members a briefing on some of the devices they may be providing advice and recommendations on over the next year. After a short recess, the open portion of the panel meeting began at 10:30 am with Mr. Stephen Rhodes updating the committee on events related to panel activities that had occurred since the panel last met in May of 2000. In his update, Mr. Rhodes indicated that FDA had approved premarket applications for Focal, Inc.’s FocalSeal-L Synthetic Absorbable Sealant, Organogenesis Inc.’s Apligraf and for Mentor’s and McGhan’s Saline-filled Breast Implants. These products had been reviewed by the panel and recommended for approval in meetings during the year 2000. Finally, Mr. Rhodes indicated that the next meeting of the General and Plastic Surgery Devices Panel is tentatively scheduled for September 24 and 25, 2001.
The open session of the Panel meeting concerned a PMA for Ortec International’s OrCel™ (Composite Cultured Skin). The OrCel product is a preformed bovine collagen sponge matrix that is gel coated on one side. The device contains dermal allogeneic fibroblasts within the porous sponge and allogeneic skin keratinocytes on the gel-coated, non-porous side of the sponge. The focus of the discussion was on the preclinical and clinical data submitted by the sponsor in the PMA. The panel was asked to provide recommendations and advice to the Agency for the OrCel PMA.
The sponsor presentation highlighted the results obtained during the implementation of their multicenter, prospective, randomized, matched pair, controlled, single treatment, clinical trial that was performed at 12 centers in the US. The study involved the enrollment of 82 patients over the age of 12 months who had burns that covered at least 10% but no more than 80% of their bodies. The donor sites were required to be no smaller than 90 square centimeters and no larger than 360 square centimeters. These were to be virgin donor sites that were matched and were limited to a depth of between 0.0006 to 0.014 inches. Each enrolled patient had one donor site treated with OrCel and one donor site, of equivalent size, treated with the control dressing (Biobrane-L). Of the 82 enrolled patients, 60 completed the study.
The primary effectiveness endpoint was the time to 100% wound healing evaluated by photography. These photographs were to be presented in random order to three independent experts masked to study treatment. The secondary endpoints were time to 100% wound healing evaluated by planimetry performed by the unmasked investigator and analyzed at a central laboratory masked to treatment assignment, time to 100% wound healing as determined by the unmasked investigator, incidence of 100% wound healing and time to re-cropping of the donor site. Safety was assessed by evaluation of all study adverse events. Also, the study specific adverse events were evaluated such as signs of infection, confirmed infections, skin breakdown, skin blistering, pain and/or itching at the donor site. Scar outcomes at 12 and 24 weeks using the Vancouver and Hamilton Burn Scar Scales were also assessed.
Effectiveness evaluation demonstrated a statistical advantage in time to 100% healing for OrCel over control. Clinically, time to wound healing was noted to be at least comparable to control and substantially variable with covariates such as age, race, investigational center and oxandrolone use. Safety evaluations demonstrated no clinically or statistically significant differences in the safety profile of OrCel vs. control. During the panel deliberations, the committee was asked to comment on device effectiveness and device safety and whether the Vancouver Burn Scar and Hamilton Burn Scar Scores showed a clinically relevant difference in scores for OrCel and control treatments and to make recommendations regarding the proposed labeling. The panel agreed that the differences between OrCel and control outcomes for scar, while statistically in favor of OrCel, were not clinically significant. The panel suggested that while OrCel use on donor sites in burn patients might be considered; labeling should preclude OrCel use on burn wounds.
Following panel deliberations, the panel voted unanimously for approvable with conditions. The conditions of approval included further histological evaluation of OrCel™ (CSS)-treated donor sites and labeling modifications. The committee recommended that the modified labeling was to include no claims of device superiority for patients under 12 years of age and patients with burns over less than 20% of their body, no donor site recropping claims, a list identifying the types of patients excluded from the study, a cautionary statement on how to handle infected, treated donor sites and the specific data demonstrating the impact of oxandrolone-treatment on patients in the study. The majority of the Panel Members cited satisfaction with the safety data and a potential benefit for donor site healing in burn patients as the major contributing factor to their affirmative vote for approval.
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