METHODS: Before initiation of the study, approval was obtained from the US Food and Drug Administration for an
Investigational New Drug Application and
off-label use of
Crosseal and from the Institutional Review Board of the University of California, Davis. Patients undergoing
rhytidectomy with or without concomitant procedures were voluntarily enrolled without compensation in the study (N = 9). Patients were randomized according to which side of the
rhytidectomy the tissue sealant was placed. In all patients in the study, 1 side of the
rhytidectomy was treated with
Crosseal; the other, untreated side was used as a control. Before closure of the skin, 2 mL of
Crosseal was sprayed through a pressure regulator under the skin flap of the dissected area of the
rhytidectomy only on 1 side. The skin was pretrimmed before placement and closed in standard fashion. A pressure dressing was left in place for 3 days before removal. Nine patients were originally enrolled in the study. On postoperative days 3 and 7, photographs were taken of the patients. The photographs were judged by 5 independent reviewers who were blinded as to which side had been treated with
Crosseal. The judges rated the degree of
ecchymoses on a scale of 1 (minimal) to 10 (severe) and were asked their opinion as to which side of the
facelift had been treated with
Crosseal. These results were compared using statistical analysis. Also on days 3 and 7, patients were examined for
seroma or
hematoma formation on each side of the face.
RESULTS: Our study demonstrated efficacy of
Crosseal in reducing
ecchymoses and swelling in all patients. The mean score for
ecchymosis on the
Crosseal-treated side was 4.5 and on the untreated (control) side was 6.2 (P < .01, Wilcoxon rank sum test). The rate of
hematoma or
seroma formation was 22% (2 of 9 patients) for the untreated side vs 0% (0 of 9 patients) for the treated side. This did not reach statistical significance (P = .43, Fisher exact test). Small
hematomas developed in 2 patients on the control side, which were needle aspirated. There were no known long-term complications from either the use of
Crosseal or the
rhytidectomy.
CONCLUSION: