Qualitative Comparison of Patient and Investigator Preferences Following the Use of Fibrin Sealant to Adhere Tissues and Improve Wound Healing in Patients Undergoing Rhytidectomy

INTRODUCTION:  A recent Phase III Study of Fibrin Sealant (FS) in Facial Rhytidectomy (Facelift) demonstrated significant reduction in drainage volumes for FS versus standard techniques.  The objective of this analysis was to compare preferences following the use of FS to adhere skin flaps in rhytidectomy.  METHODS:  Data were extracted from a phase III multi-center trial assessing efficacy and safety of a FS (ARTISS^â, Baxter Biosurgery, Westlake Village, CA).  All patients were kept blinded and received FS randomly on one side and standard of care (SOC) on the other side of their face so that the patient could serve as their own control.  Analysis included assessments gathered during multiple post-operative visits.  Patients and Investigators indicated preferences to aspects of treatment by scoring on a 5-point Likert scale.  Outcomes of interest included: (1) investigator and subject preferences for side of the face (2) investigator satisfaction with treatment, and confidence for reduced post-surgical complications.  RESULTS:  A total of 75 patients and 7 investigators provided qualitative comparisons during at least 1 of the 4 assessment days and were included in the analysis.  63%, 53%, 59%, and 57% of patients preferred the side of the face treated with FS at day 1, 3, 7 and day 14 post-operative, respectively.  The most common reasons cited for this preference were less swelling (78.7%), looks better (74.5%), less pain (48.9%), less bruising (44.7%), better skin sensation (40.4%), and less numbness (34%).  54.7% of investigators preferred the FS-treated side of the face as opposed to 17.3% of investigators preferring SOC.  This trend remaining consistent through Day 14 with 49.3% of investigators preferring the FS-treated side as opposed to 17.3% preferring SOC.  Investigators’ satisfaction with FS-treatment was consistent between Days 1, 3, 7 and 14 post-operative with investigators being very satisfied with treatment in 63.8%, 73.9%, 82.6%, and 84.1%, respectively.  Investigators were confident or somewhat confident for reduced post-surgical complications with the FS-treated side in 89.4% of patients at Day 1 with the same percentage reported through Day 14.  CONCLUSIONS:  A majority of patients and investigators reported preference for fibrin sealant and reported better appearance with FS compared to standard techniques.  Methods to aid the surgeon during rhytidectomy to increase patient satisfaction while reducing post-operative complications may be instrumental for ensuring optimal surgery-related outcomes.