Randomized, controlled, phase 3 study to evaluate the safety and efficacy of fibrin sealant VH S/D 4 s-apr (Artiss) to improve tissue adherence in subjects undergoing rhytidectomy.

BACKGROUND: Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps. OBJECTIVES: The authors evaluate the safety and efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (Artiss; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy. METHODS: Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other. RESULTS: Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0 (11.3) mL from the SoC-only sides (P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration). CONCLUSIONS: Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence. LEVEL OF EVIDENCE: 2.

Exploratory, randomized, controlled, phase 2 study to evaluate the safety and efficacy of adjuvant fibrin sealant VH S/D 4 S-Apr (ARTISS) in patients undergoing rhytidectomy.

BACKGROUND: Suction drains are commonly placed after rhytidectomy surgery to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by cross-linking with extracellular matrix proteins, which may reduce the dead space under skin flaps. OBJECTIVES: The authors evaluate the safety and preliminary efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (ARTISS; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, on tissue plane adherence and local hemostasis in rhytidectomy patients. METHODS: In this phase 2, prospective, controlled, randomized, evaluator- and patient-blinded, multicenter study, 45 patients (of 56 possible enrollees) received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr treatment on the other side. Outcomes measures included visual assessments of ecchymosis (by blinded reviewers), grading of ecchymosis and edema, drainage volumes, occurrence of hematoma/seroma, safety evaluations, and patient-reported assessments of pain, numbness, and treatment preferences postoperatively. RESULTS: Mean patient age was 55.1 years. Rates and grades of ecchymosis and edema were similar for the 2 treatments. The mean (SD) drainage volume 24 hours after surgery was 11.5 (13.7) mL from the FS VH S/D 4 s-apr-treated sides of the face and 26.8 (24.0) mL from the SoC-only sides (P < .0001). Patient assessments of pain, numbness, and preference favored treatment with FS VH S/D 4 s-apr. Adverse events were mild to moderate in severity. CONCLUSIONS: Adjuvant use of FS VH S/D 4 s-apr appears to be safe and results in lower drainage volumes than SoC treatment alone.

Experience with fibrin glue in rhytidectomy.

BACKGROUND: The authors conducted a large, prospective, controlled trial of fibrin glue in rhytidectomy using a wide set of variables. METHODS: Two hundred consecutive patients undergoing elective rhytidectomy were studied. One hundred patients received fibrin glue over a 1-year period and were followed prospectively. Another 100 patients from the previous year who had not received fibrin glue had their charts reviewed retrospectively. All patients underwent bilateral face lifts using the deep plane technique. RESULTS: The following data were observed for the glue versus nonglue patients: expanding hematoma rate, 1 percent versus 3 percent (p > 0.05); seroma rate, 1 percent versus 7 percent (p > 0.05); and prolonged induration, edema, and ecchymosis, 0 percent versus 22 percent (p < 0.05). The pain score for glue versus nonglue patients was 100 percent minimal versus 95 percent minimal and 5 percent moderate (p > 0.05). The average score for patient satisfaction (scale, 1 to 10, with 10 being best) for glue versus nonglue patients was 9.5 versus 9.0 (p > 0.05). CONCLUSIONS: The use of fibrin glue was associated with some benefits for rhytidectomy. Fibrin glue eliminated the use of drains. The difference in expanding hematoma was clinically, but not statistically, significant. The seroma rate was decreased and neared statistical significance. There was an impressive immediate decrease in postoperative swelling. The fibrin glue was most advantageous in eliminating prolonged induration, edema, and ecchymosis. There were no statistical differences between groups for patient satisfaction or pain. The use of fibrin glue has been shown to reduce some of the morbidity and severe complications of face lifting.

Multivectored suture suspension: a minimally invasive technique for reanimation of the paralyzed face.

BACKGROUND: Despite advanced techniques for reanimation of the lower face, many patients opt for static suspension procedures, which are less invasive and have a relatively short recovery period. However, even static suspension procedures require general anesthesia, overnight hospital stay, and significant soft tissue manipulation. We present a minimally invasive technique, the multivectored suture suspension, which addresses these drawbacks. OBJECTIVES: To study the technical feasibility and efficacy of the multivectored suture suspension technique in the paralyzed face. DESIGN: The study was carried out prospectively in 12 patients with House-Brackmann grade 6 facial paralysis. Nine patients presented within 6 months of tumor resection and 3 patients presented more than 1 year after surgery. MAIN OUTCOME MEASURES: The parameters evaluated were (1). restoration of nasal breathing; (2). improvement of drooling; (3). restoration of normal speech; (4). cosmetic results; and (5). total surgical time. RESULTS: With an average follow-up of 14 months, patient evaluation of the outcome parameters was as follows: (1). 10 patients (83%) reported significant and 2 (17%) reported moderate restoration of nasal breathing; (2). 10 patients (83%) reported significant improvement and 2 (17%) reported modest drooling improvement; (3). 8 patients (66%) reported significant improvement and 4 (34%) reported modest improvement of speech; (4). 9 patients (75%) reported complete satisfaction and 3 (25%) reported moderate satisfaction with cosmesis. The average surgical time was 46 minutes. Three revisions were required for suture failure. CONCLUSIONS: The multivectored suture suspension technique is a minimally invasive, reversible method of lower facial reanimation that provides improved cosmesis with restoration of nasal breathing. It can be performed under local anesthesia in an outpatient setting, thereby reducing morbidity and cost.

Eosinophilic angiocentric fibrosis in a patient with nasal obstruction.

Eosinophilic angiocentric fibrosis (EAF) is a rare clinicopathologic entity that usually affects the upper respiratory tract. We describe the case of a 45-year-old man with nasal obstruction caused by EAF. His lesion featured the distinct radiologic and histopathologic characteristics of EAF, which include an onionskin and whorled fibrosis that surrounds the blood vessels and an inflammatory infiltrate that is predominated by eosinophils. The etiology of EAF remains unknown. Given our increasing knowledge of this rare entity, reports of EAF may appear more frequently in the future.