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

T. Roderick Hester, James R. Shire, Davis B. Nguyen, Zachary E. Gerut, Hung Chih Chen, Jason Diamond, Julian C. Desmond, Laura Silvati-Fidell, Steve Zvi Abrams, Rod J. Rohrich

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)487-496
Number of pages10
JournalAesthetic Surgery Journal
Volume33
Issue number4
DOIs
StatePublished - May 1 2013

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Rhytidoplasty
Fibrin Tissue Adhesive
Seroma
Standard of Care
Safety
Hematoma
Skin
Drainage
Extracellular Matrix Proteins
Suction
Dehydration
Abscess
Multicenter Studies
Therapeutics
Delivery of Health Care
Incidence
Wounds and Injuries

Keywords

  • facial surgery
  • fibrin sealant
  • rhytidectomy
  • tissue adherence

ASJC Scopus subject areas

  • Surgery

Cite this

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. / Hester, T. Roderick; Shire, James R.; Nguyen, Davis B.; Gerut, Zachary E.; Chen, Hung Chih; Diamond, Jason; Desmond, Julian C.; Silvati-Fidell, Laura; Abrams, Steve Zvi; Rohrich, Rod J.

In: Aesthetic Surgery Journal, Vol. 33, No. 4, 01.05.2013, p. 487-496.

Research output: Contribution to journalArticle

Hester, TR, Shire, JR, Nguyen, DB, Gerut, ZE, Chen, HC, Diamond, J, Desmond, JC, Silvati-Fidell, L, Abrams, SZ & Rohrich, RJ 2013, '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', Aesthetic Surgery Journal, vol. 33, no. 4, pp. 487-496. https://doi.org/10.1177/1090820X13479969
Hester, T. Roderick ; Shire, James R. ; Nguyen, Davis B. ; Gerut, Zachary E. ; Chen, Hung Chih ; Diamond, Jason ; Desmond, Julian C. ; Silvati-Fidell, Laura ; Abrams, Steve Zvi ; Rohrich, Rod J. / 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. In: Aesthetic Surgery Journal. 2013 ; Vol. 33, No. 4. pp. 487-496.
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abstract = "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.",
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AU - Hester, T. Roderick

AU - Shire, James R.

AU - Nguyen, Davis B.

AU - Gerut, Zachary E.

AU - Chen, Hung Chih

AU - Diamond, Jason

AU - Desmond, Julian C.

AU - Silvati-Fidell, Laura

AU - Abrams, Steve Zvi

AU - Rohrich, Rod J.

PY - 2013/5/1

Y1 - 2013/5/1

N2 - 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.

AB - 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.

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