Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

Baxter

Status and phase: Completed; Phase 2

Conditions: Facial Rhytidectomy (Face-lift)

Treatments: Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708071

550703

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects planned for facial rhytidectomy
• Subjects who read, understand and sign the written informed consent
• Healthy female or male subjects as determined by the investigator using standard pre-operative assessments to include laboratory tests and ECG
• Subjects 18-75 years old, inclusively
• Subjects who are able and willing to comply with the protocol requirements
• Female subjects of childbearing potential with a negative urine or serum pregnancy test within 72 hours of surgery

Exclusion criteria

• Pregnant or lactating women
• Subjects who have undergone previous face-lift surgery
• Subjects undergoing abbreviated face-lift procedures such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension
• Subjects indicated for concurrent facial surgeries during the operation (e.g. forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.)
• Subjects indicated for additional procedures during the same operation (e.g., liposuction, mastoplasty etc.)
• Subjects who had prior silicone injections to their face (Botox and/or Restylane are allowed)
• Subjects considered by the investigator to be smokers
• Subjects with ecchymosis and/or edema on the face on day 0, prior to surgery
• Subjects with known (documented) bleeding or coagulation disorders
• Subjects currently being treated with anti-coagulants
• Subjects treated with Aspirin in the last 7 days or use of other Non-steroidal anti-inflammatory drug (NSAIDs) within the last 7 days prior to surgery
• Subjects with vascular disorders, cardiovascular disease, and/or uncontrolled hypertension
• Subjects with diabetes mellitus
• Subjects with a history of Bell´s palsy
• Subjects with connective tissue disorders
• Subjects with documented history of pathologically or pharmacologically induced immune deficiency
• Subjects receiving systemic corticosteroid treatment for a chronic condition within 2 to 30 days prior to the surgery
• Subjects with a known sensitivity to fibrin sealants
• Subjects with a known psychiatric disorder (e.g., depression, obsessive compulsive disorder, anxiety, eating disorders, etc)
• Subjects who have participated in another clinical study within 30 days prior to this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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45 participants in 1 patient group

1

Experimental group

Description:

One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.

Treatment:

Biological: Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)