Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy

Baxter Healthcare Corporation75 enrolled

Overview

The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Face-lift Facial Rhytidectomy

Interventions

FS VH S/D 4 s-aprBIOLOGICAL

FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subject is 18 to 75 years of age at the time of screening * Subject is planned for facial rhytidectomy * Subject has read, understood and signed the written informed consent * Subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms * Subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study * Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: * Subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension * Subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) * Subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.) * Subject has undergone a prior rhytidectomy surgery * Subject is an active smoker, as assessed by the investigator * Subject has a known (documented) bleeding or coagulation disorder * Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery) * Subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension * Subject has diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 7 * Subject is receiving active treatment for a malignancy * Subject has a connective tissue disorder * Subject has an active or chronic skin disorder * Subject has history of Bell's palsy * Subject has a documented history of pathologically or pharmacologically induced immune deficiency * Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery * Subject has a known sensitivity to components of FS VH S/D 4 s-apr * Subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.) * Subject has documented healing complications following previous surgeries (eg, hypertrophic scarring) * Subject is pregnant or lactating at the time of enrollment * Subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study

Locations (6)

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Evans, Georgia, United States

Unnamed facility

Hewlett, New York, United States

Outcomes

Primary Outcomes

Total Volume of Drainage on Each Side of the Face

Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).

Time frame: 24 hours (± 4h) after surgery

Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)

Time frame: Day 0 (day of surgery) through postoperative Day 14

Secondary Outcomes

Participants' First Occurrence of Hematoma or Seroma by Study Day

Investigators assessed each side of the face for the presence of hematomas and/or seromas

Time frame: Day 0 (day of surgery) through postoperative day 14

Participants With Hematoma/Seroma by Study Day

Investigators assessed each side of the face for the presence of hematoma and/or seroma

Time frame: Day 0 (day of surgery) through postoperative day 14

Number of Participants With Hematoma/Seroma Anytime During the Study

Time frame: Day 0 (day of surgery) through postoperative Day 14

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 1

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Time frame: Through postoperative Day 1

Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3

Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema

Time frame: Through postoperative Day 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.