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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00999141
Other study ID # 550901
Secondary ID
Status Completed
Phase Phase 3
First received October 20, 2009
Last updated October 4, 2012
Start date September 2009
Est. completion date February 2010

Study information

Verified date October 2012
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
FS VH S/D 4 s-apr
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participants' Assessment of Difference in Numbness Between Two Sides of Face During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:
How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?
Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)
The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests.
Through postoperative Day 14 No
Other Investigator Preference for Side of Face Investigator reported outcomes data was collected for overall preference for 1 side of face Through postoperative Day 14 No
Other Investigators' Satisfaction With Quality of Flap Adherence During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) Through postoperative Day 14 No
Other Investigators' Satisfaction With Rate of Healing During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) Through postoperative Day 14 No
Other Investigators' Satisfaction With Treatment During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face) Through postoperative Day 14 No
Other Investigators' Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr Through postoperative Day 14 No
Other Total Aspiration Volumes From Hematomas and Seromas Through postoperative Day 14 No
Primary 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). 24 hours (± 4h) after surgery No
Primary Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr) Day 0 (day of surgery) through postoperative Day 14 Yes
Secondary 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 Day 0 (day of surgery) through postoperative day 14 No
Secondary Participants With Hematoma/Seroma by Study Day Investigators assessed each side of the face for the presence of hematoma and/or seroma Day 0 (day of surgery) through postoperative day 14 No
Secondary Number of Participants With Hematoma/Seroma Anytime During the Study Day 0 (day of surgery) through postoperative Day 14 No
Secondary 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 Through postoperative Day 1 No
Secondary 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 Through postoperative Day 3 No
Secondary Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7 Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema Through postoperative Day 7 No
Secondary Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14 Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema Through postoperative Day 14 No
Secondary Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14 Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0). Day 0 (preoperative) through postoperative Day 14 No
Secondary Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14 Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Through postoperative Day 14 No
Secondary Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1 Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Through postoperative Day 1 No
Secondary Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3 Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Through postoperative Day 3 No
Secondary Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7 Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Through postoperative Day 7 No
Secondary Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14 Participants responded to the following question during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
Through postoperative Day 14 No
Secondary Reasons for Participants' Preferences for Side of Face Participants responded to the following questions during the side of face preference assessment:
"Which side of the face do you prefer? Left side, right side, or no preference?"
If "right" or "left" is chosen, participants were asked "Please mark ALL reasons for choosing this side"
Better skin sensation
Less numbness
Looks better
Less bruising
Less swelling
Less pain
Less itching
Less tingling
Less feeling of "pins and needles"
Other ________________ (Free Text)
Through postoperative Day 14 No