The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
Standard of care
Mei Li Surgery Center
Beverly Hills, California, United States
Center for Plastic Surgery and Skin Care
Fort Lauderdale, Florida, United States
Miami Plastic Surgery
Miami, Florida, United States
Places Plastic Surgery
Atlanta, Georgia, United States
Total Drainage Volume Collected Until Drain Removal
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
Time frame: Day 0 (Surgery Day) to Day 90
Occurrence of Seroma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
Time frame: Day 0 (Surgery Day) to Day 90
Occurrence of Hematoma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.
Time frame: Day 0 (Surgery Day) to Day 90
Time to Drain Removal
The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc.
Time frame: Day 0 (Surgery Day) up to Day 90
Number of Fluid Aspiration for Seromas
Number of interventions recorded.
Time frame: Day 0 (Surgery Day) to Day 90
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The Practice of Gary Wiesman, M.D. and Irvin Wiesman, M.D. and Associates
Chicago, Illinois, United States
UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, United States
Total Volume of Fluid Aspirations for Seromas
Volume of fluid recovered was recorded.
Time frame: Day 0 (Surgery Day) to Day 90
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand \& Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Summary of Pain Assessment by Visit
Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90
Summary of Numbness Assessment by Visit
Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90