Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Seroma Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ARTISS

ARTISS will be used as an adjuvant to standard of care.

Group Type EXPERIMENTAL

FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)

Intervention Type BIOLOGICAL

Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.

Standard of care

Group Type OTHER

Standard of care

Intervention Type PROCEDURE

Standard of care

Interventions

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FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)

Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.

Intervention Type BIOLOGICAL

Standard of care

Intervention Type PROCEDURE

Other Intervention Names

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ARTISS

Eligibility Criteria

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Inclusion Criteria

* Subject is 18 to 75 years of age at the time of screening
* Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed)
* If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
* Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel)
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria

* Subject is obese (body mass index \[BMI\] \> 30 before surgery)
* Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery)
* Subject has a history of active smoking within the previous 12 months
* Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy
* Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted
* Subject is planned for other "body lifting" procedures (eg to the arms, legs, back etc.)
* Subject is planned for combined abdominoplasty with other cosmetic procedures including liposuction (restricted liposuction of the waist line and the lower back is allowed, as long as the integrity of the surgical spaces is maintained)
* Subject has an active or chronic skin disorder, history or evidence of keloid formation, or hypertrophic scarring
* Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome) requiring prescription medications
* Subject has a known abdominal hernia that requires mesh fixation
* Subject has a documented hiatal hernia or acid reflux disease
* Subjects with congenital or acquired immunodeficiency disorders
* Subject has uncontrolled diabetes mellitus (HbA1c \> 7.0)
* Subject has a history of cardio-vascular disease including uncontrolled hypertension (\> 140/90 mm Hg)
* Subject has a clinically diagnosed psychiatric disorder (including obsessive compulsive disorders)
* Subject has a known (documented) bleeding or coagulation disorder including history of thromboembolic events
* Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
* Subject is receiving active treatment for a malignancy
* Subject has a connective tissue disorder
* Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Subject has a known sensitivity to fibrin sealants
* Subject is a friend, employee, or relative of the investigator or other study personnel

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes