Clinical trial NCT00959374: Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
Official title: A Prospective, Randomized Study to Evaluate Dermal Closure With an Absorbable Barbed Suture (V-Loc 180 Absorbable Wound Closure Device or V-Loc 90 Absorbable Wound Closure Device) as Compared to a Conventional Absorbable Suture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Ptosis
Obesity
Keywords: Abdominoplasty
Reduction Mammaplasty
Mastopexy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.

Detailed description: One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin.

Surgical sutures continue to be the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence.

Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.

Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject must be in good overall health.
* Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants.
* Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.

Exclusion Criteria:

* Subject is pregnant or breast-feeding.
* Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing.
* Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side.
* Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone.
* Subject has a BMI ≥ 40.
* Subject has diabetes requiring medication for glycemic control.
* Subject has a fever (temperature \> 38ºC), active skin infection or systemic infection at the time of surgery.
* Subject underwent chemotherapy or radiation within the last 6 months.
* Subject has a history of keloid or hypertrophic scar formation or other dermatologic conditions known to impair wound healing.
* Subject has a history of alcohol or drug abuse within 6 months prior to screening.
* Subject has a history of immunosuppressive drug use, including steroids, within the last 6 months.
* Subject has had a documented breast imaging finding or physical breast exam finding requiring further evaluation prior to elective surgery.
* Subject has not had a mammogram within the last 12 months, for female patients ≥ 40 years of age scheduled for mastopexy or reduction mammaplasty.
* Subject is taking part in another clinical study which directly relates to this study. If, however, the subject is taking part in a non-related study, the investigator should contact the Study Manager for advice.
* The investigator determines that the subject should not be included in the study for reasons not already specified.

Primary outcomes:
measure: Total Dermal Closure Time
timeFrame: At time of surgery
Secondary outcomes:
measure: Cosmesis
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Huntersville
country: United States
facility: The Hunstad Center for Cosmetic Plastic Surgery
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Frauenklinik
country: Germany
facility: University Hospital Bonn
state: Bonn
city: Boheimstrasse
country: Germany
facility: Marien Hospital Stuttgart
state: Stuttgart
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Peter Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References: