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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-loc and Monocryl | Active Comparator | Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-Loc 180/90 Wound Closure Device | Device | Barbed absorbable suture |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Dermal Closure Time | In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis | Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rubin, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Massachusetts Memorial Medical Center |
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First subject was consented 12Aug2009 and last subject final follow up visit 15May2011. 241 subjects were enrolled from 9 sites in the USA and Europe. Of those, 229 were consented, randomized and treated. All subjects were volunteers scheduled for individual or combined abdominoplasty, mastopexy or reduction mammaplasty.
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| ID | Title | Description |
|---|---|---|
| FG000 | V-loc and Monocryl | Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 3-0 Monocryl Absorbable Sutures |
| Device |
3-0 Monocryl Absorbable Suture (non-barbed) |
|
| 12 weeks |
| Worcester |
| Massachusetts |
| 01655 |
| United States |
| Albany Medical Center | Albany | New York | 12206 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| The Hunstad Center for Cosmetic Plastic Surgery | Huntersville | North Carolina | 28078 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| University Hospital Bonn | Frauenklinik | Bonn | 53127 | Germany |
| Marien Hospital Stuttgart | Boheimstrasse | Stuttgart | 70199 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V-loc and Monocryl | All randomized subjects |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Surgical Procedure | Must be scheduled for individual or combined abdominoplasty, mastopexy or reduction mammaplasty | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Dermal Closure Time | In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed. | Includes only those subjects where a deep dermal layer was closed. | Posted | Mean | Standard Deviation | Minutes | At time of surgery |
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| Secondary | Cosmesis | Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20). | Subjects who did not return for the 12 week follow-up visit were excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V-Loc 180 / 90 | Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. | 4 | 229 | 72 | 229 | ||
| EG001 | Control - Monocryl 3-0 | Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. | 1 | 229 | 44 | 229 | ||
| EG002 | Midline | Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm. | 0 | 229 | 19 | 229 | ||
| EG003 | Non-protocol Incision or Systemic Events | Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature. | 11 | 229 | 84 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Artery | Surgical and medical procedures | Systematic Assessment |
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| Wound Infection | Surgical and medical procedures | Systematic Assessment |
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| Wound Dehiscence (Adjudicated to Yes) | Surgical and medical procedures | Systematic Assessment |
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| Abcess | Surgical and medical procedures | Systematic Assessment |
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| Seroma | Surgical and medical procedures | Systematic Assessment |
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| Respiratory/Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Allergic Reaction | Surgical and medical procedures | Systematic Assessment |
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| Other - ecchymosis, light headedness and nausea | General disorders | Systematic Assessment |
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| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suture Extrusion | Surgical and medical procedures | Systematic Assessment | Suture extrusion without purulent discharge or abcess |
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| Wound Infection | Infections and infestations | Systematic Assessment |
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| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Granuloma | Surgical and medical procedures | Systematic Assessment |
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| Wound Dehiscence | Surgical and medical procedures | Systematic Assessment | Adjudicated and required surgery |
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| Wound Dehiscence | Surgical and medical procedures | Systematic Assessment | Did NOT require surgery |
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| Suture Extrusion | Surgical and medical procedures | Systematic Assessment | with purulent drainage |
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| Seroma | Surgical and medical procedures | Systematic Assessment |
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| Dermatitis | Surgical and medical procedures | Systematic Assessment |
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| Incision Pain | Surgical and medical procedures | Non-systematic Assessment |
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| Edema | Surgical and medical procedures | Systematic Assessment |
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| Erythema | Surgical and medical procedures | Systematic Assessment |
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| Other - ecchymosis, light headedness and nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Pollack M.D. Vice President Medical Affairs, STI | Covidien | 203-821-4719 | amy.pollack@covidien.com |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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