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| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
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This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.
Wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. Moreover, appearance of the resulting scar depends largely on surgeon technique. Use of the Prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. Prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. The system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. Cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures.
The main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. The investigators hypothesize that operative time to closure of the final skin layer using Prineo™ will be faster than operative time to closure using subcuticular suture. The investigators also hypothesize that subjective and objective scar quality of incisions closed with Prineo™ will be better than those closed with subcuticular suture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prineo closure | Active Comparator | One breast will have skin closure with Prineo. |
|
| Standard Suture | No Intervention | One breast will be closed in the standard fashion with suture. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prineo | Device | After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time to Closure of Final Skin Layer | This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures. | During operation only |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Patient Observer Scar Assessment Scale (POSAS) | The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Vancouver Scar Scale (VSS) | A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar. | Up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Rohde, MD,MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15253184 | Background | Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. | |
| 16079683 | Background |
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21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prineo Closure OR Standard Suture | One breast will have skin closure with Prineo. Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures. OR One breast will be closed in the standard fashion with suture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm. The 21 subjects in the prineo arm are the same 21 subjects in the suture arm.
| ID | Title | Description |
|---|---|---|
| BG000 | Prineo Closure OR Standard Suture | One breast will have skin closure with Prineo. Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures. OR One breast will be closed in the standard fashion with suture. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Operative Time to Closure of Final Skin Layer | This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures. | 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts. | Posted | Mean | Standard Deviation | seconds | During operation only | Breasts | Breasts |
|
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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 | Prineo Closure OR Standard Suture | One breast will have skin closure with Prineo. Prineo: After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures. OR One breast will be closed in the standard fashion with suture. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Rohde, MD | Columbia University | 212-342-3707 | chr2111@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6. |
| 19909297 | Background | Dunst KM, Auboeck J, Zahel B, Raffier B, Huemer GM. Extensive allergic reaction to a new wound closure device (Prineo). Allergy. 2010 Jun 1;65(6):798-9. doi: 10.1111/j.1398-9995.2009.02243.x. Epub 2009 Nov 11. No abstract available. |
| Breasts |
|
| years |
| Participants |
|
| Sex: Female, Male | Only females were recruited for this study. | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
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One breast will be closed in the standard fashion with suture. |
|
|
| Secondary | Score on Patient Observer Scar Assessment Scale (POSAS) | The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar. | 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 year | Breasts | Breasts |
|
|
|
| Other Pre-specified | Score on the Vancouver Scar Scale (VSS) | A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar. | 21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 year | Breasts | Breasts |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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