Use of Prineo in Breast Reduction Surgery (Prineo)
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|ClinicalTrials.gov Identifier: NCT01996917|
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Efficiency of Surgical Incision Closure Post-operative Scar||Device: Prineo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Use of Prineo™ for Wound Closure in Breast Reduction Surgery|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Prineo closure
One breast will have skin closure with 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.
Other Name: Prineo wound closure system
No Intervention: Standard Suture
One breast will be closed in the standard fashion with suture.
- Operative Time to Closure of Final Skin Layer [ Time Frame: During operation only ]This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.
- Score on Patient Observer Scar Assessment Scale (POSAS) [ Time Frame: Up to 1 year ]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.
- Score on the Vancouver Scar Scale (VSS) [ Time Frame: Up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996917
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Christine Rohde, MD,MPH||Columbia University|