Efficiency of Surgical Incision Closure Clinical Trial
Official title:
Use of Prineo™ for Wound Closure in Breast Reduction Surgery
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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