The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.
The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.
Columbia University Irving Medical Center/NYP
New York, New York, United States
Patient Scar Satisfaction Scale Score
The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.
Time frame: Assessed at 6-weeks postpartum
Incidence of Surgical Site Infection (SSI)
A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence.
Time frame: Up to 6 weeks post-surgery
Skin Closure Time
The skin closure time will be assessed.
Time frame: Intraoperative
Operative Time
The total operative time will be assessed.
Time frame: Intraoperative
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