There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome. The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections
Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\~4-6 weeks postoperative) to rate scar quality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.
Standard abdominal dressing at the time of cesarean
Eskenazi Hospital
Indianapolis, Indiana, United States
Subjective Cosmetic Result
Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants.
Time frame: Week 6
Patient Satisfaction With Wound Appearance
Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied
Time frame: Week 6
Procedure Time in Minutes
Procedure time in minutes
Time frame: Start of surgery until application of wound vac immediately post-procedure
Analog Pain Scores 48 Hours
Participants respond with a scale of 1 - 10 with 10 as most severe and 1 as not at all. The full range provided reflects the actual collected data from the participants.
Time frame: 48 hours after surgery
Analog Pain Scores 72 Hours
Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.
Time frame: 72 hours after surgery
Analog Pain Scores @4 Weeks
Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.
Time frame: 4 weeks after surgery at postpartum visit
Analog Pain Scores @6 Weeks
Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.
Time frame: 6 weeks after surgery at postpartum visit
Incision Healing Complications up to 42 Days Postoperatively
Number of Participants with Incision Healing Complications up to 42 Days Postoperatively
Time frame: 42 day after surgery
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