Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Subjective Cosmetic Result
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled or non-labor repeat cesarean delivery
- •One or more prior cesarean section(s) with prior pfannenstiel incision scar
- •Gestational age > 23 weeks
- •Age 18 and older
排除标准
- •Patients with malignancy in the wound bed or margins of the wound
- •Non-enteric and unexplored fistulas
- •Necrotic tissue with eschar present
- •Exposed arteries, veins, nerves or organs
- •Exposed anastomotic sites
- •Cellulitis or evidence of active infection
- •Known allergy to adhesive tape
- •Patient unwilling to follow-up
- •Contraindication to NPWT
- •Bleeding disorder
- •Therapeutic anticoagulation
- •Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient)
- •Prior irradiated skin
结局指标
主要结局
Subjective Cosmetic Result
时间窗: Week 6
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.
Patient Satisfaction With Wound Appearance
时间窗: Week 6
Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied
次要结局
- Analog Pain Scores 48 Hours(48 hours after surgery)
- Analog Pain Scores @4 Weeks(4 weeks after surgery at postpartum visit)
- Analog Pain Scores @6 Weeks(6 weeks after surgery at postpartum visit)
- Incision Healing Complications up to 42 Days Postoperatively(42 day after surgery)
- Procedure Time in Minutes(Start of surgery until application of wound vac immediately post-procedure)
- Analog Pain Scores 72 Hours(72 hours after surgery)
研究者
Lisa Annette Mims
Assistant Professor
Indiana University