Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MemorialCare Health System
- Enrollment
- 238
- Locations
- 4
- Primary Endpoint
- Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Study Overview
Brief Summary
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.
Detailed Description
A. To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).
B. No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).
C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women > 18 years old undergoing cesarean delivery (CD)
- •BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
- •Live gestation 23 weeks or greater
- •Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
Exclusion Criteria
- •Active lupus flare
- •Current treatment for cancer or h/o radiation to the abdomen/pelvis
- •Hypersensitivity to steri-strips
Arms & Interventions
Stainless steel staples
Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Intervention: Stainless steel staples (Device)
Absorbable subcuticular Suture
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Intervention: Absorbable subcuticular suture (Device)
Outcomes
Primary Outcomes
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Time Frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Secondary Outcomes
- Number of Participants Receiving Postpartum Prophylactic Anticoagulation(During hospitalization)
- Patient Pain Score (From 1 to 10)(Within 2 weeks postpartum)
- Number of Participants According to Skin Incision(At time of surgery and hospitalization)
- Operating Surgeon Level(At time of surgery)
- Surgical Assistant Level(At time of surgery)
- Change in Hemoglobin (Pre-delivery and Post-delivery)(At time of surgery (pre-delivery) and post-delivery)
- Patient Satisfaction With Wound Healing and Appearance(At time of hospital discharge and at 2 weeks postpartum)
- Number of Participants With Blood Transfusion(At time of surgery and hospitalization)
- Number of Participants With 5 Minute Apgar Score <7(At time of delivery)
- Total Length of Hospital Stay(At time of surgery and hospitalization)
- Total Operative Time(At time of surgery and hospitalization)
- Total Blood Loss(At time of surgery)
- Neonatal Birthweight(At time of delivery)
Investigators
Jennifer McNulty, MD
Maternal Fetal Medicine Specialist
MemorialCare Health System