Clinical trial NCT02466776: Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Official title: Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Severe
Cesarean Section
Lead sponsor: MemorialCare Health System
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
First posted: 2015-06-09
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Women \> 18 years old undergoing cesarean delivery (CD)
2. BMI of \>/= 40 kg/m2 as determined by height and weight reported during their admission
3. Live gestation 23 weeks or greater
4. Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.

Exclusion Criteria:

1. Active lupus flare
2. HIV/AIDS
3. Current treatment for cancer or h/o radiation to the abdomen/pelvis
4. Hypersensitivity to steri-strips

Primary outcomes:
measure: Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
timeFrame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Secondary outcomes:
measure: Number of Participants According to Skin Incision
timeFrame: At time of surgery and hospitalization
measure: Operating Surgeon Level
timeFrame: At time of surgery
measure: Surgical Assistant Level
timeFrame: At time of surgery
measure: Total Operative Time
timeFrame: At time of surgery and hospitalization
measure: Total Blood Loss
timeFrame: At time of surgery
measure: Number of Participants With Blood Transfusion
timeFrame: At time of surgery and hospitalization
measure: Change in Hemoglobin (Pre-delivery and Post-delivery)
timeFrame: At time of surgery (pre-delivery) and post-delivery
measure: Neonatal Birthweight
timeFrame: At time of delivery
measure: Number of Participants With 5 Minute Apgar Score <7
timeFrame: At time of delivery
measure: Number of Participants Receiving Postpartum Prophylactic Anticoagulation
timeFrame: During hospitalization
measure: Total Length of Hospital Stay
timeFrame: At time of surgery and hospitalization
measure: Patient Pain Score (From 1 to 10)
timeFrame: Within 2 weeks postpartum
measure: Patient Satisfaction With Wound Healing and Appearance
timeFrame: At time of hospital discharge and at 2 weeks postpartum
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Care Center
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: MemoriaCare HealthSystem
name: Jennifer McNulty, MD
role: PRINCIPAL_INVESTIGATOR
References: