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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
Long Beach, California, United States
Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach
Long Beach, California, United States
Long Beach Memorial Care Center
Long Beach, California, United States
University of California, Irvine
Orange, California, United States
Composite Wound Complication at Hospital Discharge and 2 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.
Time frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Number of Participants According to Skin Incision
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
Operating Surgeon Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
Surgical Assistant Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
Total Operative Time
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
Total Blood Loss
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
Number of Participants With Blood Transfusion
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
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Change in Hemoglobin (Pre-delivery and Post-delivery)
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery (pre-delivery) and post-delivery
Neonatal Birthweight
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of delivery
Number of Participants With 5 Minute Apgar Score <7
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome).
Time frame: At time of delivery
Number of Participants Receiving Postpartum Prophylactic Anticoagulation
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: During hospitalization
Total Length of Hospital Stay
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
Patient Pain Score (From 1 to 10)
Patients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain).
Time frame: Within 2 weeks postpartum
Patient Satisfaction With Wound Healing and Appearance
Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned).
Time frame: At time of hospital discharge and at 2 weeks postpartum