Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

Not Applicable

Completed

Conditions: Obesity, Severe
Cesarean Section

Interventions: Device: Absorbable subcuticular suture
Device: Stainless steel staples

Registration Number: NCT02466776

Lead Sponsor: MemorialCare Health System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 238

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
HIV/AIDS
Current treatment for cancer or h/o radiation to the abdomen/pelvis
Hypersensitivity to steri-strips

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorbable subcuticular Suture	Absorbable subcuticular suture	Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Stainless steel staples	Stainless steel staples	Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).

Primary Outcome Measures

Name	Time	Method
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum	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 Outcome Measures

Name	Time	Method
Number of Participants With Blood Transfusion	At time of surgery and hospitalization	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Number of Participants Receiving Postpartum Prophylactic Anticoagulation	During hospitalization	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Patient Pain Score (From 1 to 10)	Within 2 weeks postpartum	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).
Number of Participants With 5 Minute Apgar Score <7	At time of delivery	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).
Total Length of Hospital Stay	At time of surgery and hospitalization	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Number of Participants According to Skin Incision	At time of surgery and hospitalization	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Operating Surgeon Level	At time of surgery	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Surgical Assistant Level	At time of surgery	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Change in Hemoglobin (Pre-delivery and Post-delivery)	At time of surgery (pre-delivery) and post-delivery	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Patient Satisfaction With Wound Healing and Appearance	At time of hospital discharge and at 2 weeks postpartum	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).
Total Operative Time	At time of surgery and hospitalization	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Total Blood Loss	At time of surgery	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Neonatal Birthweight	At time of delivery	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable

Trial Locations

Locations (4): University of California, Irvine
🇺🇸
Orange, California, United States
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