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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Obesity, Severe
• Intervention / Treatment: Device: Stainless steel staples; Device: Absorbable subcuticular suture

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 Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Care Center for Women at Miller Children's Hospital Long Beach
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Care Center
    • Orange, California, United States, 92868
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stainless steel staples; Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).	Device: Stainless steel staples; Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).; Other Names: Staples
Active Comparator: Absorbable subcuticular Suture; Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).	Device: Absorbable subcuticular suture; Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).; Other Names: 3-0 monocryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Skin Incision	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery and hospitalization
Operating Surgeon Level	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Surgical Assistant Level	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Total Operative Time	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery and hospitalization
Total Blood Loss	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Number of Participants With Blood Transfusion	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery and hospitalization
Change in Hemoglobin (Pre-delivery and Post-delivery)	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	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	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).	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	During hospitalization
Total Length of Hospital Stay	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	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).	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).	At time of hospital discharge and at 2 weeks postpartum

Collaborators and Investigators

• Sponsor: MemorialCare Health System
• Collaborators: University of California, Irvine
• Investigators: Principal Investigator: Jennifer McNulty, MD, MemoriaCare HealthSystem

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimated): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 459-14