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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466776
• Other study ID #: 459-14
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2023
• Source: MemorialCare Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Obesity, Morbid
• Obesity, Severe

Intervention

Device:
• Absorbable subcuticular suture
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
• Stainless steel staples
Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).

Locations

Country	Name	City	State
United States	Long Beach Memorial Care Center	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 for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Hospital	Long Beach	California
United States	University of California, Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
MemorialCare Health System	University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Operating Surgeon Level	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Secondary	Surgical Assistant Level	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Secondary	Total Operative Time	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery and hospitalization
Secondary	Total Blood Loss	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of surgery
Secondary	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
Secondary	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
Secondary	Neonatal Birthweight	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	At time of delivery
Secondary	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
Secondary	Number of Participants Receiving Postpartum Prophylactic Anticoagulation	Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable	During hospitalization
Secondary	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
Secondary	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
Secondary	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