Post-Operative Cesarean Section Cosmesis

Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Delivery
• Intervention / Treatment: Procedure: absorbable subcuticular polyglycolic acid staples (INSORB); Procedure: subcuticular, polyglecaprone suture (Monocryl)

Detailed Description

Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Tulbert; Phone Number: 336.716.2383; Email: ctulbert@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Principal Investigator: Joshua F Nitsche, MD
      • Contact: Christina Tulbert; Phone Number: 336-716-2383; Email: ctulbert@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-44
• Any race
• Any parity
• Scheduled cesarean section
• Neuraxial analgesia

Exclusion Criteria:

• Non-English Speaking
• Incarcerated
• Maternal Connective Tissue Disorder
• Systemic maternal steroid use
• Three prior cesarean deliveries
• Body Mass Index (BMI) >40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subcuticular absorbable polyglycolic acid (INSORB) staples; Insorb absorbable staples are used for skin closure	Procedure: absorbable subcuticular polyglycolic acid staples (INSORB); Insorb absorbable staples are used for skin closure; Other Names: INSORB
Active Comparator: subcuticular absorbable polyglecaprone suture (Monocryl); Monocryl absorbable staples are used for skin closure	Procedure: subcuticular, polyglecaprone suture (Monocryl); Monocryl absorbable staples are used for skin closure; Other Names: Monocryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scar cosmetic score	Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst).	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Wound complications	wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)	Week 6
length of hospital stay	days spent in hospital	Week 6
amount of in-hospital intravenous opiate analgesic use	amount of in-hospital intravenous opiate analgesic use	Week 6
amount of in-hospital oral NSAID analgesic use	amount of in-hospital oral NSAID analgesic use	Week 6
amount of in-hospital oral opiate analgesic use	amount of in-hospital oral opiate analgesic use	Week 6
patient rated subjective pain score	patient rated subjective pain score (0-10 based on visual analog scale) - 100-mm visual analog scale (VAS) ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.	Week 6
patient's overall satisfaction with cosmesis scores	The Patient and Observer Scar Assessment Scale (POSASA) All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). Higher scores meaning more scarring	Week 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joshua F Nitsche, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cosmesis; surgical correction; cosmetic improvement
• Other Study ID Numbers: IRB00109639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the participant data collected during the trial and after deidentification
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose propose use of the data that has been approved by an Institutional Review Board
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No