## Protocol Section
### Identification Module
**NCT ID:** NCT06412978

**Brief Title:** Post-Operative Cesarean Section Cosmesis

**Official Title:** Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section

#### Organization Study ID Info
**ID:** IRB00109639
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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.

### Conditions Module

**Conditions:**

- Cesarean Delivery

**Keywords:**

- cosmetic improvement

- surgical correction

- Cosmesis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** trial comparing skin closure with absorbable subcuticular staples with subcuticular suture

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Scars will be digitally photographed by study staff and scored by 2 independent judges. The judges will be blinded to the closure method at time of scar evaluation.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 52

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Insorb absorbable staples are used for skin closure

**Intervention Names:**

- Procedure: absorbable subcuticular polyglycolic acid staples (INSORB)

**Label:** subcuticular absorbable polyglycolic acid (INSORB) staples

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Monocryl absorbable staples are used for skin closure

**Intervention Names:**

- Procedure: subcuticular, polyglecaprone suture (Monocryl)

**Label:** subcuticular absorbable polyglecaprone suture (Monocryl)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subcuticular absorbable polyglycolic acid (INSORB) staples

**Description:** Insorb absorbable staples are used for skin closure

**Name:** absorbable subcuticular polyglycolic acid staples (INSORB)

**Other Names:**

- INSORB

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- subcuticular absorbable polyglecaprone suture (Monocryl)

**Description:** Monocryl absorbable staples are used for skin closure

**Name:** subcuticular, polyglecaprone suture (Monocryl)

**Other Names:**

- Monocryl

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** scar cosmetic score

**Time Frame:** Week 6

#### Secondary Outcomes

**Description:** wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)

**Measure:** Number of Wound complications

**Time Frame:** Week 6

**Description:** days spent in hospital

**Measure:** length of hospital stay

**Time Frame:** Week 6

**Description:** amount of in-hospital intravenous opiate analgesic use

**Measure:** amount of in-hospital intravenous opiate analgesic use

**Time Frame:** Week 6

**Description:** amount of in-hospital oral NSAID analgesic use

**Measure:** amount of in-hospital oral NSAID analgesic use

**Time Frame:** Week 6

**Description:** amount of in-hospital oral opiate analgesic use

**Measure:** amount of in-hospital oral opiate analgesic use

**Time Frame:** Week 6

**Description:** 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.

**Measure:** patient rated subjective pain score

**Time Frame:** Week 6

**Description:** 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

**Measure:** patient's overall satisfaction with cosmesis scores

**Time Frame:** Week 6

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** Females requiring Cesarean Section

**Healthy Volunteers:** True

**Maximum Age:** 44 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ctulbert@wakehealth.edu

**Name:** Christina Tulbert

**Phone:** 336.716.2383

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Winston-Salem

**Contacts:**

***Contact 1:***

- **Email:** ctulbert@wakehealth.edu

- **Name:** Christina Tulbert

- **Phone:** 336-716-2383

- **Role:** CONTACT

***Contact 2:***

- **Name:** Joshua F Nitsche, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Joshua F Nitsche, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Investigators whose propose use of the data that has been approved by an Institutional Review Board

**Description:** All of the participant data collected during the trial and after deidentification

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Beginning 9 months and ending 36 months following article publication

**URL:** https://ctulbert@wakehealth.edu

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
