Cesarean Section Skin Prep - Does Skin Preparation Pattern Affect Skin Bacterial Burden

NCT04345562 | Unknown DMC

• 1 other identifier: IRB-2019-165
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there is no study investigating best skin cleaning patterns prior to cesarean deliveries. As a result, doctors perform skin preparation using random unstudied techniques. Techniques vary from Hospital to Hospital and even within the same institution. The most widely used topical skin preparation is ChloraPrep and the manufacturer has not recommended a specific pattern to be used in order to abdominally prep prior to C-sections. In addition most studies do not examine the effectiveness in the obese population. The manufacture has established a recommended dosage area of 13in x13in per ChloraPrep stick as well as timing from initial preparation until the practice reached its maximum antiseptic benefit. Our current cesarean infection rate is very low, at just 1.6% over the last 12 months (September 2107-2018). This is significantly lower than the average cesarean section infection rate in the United States which is around 7.4% using iodine based preparations. Cesarean deliveries are one of the most common major surgeries performed in the United States, 31.9% of all births are by cesarean section. The risk of infection following a cesarean delivery is nearly 5 times that of a vaginal delivery. However, there is still no study that examines the pattern which ChloraPrep is applied to the abdomen prior to a cesarean delivery in patients with a BMI greater than 30. The pattern of skin preparation appears to be heavily related to physician training and personal bias.

Conditions

Cesarean Section Complications; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Skin bacterial burden

  Culture bacterial burden prior to incision

  1-4 days

Secondary Outcomes (2)

• Surgical site infection

  4 weeks

• Hospital Re-admissions

  4 weeks

Study Arms (2)

Back and forth pattern

ACTIVE COMPARATOR

Abdominal skin prep using ChloraPrep 2 x 26 mL single use applicators. The first applicator will be applied to the skin prep over the suspected skin incision site for 30 sec - the first applicator will then be used in a back and forth pattern work up towards the upper edge of the surgical field. The first applicator will then be discarded. The second applicator will then again start at the expected site of the incision and again working inferiority until the lower edge of the surgical field is reached.

Procedure: Skin preparation patterns with ChloraPrep 2 x 26 mL single

Circular pattern

ACTIVE COMPARATOR

Abdominal skin prep using ChloraPrep 2 x 26 mL single use applicators. The first applicator will be applied to the skin over the suspected skin incision site for 30 sec - the applicator will then be moved in a circular pattern moving outwards form the incision site until approximately half of thee surgical field is cleaned. The second applicator will then be used to complete the surgical prep until the entire surgical field is prepped in accordance with the package instructions.

Procedure: Skin preparation patterns with ChloraPrep 2 x 26 mL single

Interventions

Skin preparation patterns with ChloraPrep 2 x 26 mL single PROCEDURE

2 different patterns of skin preparation

Also known as: ChloraPrep 2 x 26 mL single use applicators

Back and forth pattern; Circular pattern

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the hospital for scheduled C-section.
• C-section incision must be Pfannenstiel
• Preoperative antibiotics administered in accordance with ACOG recommendations
• BMI \>30

You may not qualify if:

• Patient is currently on immunosuppression therapy.
• Patient is allergic to any medications or materials used during the research study
• BMI \>45 are excluded
• Patient refuses to participate in the study.
• Case is converted from plan to stat cesarean section
• Age less than 18
• If patient is determined to be unable to be consented

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19130, United States

RECRUITING

MeSH Terms

Conditions

Wound Infection

Interventions

Single Person

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Megan E Piacquadio, DO

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan E Piacquadio, DO

CONTACT

2154566810; megan.piacquadio@jefferson.edu

Kate Stampler, DO

CONTACT

2154566990; stamplek@einstein.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: April 14, 2020
• Study Start: February 2, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)