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

NCT ID: NCT04345562

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2023-09-30

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.

Detailed Description

Currently there is no study investigating optimal skin preparations patterns prior to cesarean deliveries. As a result, there are many practitioners that perform skin preparation, cleaning of the surgical site, using random unstudied patterns. Patterns 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. They have published data instructing one on the surface area for which a ChloraPrep stick is verified to be used for as well as timing from initial preparation until the cleaner has reached its maximum antiseptic benefit.

Our current cesarean infection rate is 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 estimated to be around 7.4%.[i] Cesarean deliveries are one of the most common major surgeries performed in the united states, 31.9% of all births are by cesarean section.[ii] The risk of infection following a cesarean delivery is nearly 5 times that of a vaginal delivery[iii]. However, there is still no study that examines the pattern which ChloraPrep, the most widely used skin cleaner, is applied to the abdomen prior to a cesarean delivery.

There is currently no study that looks at pattern of skin preparation prior to cesarean section. The manufacture simply recommends gentle scrubbing. The pattern of skin preparation appears to be related to your training.

This study aims to look at topical skin preparation patterns prior to cesarean section. As a proxy for likelihood of infection the investigators will collect data on surface bacterial burden prior to incision but after abdominal prep is complete as well as post surgically. The assumption is that if there is a significant skin burden postoperatively that one method of skin preparation is superior to the other.

Conditions

Cesarean Section Complications; Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Back and forth pattern

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.

Group Type: ACTIVE_COMPARATOR

Skin preparation patterns with ChloraPrep 2 x 26 mL single

Intervention Type: PROCEDURE

2 different patterns of skin preparation

Circular pattern

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.

Group Type: ACTIVE_COMPARATOR

Skin preparation patterns with ChloraPrep 2 x 26 mL single

Intervention Type: PROCEDURE

2 different patterns of skin preparation

Interventions

Skin preparation patterns with ChloraPrep 2 x 26 mL single

2 different patterns of skin preparation

Intervention Type: PROCEDURE

Other Intervention Names

ChloraPrep 2 x 26 mL single use applicators

Eligibility Criteria

Inclusion Criteria

1. Admitted to the hospital for scheduled C-section.

2. C-section incision must be Pfannenstiel

3. Preoperative antibiotics administered in accordance with ACOG recommendations

4. BMI >30

Exclusion Criteria

1. Patient is currently on immunosuppression therapy.

2. Patient is allergic to any medications or materials used during the research study

3. BMI >45 are excluded

4. Patient refuses to participate in the study.

5. Case is converted from plan to stat cesarean section

6. Age less than 18

7. If patient is determined to be unable to be consented

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Megan Piacquadio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan E Piacquadio, DO

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan E Piacquadio, DO

Role: CONTACT

megan.piacquadio@jefferson.edu

2154566810

Kate Stampler, DO

Role: CONTACT

stamplek@einstein.edu

2154566990

Facility Contacts

Sean Cronin

Role: primary

croninse@einstein.edu

267-886-7722

Other Identifiers

IRB-2019-165

Identifier Type: -

Identifier Source: org_study_id