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

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04345562
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications; Wound Infection	Procedure: Skin preparation patterns with ChloraPrep 2 x 26 mL single	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Cesarean Section Skin Prep - Does Skin Preparation Pattern Affect Skin Bacterial Burden
• Actual Study Start Date: Feb 2, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Skin preparation patterns with ChloraPrep 2 x 26 mL single; 2 different patterns of skin preparation; Other Names: ChloraPrep 2 x 26 mL single use applicators
Active Comparator: 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.	Procedure: Skin preparation patterns with ChloraPrep 2 x 26 mL single; 2 different patterns of skin preparation; Other Names: ChloraPrep 2 x 26 mL single use applicators

Outcome Measures

Primary Outcome Measures

1. Skin bacterial burden [1-4 days]

   Culture bacterial burden prior to incision

Secondary Outcome Measures

1. Surgical site infection [4 weeks]

   Culture diagnosis of surgical site infections

2. Hospital Re-admissions [4 weeks]

   All cause hospital readmissions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19130

Sponsors and Collaborators

• Albert Einstein Healthcare Network

Investigators

• Principal Investigator: Sean P Cronin, MD, Albert Einstein Healthcare Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sean Cronin, MD, Principal Investigator, Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT04345562
• Other Study ID Numbers: IRB-2019-165
• First Posted: Apr 14, 2020
• Last Update Posted: Jan 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wound Infection

Study Results

No Results Posted as of Jan 14, 2022