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

Primary Purpose

Cesarean Section Complications, Wound Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin preparation patterns with ChloraPrep 2 x 26 mL single
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Back and forth pattern

Circular pattern

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Skin bacterial burden
Culture bacterial burden prior to incision

Secondary Outcome Measures

Surgical site infection
Culture diagnosis of surgical site infections
Hospital Re-admissions
All cause hospital readmissions

Full Information

First Posted
March 9, 2020
Last Updated
January 30, 2023
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT04345562
Brief Title
Cesarean Section Skin Prep - Does Skin Preparation Pattern Affect Skin Bacterial Burden
Official Title
Cesarean Section Skin Prep - Does Skin Preparation Pattern Affect Skin Bacterial Burden
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Back and forth pattern
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Circular pattern
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin preparation patterns with ChloraPrep 2 x 26 mL single
Other Intervention Name(s)
ChloraPrep 2 x 26 mL single use applicators
Intervention Description
2 different patterns of skin preparation
Primary Outcome Measure Information:
Title
Skin bacterial burden
Description
Culture bacterial burden prior to incision
Time Frame
1-4 days
Secondary Outcome Measure Information:
Title
Surgical site infection
Description
Culture diagnosis of surgical site infections
Time Frame
4 weeks
Title
Hospital Re-admissions
Description
All cause hospital readmissions
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Admitted to the hospital for scheduled C-section. C-section incision must be Pfannenstiel Preoperative antibiotics administered in accordance with ACOG recommendations BMI >30 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan E Piacquadio, DO
Phone
2154566810
Email
megan.piacquadio@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Stampler, DO
Phone
2154566990
Email
stamplek@einstein.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan E Piacquadio, DO
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Cronin
Phone
267-886-7722
Email
croninse@einstein.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time there is no plan to share data with other researchers

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

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