RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-02
Study Completion:2023-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04345562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Admitted to the hospital for scheduled C-section.
  2. 2. C-section incision must be Pfannenstiel
  3. 3. Preoperative antibiotics administered in accordance with ACOG recommendations
  4. 4. BMI \>30
  1. 1. Patient is currently on immunosuppression therapy.
  2. 2. Patient is allergic to any medications or materials used during the research study
  3. 3. BMI \>45 are excluded
  4. 4. Patient refuses to participate in the study.
  5. 5. Case is converted from plan to stat cesarean section
  6. 6. Age less than 18
  7. 7. If patient is determined to be unable to be consented

Contacts and Locations

Study Contact

Megan E Piacquadio, DO
CONTACT
2154566810
megan.piacquadio@jefferson.edu
Kate Stampler, DO
CONTACT
2154566990
stamplek@einstein.edu

Principal Investigator

Megan E Piacquadio, DO
PRINCIPAL_INVESTIGATOR
Albert Einstein Healthcare Network

Study Locations (Sites)

Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19130
United States

Collaborators and Investigators

Sponsor: Albert Einstein Healthcare Network

  • Megan E Piacquadio, DO, PRINCIPAL_INVESTIGATOR, Albert Einstein Healthcare Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-02
Study Completion Date2023-09

Study Record Updates

Study Start Date2021-02-02
Study Completion Date2023-09

Terms related to this study

Additional Relevant MeSH Terms

  • Cesarean Section Complications
  • Wound Infection