Cesarean Section Skin Prep - Does Skin Preparation Pattern Affect Skin Bacterial Burden
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
🗓️ Study Start (Actual) 2 February 2021
🗓️ Primary Completion (Estimated) September 2023
✅ Study Completion (Estimated) September 2023
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 9 March 2020
  • First Submitted that Met QC Criteria 13 April 2020
  • First Posted 14 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 January 2023
  • Last Update Posted 31 January 2023
  • Last Verified January 2023