Clinical trial NCT04345562: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Wound Infection
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Skin bacterial burden
timeFrame: 1-4 days
Secondary outcomes:
measure: Surgical site infection
timeFrame: 4 weeks
measure: Hospital Re-admissions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Megan E Piacquadio, DO
role: PRINCIPAL_INVESTIGATOR
References: