Recruiting

Observational Study

Sponsor:

Albert Einstein Healthcare Network

Code:

NCT04345562

Conditions

Cesarean Section Complications

Wound Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Skin preparation patterns with ChloraPrep 2 x 26 mL single

Study Details

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.

Conditions

Cesarean Section Complications

Wound Infection

Study ID

NCT04345562

Start date

Feb 2, 2021

Status verified date

Jan, 2023

Completion date

Sep, 2023

Anticipated

Primary completion date

Sep, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Skin preparation patterns with ChloraPrep 2 x 26 mL single

2 different patterns of skin preparation

Primary outcome measure

  • Skin bacterial burden [ Time Frame: 1-4 days ]

Central Contacts and Locations

Central contacts

Locations

Albert Einstein Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19130

Contacts

More Information

Sponsor

Albert Einstein Healthcare Network

Last update posted

Jan 31, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Albert Einstein Healthcare Network on 2023-01-31.