Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
Phase: PHASE4
Conditions: Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction, Surgical Wound Infection
Sponsor: The University of Texas Medical Branch, Galveston

 
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The University of Texas Medical Branch at Galveston 
 
Research Protocol #18-0265 
 
 
Title: Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing 
Cesarean Delivery: A Randomized Control Trial 
 
 
 
 
NCT03887299 
 
 
Prepared by: 
 
Antonio Saad, MD, MFM (Principal Investigator) 
The University of Texas Medical Branch 
301 University Blvd. 
Galveston TX, 77555 
 
George Saade, MD, MFM (Co- Principal Investigator) 
The University of Texas Medical Branch 
301 University Blvd. 
Galveston TX, 77555 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. Introduction and Purpose: 
Surgical site infection (SSI) is a major cause of morbidity in obstetrics. Cesarean 
delivery is the most common surgical procedure performed in pregnancy. Cesarean 
delivery rates are on the rise worldwide. At the same time, obesity, a known risk 
factors for SSI, has become an epidemic. Interventions which prevent SSI could have a 
significant impact on maternal health, as well as the cost of maternity care. Incisional 
SSI can be affected by multiple pre- or intra-operative variables, but there is little data 
regarding the impact of postoperative wound care, especially type of postoperative 
wound dressing, on SSI. Our objective is to evaluate the effect of a novel antimicrobial 
dressing on patient's satisfaction and health related quality of life before beginning the 
pivotal trial about its efficacy in decreasing SSI rates. 
 
2. Background: 
Cesarean delivery is the most common surgical procedure in the USA. Despite a 
concerted effort to decrease the cesarean delivery rate, it continues to hover around 
30%, and is unlikely to decrease. SSI is a major contributor to obstetrical morbidity, 
hospital readmission, and higher health care cost. Risk factors that have been 
associated with incisional SSI include surgery type, administration of perioperative 
antibiotic prophylaxis, and patient’s comorbidities. In contrast, the relationship 
between postoperative wound care, especially wound dressing types, and SSI remains 
to be elucidated.  Recently, a post-operative dressing that integrates the antimicrobial 
properties of chlorhexidine gluconate (CHG), the practicality of absorbency, and the 
convenience of transparency has been approved by the FDA.  Its antimicrobial and 
absorption properties in conjunction with its convenient features (transparent and 
adherent) makes it an optimal dressing for our obstetrical population. At UTMB, these 
dressings are available to surgeons and may be used at the physician’s discretion. They 
have been evaluated in 20 post-cesarean patients with very positive feedbacks from 
patients and medical staff. As there are no clinical trials focusing on these novel 
dressing types, and because the risk factors and pathogenesis for post-cesarean SSI 
may not mirror other surgical procedures, level 1 evidence specific to pregnancy is 
needed before extrapolating the results from other types of surgeries to cesarean 
procedures. 
 
3. Concise Summary of Project: 
This will be an open label pilot randomized controlled clinical trial. Women undergoing 
cesarean delivery will be randomized to have standard wound dressing care or CHG 
impregnated wound dressing (ReliaTect™ Post-Op Dressing). We will exclude women 
with chorioamnionitis, immunosuppression, active skin infection, contraindication to 

 
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CHG (allergy), those unlikely to be followed-up after delivery, or unable to provide 
consent. 
 
Subjects requiring cesarean delivery and without exclusion criteria will be informed by 
the obstetrical team about the study and asked for permission to contact the study 
personnel. Written informed consent will be obtained by person-to-person contact. 
The research staff will be responsible for the informed consent. 
 
Subjects who agree to participate in the study will be randomized to one of the two 
groups below in a 1/1 allocation: 
• Standard Wound Care: Wound dressing and care as per our current practice. 
Compression dressing consisting of gauze, tefla and adhesive tape will be placed 
intraoperatively. Dressing will be removed after 24 hours from surgery 
completion and subjects will have an absorption pad with overlying garments for 
the remaining postoperative days until standard postoperative visit for wound 
check.  
• CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the 
manufacturer’s instructions (Appendix A) intraoperatively. The dressing will be in 
place until the postoperative clinic visit on postoperative day 7. 
 
The remainder of the subjects’ care will be similar for both arms and will follow current 
standard clinical practice at the University of Texas Medical Branch (UTMB). The study 
period will be between February 2019, and February 2020. The number of subjects to 
be studied at UTMB will be 160. A subject will be withdrawn from the study if she 
wishes to discontinue participation. 
 
4. Study Procedures: 
After a subject who meets eligibility criteria agrees to participate in the study, the 
obstetrical team will contact the research staff who will obtain a signed informed 
consent.  
 
The data collected will be kept on a password-secured UTMB computer. An encrypted 
USB flash drive will be used to transfer data. The data will be linked to the subject by 
subject's MRN number. This identifier is needed to access and analyze demographic 
data. During analysis of the data, all identifiers will be deleted. 
 
4.1 Screening Recruitment and Consenting: 
Under the direction of the PI, trained research staff will be available 24/7 to screen and 
consent subjects. Subjects will be enrolled at the time of admission to labor and 
delivery (L&D) for delivery or thereafter. Medical records of all potential subjects will 

 
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be reviewed and those who satisfy eligibility criteria will be approached and written 
informed consent obtained. A screening log will be used to track all subjects 
approached for the study. Women will be randomized in the operating room when the 
decision is made to proceed with skin closure AND they continue to be eligible. 
 
Recruitment: We will offer the trial to all pregnant subjects admitted to L&D and who 
meet our eligibility criteria. Whenever practical and feasible, information about our 
research project will be made available to subjects prior to labor. We will not consent 
subjects who appear not to be able to evaluate their options (such as recent 
intravenous narcotics). This strategy is currently followed in other approved OB/GYN 
studies with similar recruitment timing, and has been well received among participants 
without concerns or complaints. Subjects will be enrolled at the time of admission to 
labor and delivery (L&D) for delivery or thereafter. Once the inclusion criteria for our 
study are met, the clinical team will inform the subject about the study and ask her 
authorization to contact one of the study personnel. 
 
Consenting process: Written consent will be obtained by direct person-to-person 
contact. The research staff will be responsible for the informed consent. For non-
English speaking subjects, informed consent will be provided in their primary language. 
The research data collected will not be used for clinical diagnosis or treatment 
purposes. Subjects will be reassured that participation in the study is voluntary and will 
not interfere with diagnose or treatment of her condition. The subjects will receive the 
same care and expertise as any other patient treated in our unit. 
 
4.2 Randomization  
A confidential computer-generated simple randomization scheme will be prepared and 
provided on an ongoing basis to our research staff. A randomization log with group 
assignment, patient name and medical record number will be used to track the 
randomization process.   
 
4.3. Study visits/Follow-up 
A single maternal follow-up study visit will be scheduled to ascertain/confirm 
outcomes at the same time as the routine clinical visit (~7 days postoperative). This 
visit is the standard postpartum visit at UTMB for a wound check. The standard 
procedure in our postpartum care unit is that the providers will schedule the 
postpartum visit before the patient leaves the hospital. Our research staff will 
document the time and date of the postpartum appointment in the datasheet, in order 
to ascertain follow up. The subject will be informed of the appointment and will be 
given a phone number for any questions and concerns regarding the study (contact 
information will be in the consents). We will also collect a provider satisfaction 

 
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questionnaire (Appendix A) from the provider/clinical staff that took care of the 
subject during her hospital stay. Subject’s participation will end 30 days after delivery. 
 
At the visit, the research staff or trained provider will give the quality of life (QoL) and 
satisfaction survey to the patient (Appendix B). We will also review the electronic 
medical record for the relevant outcomes. We will have research staff at every 
obstetrical clinic available during regular hours. If the subject does not present at this 
visit, or the survey was not completed during the visit, every effort will be made to 
contact her by phone and outcomes further ascertained. If greater than 30 post-
operative days have passed and the subject could not be reached, she will be 
designated as “lost to follow-up.” 
 
4.4. Baseline Procedures 
Routine post-cesarean care will be according to the subjects’ clinical providers.  
Trained and experienced research staff will be responsible for all research data 
abstraction. The PI will review and validate the data. Data on these forms devoid of 
personal identifiers will be securely stored in our perinatal research division offices. 
 
4.5. Withdrawals 
Subjects who withdraw from the study after randomization will be excluded from 
further follow-up. Outcomes will be reported by intent to treat fashion. Those who 
withdraw prior to ascertaining of the primary outcome and refuse further data 
collection will be accounted for by randomizing an equal number of additional subjects 
and will not be included in the analysis. 

 
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Study Summary Flow Diagram 
Assessed for eligibility  
Excluded 
Not meeting inclusion criteria 
Meeting exclusion criteria 
Declined to participate  
Other reasons  
The PI/research staff will review and validate 
the data. 
~7 days standard postpartum visit at UTMB. If 
the subject does not present within the 30 day 
window, or survey was not completed during 
the planned visit, every effort will be made to 
contact the woman by phone and outcomes 
further ascertained  
Standard Wound Care 
~7 days standard postpartum visit at UTMB. If 
the subject does not present within the 30 day 
window, or survey was not completed during 
the planned visit, every effort will be made to 
contact the woman by phone and outcomes 
further ascertained  
CHG Wound Care 
The PI/ research staff will review and validate 
the data. 
 
Allocation 
Analysis 
Follow-Up 
Randomized 
Enrollment on L&D 

 
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4.6. Primary Outcome 
Satisfaction and QoL questionnaire. 
 
4.7. Secondary Outcomes 
• Composite wound complication. 
o Defined as presence of any of the following within 30 days from 
surgery: Wound infection: Presence of either superficial or deep 
incisional SSI described as cellulitis/erythema and induration around 
the incision or purulent discharge from the incision site, with or without 
fever, such as necrotizing fasciitis (diagnosed based on necrotizing 
wound infection).  Wound hematoma, seroma, or breakdown alone. 
• Endometritis, wound infection (including necrotizing fasciitis), other infections 
including abscess, septic thrombosis, pneumonia, pyelonephritis and breast 
infection. 
• Maternal Death. 
• Puerperal fever: Temperature > 100.4oF after first 24 hours or ≥101oF any time. 
• Postpartum antibiotic use. 
• Wound hematoma or seroma. 
• Wound dehiscence. 
• Use of resources: hospital stay, postpartum clinic or emergency room visit within 
30 days of delivery, need for imaging or other invasive procedures. 
• Adverse events: allergic reactions (anaphylaxis, angioedema, skin rashes 
including Stevens Johnson and Toxic Epidermal Necrolysis). 
• Provider satisfaction survey. 
 
5. Inclusion Criteria: 
• 18-50 years of age. 
• Women ≥ 24 weeks’ viable gestation. 
• To undergo cesarean delivery. 
• Admission BMI ≥ 35. 
 
6. Exclusion Criteria: 
• Patient unwilling or unable to provide consent. 
• No prenatal care or a non-resident patient who is unlikely to be followed-up 
after delivery. 

 
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• Immunosuppressed subjects: i.e., taking systemic immunosuppressant or 
steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV 
with CD4 <200, or other. 
• Decision not to have skin closure (e.g. secondary wound closure, mesh closure). 
• Current skin infection. 
• Coagulopathy. 
• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled 
hysterectomy, bowel or adnexal surgery). 
• Known allergy to CHG. 
• Incarcerated individuals. 
• Chorioamnionitis. 
 
7. Sources of Research Material: Electronic Medical chart/records; questionnaires. 
 
8. Potential Risks: 
8.1. Randomization risk 
Since wound dressing care will be randomized, it is possible that the patient may be in 
a group with higher adverse outcomes. 
 
8.2. Loss of Confidentiality 
Any time information is collected, there is a potential risk for loss of confidentiality.  
Every effort will be made to keep patient’s information confidential; however, this 
cannot be guaranteed. 
 
8.3. Allergic reaction to CHG (Very rare, unreported but possible) 
Subjects receiving a CHG wound dressing may have the following bad effects: 
Allergic reaction. 
 
9. Subject Safety and Data Monitoring 
The PI and research staff will be responsible for monitoring the safety of this study. A 
report to the IRB will be submitted according to its policy if adverse events (AEs) or 
serious adverse events (SAEs) occur, and any changes in the protocol as a result of 
these events. No interim analysis will be planned and there will be no study-specific 
criteria to halt the study. Since, CHG Wound dressings are deemed safe and available 
for use according to the FDA, there are no safety and minimal toxicity concerns for 
patient withdrawal. 
The research staff will ensure all aspects of data quality including monitoring for 
adherence to consent procedures, inclusion and exclusion criteria, valid abstraction, 
correct entry, timeliness and responsiveness to data queries.  

 
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Data collection will take the form of excel data entry and will be identified with a 
participant ID number. Data will be collected and stored with the participant ID code 
only. The master enrollment log linking patient identifiers with study ID numbers will 
be kept in a password-protected database on the Ob/Gyn Department’s internal server 
separate from the data. Several data collection forms will be used. Data on these forms 
devoid of personal identifiers will be securely stored at our perinatal research division. 
The research staff will be available to monitor the data and correct any discrepancies 
based on source documents if needed. 
 
10. Procedures to Maintain Confidentiality 
Each patient will be assigned a study number with personal identifiable information 
deleted or removed. Subjects' information will be de-identified and tagged with a 
number. Data will be collected and stored on a UTMB password-protected computer in 
a locked room. 
 
11. Potential Benefits 
A potential benefit is that the CHG impregnated dressing leads to better patient 
satisfaction and quality of life. We also hope that this dressing will ultimately reduce 
SSI rates and maternal health costs.  
 
12. Statistical Approach 
In preparation for sample size calculation, and following IRB exemption, ~20 patients 
with standard wound care filled the satisfaction and QoL surveys. The total mean score 
was 46 with a standard deviation of 9.1. Using effect sizes of 10%, power of 90% and 2-
sided alpha of 0.05, we estimate that we will need 144 with complete ascertainment. 
Assuming a 10% loss to follow, we propose to enroll a total of 160 patients. Analyses 
will be performed by intent to treat. We will be using STATA 15 (Dallas, TX) for 
statistical computations. We will be also doing an analysis of the questionnaire using 
the Cochran-Armitage test for trend. P<0.05 was considered significant.This trial will be 
registered with Clinical Trials Register (Clinicaltrials.gov), before recruitment is initiated 
and after IRB approval. 
 
 
 

 
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