Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.
Patients who are considered likely to need cesarean delivery or who are planning cesarean will be recruited and consented for study participation during prenatal care and/or at time of admission to labor and delivery.
Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2. Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting surgeon (listed as key personnel) after the patient has arrived into the operating room for cesarean. Pre-operative surgical site antisepsis will be performed according to randomization. All other surgical practices will remain at the surgeon's discretion according to standard of care at Metrohealth.
Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of surgical site infection, as standard in the investigators institution. The chart will be reviewed to determine if the patient was diagnosed during admission, or, re-admitted because of surgical site infection. The patient will also be questioned regarding any treatment or diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the routine six week post-operative visit. If patient does not return for the routine post-operative visit, the investigator will attempt to contact the patient by telephone to determine if the patient had been diagnosed or treated for surgical site infection. If patient is lost to 6 week follow up, subanalysis will be performed on available data derived from hospitalization and hospital Electronic Medical Record (EMR).
Data will be captured in RedCAP database.
Additional data will be captured that may affect patient likelihood of surgical site infection to ensure that both groups are statistically equal in risk factors for SSI: labor or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes, estimated blood loss, operative time, race, insurance type, general versus regional anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).
Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50% reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans are performed at the investigators institution per year and the investigators anticipate that 80% will be eligible to participate.
Data review will be done every 6 months or every 200 patients and analyzed, whichever is sooner. Analysis will be performed by the Primary Investigators (PI) for completeness, accuracy, strict adherence to study protocol, safety, and statistical significance. The investigators site is also subject to periodic audits by the investigators Institutional Review Board (IRB).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine - Isopropyl alcohol | Experimental | Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol |
|
| Povidone-Iodine Scrub and Paint | Experimental | Pre-operative skin preparation with Povidone-Iodine Scrub and Paint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine - Isopropyl alcohol | Drug | Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Surgical Site Infection | Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space. | 4 weeks after cesarean delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Non-infections Surgical Site Complications | Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence. | 4 weeks after cesarean delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian B Mercer, MD | MetroHealth Medical Center/Case Western Reserve | Principal Investigator |
| Edward H Springel, MD | MetroHealth Medical Center/Case Western Reserve | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109-1998 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20054046 | Background | Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. | |
| 32580252 | Derived | Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment and randomization began March 2014 and was successfully completed May 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine - Isopropyl Alcohol | Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
| FG001 | Povidone-Iodine Scrub and Paint | Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine - Isopropyl Alcohol | Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
| BG001 | Povidone-Iodine Scrub and Paint |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Surgical Site Infection | Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space. | Posted | Count of Participants | Participants | 4 weeks after cesarean delivery |
|
4 weeks
Adverse event data was collected at the same time as primary outcome data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine - Isopropyl Alcohol | Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
Not provided
Not provided
Lack of masking of clinical personnel to treatment assignment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward H Springel, MD | Virginia Commonwealth University Health System | 804-828-8468 | edward.springel@vcuhealth.org |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| D010150 | Paint |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Povidone-Iodine Scrub and Paint | Drug | Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
|
|
| 28599898 | Derived | Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7. |
Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Patients With Non-infections Surgical Site Complications | Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence. | Posted | Count of Participants | Participants | 4 weeks after cesarean delivery |
|
|
|
| 0 |
| 461 |
| 0 |
| 461 |
| 0 |
| 461 |
| EG001 | Povidone-Iodine Scrub and Paint | Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA | 0 | 471 | 0 | 471 | 0 | 471 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |