Surgical Site Infection Following Cesarean DeliveryNCT01870583
Comparison of Surgical Skin Preps During Cesarean Deliveries
A study testing Iodine povidone, Chlorhexidine and Combination iodine and chlorhexidine in people with Surgical Site Infection Following Cesarean Delivery, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Surgical Site Infection Following Cesarean Delivery
- What is being tested?
- Iodine povidone, Chlorhexidine and Combination iodine and chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,404 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age > 37 weeks 0/7 days
- Non-emergency indication for cesarean
Who cannot join
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery
- Participation in another research study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Medical Center Weiler Division
The Bronx, New York, 10461
Montefiore Medical Center Wakefield Division
The Bronx, New York, 10466
About this study
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.
Read the detailed description
Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.
The purpose of the study is:
- To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
- To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.
This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.
The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.
Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.
All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.
- Being tested
- Iodine povidone, Chlorhexidine, Combination iodine and chlorhexidine
- Keywords
- Cesarean delivery, Surgical site infection, Pregnancy, Postpartum
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine povidoneDrug
Iodine skin preparation solution prior to cesarean delivery
ChlorhexidineDrug
Chlorhexidine skin preparation solution prior to cesarean delivery
Combination iodine and chlorhexidineDrug
Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Combination iodine and chlorhexidine | Active comparator | The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Receives: Drug: Combination iodine and chlorhexidine |
| Chlorhexidine | Active comparator | Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Receives: Drug: Chlorhexidine |
| Iodine povidone | Active comparator | Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Receives: Drug: Iodine povidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Surgical Site Infection
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
Measured: 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection Following Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Garry, Montefiore Medical Center
- Investigators
- David A Wallach, CIP, Study chair, Einstein IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870583
- Sponsor's protocol ID
- CCI#12-07-248
- Status last verified
- Sep 2017
- First submitted
- 3 Jun 2013
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zinn J, Jenkins JB, Harrelson B, Wrenn C, Haynes E, Small N. Differences in intraoperative prep solutions: a retrospective chart review. AORN J. 2013 May;97(5):552-8. doi: 10.1016/j.aorn.2013.03.006.
PubMed 23622828Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.
PubMed 7040461Stinner DJ, Krueger CA, Masini BD, Wenke JC. Time-dependent effect of chlorhexidine surgical prep. J Hosp Infect. 2011 Dec;79(4):313-6. doi: 10.1016/j.jhin.2011.08.016. Epub 2011 Oct 15.
PubMed 22000737Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755.
PubMed 20102279Gong SP, Guo HX, Zhou HZ, Chen L, Yu YH. Morbidity and risk factors for surgical site infection following cesarean section in Guangdong Province, China. J Obstet Gynaecol Res. 2012 Mar;38(3):509-15. doi: 10.1111/j.1447-0756.2011.01746.x. Epub 2012 Feb 22.
PubMed 22353388Miner AL, Sands KE, Yokoe DS, Freedman J, Thompson K, Livingston JM, Platt R. Enhanced identification of postoperative infections among outpatients. Emerg Infect Dis. 2004 Nov;10(11):1931-7. doi: 10.3201/eid1011.040784.
PubMed 15550202Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.
PubMed 17712651Lobdell KW, Stamou S, Sanchez JA. Hospital-acquired infections. Surg Clin North Am. 2012 Feb;92(1):65-77. doi: 10.1016/j.suc.2011.11.003. Epub 2011 Dec 5.
PubMed 22269261Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.
PubMed 12463081Hadiati 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.
PubMed 32580252Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.
PubMed 26551196
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Skin Preps During Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT01870583
- Acronym / sponsor ID
- CCI#12-07-248
- Keywords
- Cesarean delivery, Surgical site infection, Pregnancy, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,404 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 19 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.
Detailed description
Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.
The purpose of the study is:
- To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
- To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.
This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.
The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.
Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.
All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination iodine and chlorhexidine | Active comparator | Drug: Combination iodine and chlorhexidineThe combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. |
| Chlorhexidine | Active comparator | Drug: ChlorhexidineChlorhexidine based skin preparation solution applied to skin prior to cesarean delivery |
| Iodine povidone | Active comparator | Drug: Iodine povidoneIodine povidone based skin preparation solution applied to skin prior to cesarean delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational age > 37 weeks 0/7 days
- Non-emergency indication for cesarean
Key exclusion criteria (4 listed)
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery
- Participation in another research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine povidoneIodine skin preparation solution prior to cesarean delivery | Drug | Iodine povidone |
| ChlorhexidineChlorhexidine skin preparation solution prior to cesarean delivery | Drug | Chlorhexidine |
| Combination iodine and chlorhexidineCombination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery | Drug | Combination iodine and chlorhexidine |
Primary outcome
Cesarean Surgical Site Infection
Time frame: 42 days after delivery
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23622828Zinn J, Jenkins JB, Harrelson B, Wrenn C, Haynes E, Small N. Differences in intraoperative prep solutions: a retrospective chart review. AORN J. 2013 May;97(5):552-8. doi: 10.1016/j.aorn.2013.03.006.
- Background: PubMed 7040461Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.
- Background: PubMed 22000737Stinner DJ, Krueger CA, Masini BD, Wenke JC. Time-dependent effect of chlorhexidine surgical prep. J Hosp Infect. 2011 Dec;79(4):313-6. doi: 10.1016/j.jhin.2011.08.016. Epub 2011 Oct 15.
- Background: PubMed 20102279Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755.
- Background: PubMed 22353388Gong SP, Guo HX, Zhou HZ, Chen L, Yu YH. Morbidity and risk factors for surgical site infection following cesarean section in Guangdong Province, China. J Obstet Gynaecol Res. 2012 Mar;38(3):509-15. doi: 10.1111/j.1447-0756.2011.01746.x. Epub 2012 Feb 22.
- Background: PubMed 15550202Miner AL, Sands KE, Yokoe DS, Freedman J, Thompson K, Livingston JM, Platt R. Enhanced identification of postoperative infections among outpatients. Emerg Infect Dis. 2004 Nov;10(11):1931-7. doi: 10.3201/eid1011.040784.
- Background: PubMed 17712651Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.
- Background: PubMed 22269261Lobdell KW, Stamou S, Sanchez JA. Hospital-acquired infections. Surg Clin North Am. 2012 Feb;92(1):65-77. doi: 10.1016/j.suc.2011.11.003. Epub 2011 Dec 5.
- Background: PubMed 12463081Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.
- Derived from this study: PubMed 32580252Hadiati 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.
- Derived from this study: PubMed 26551196Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.
Related trials for Surgical Site Infection Following Cesarean Delivery
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section
Surgical Site Infection
Enrolling by invitation
Evaluation of an mHealth-CHW Tool for Post-c-section Follow-up in Rural Rwanda
Surgical Site Infection Following Cesarean Delivery, Cesarean Section Complications
Recruiting
Skin Adhesive Plus Intra-cuticular Suture Versus Suture Alone for Cesarean Skin Closure
Surgical Site Infection (SSI)
Not yet recruitingObservational study
Incidence of Ssi After c.s
Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Wallach, CIP study chair
Einstein IRB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine povidone, Chlorhexidine and Combination iodine and chlorhexidine in people with Surgical Site Infection Following Cesarean Delivery, run by Montefiore Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Surgical Site Infection (time frame: 42 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01870583, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.