Surgical Site InfectionPhase 2NCT02396329
Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection
A Phase 2 study testing Chlorhexidine and Povidone-Iodine in people with Surgical Site Infection, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Chlorhexidine and Povidone-Iodine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
- Body mass index (BMI) between 20-35kg/m2.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
Who cannot join
- Rupture of membranes.
- Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
- Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo, 11566
AMR YEHIA, MD, MRCOG, +201227900014, am_helmy77@hotmail.com
About this study
Official title: Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial
There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.
Read the detailed description
The aim of this study is to examine the efficacy \&safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption.
Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.
- Conditions
- Surgical Site Infection
- Being tested
- Chlorhexidine, Povidone-Iodine
- 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.
ChlorhexidineDrug
Povidone-IodineDrug
Also called Betadine
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine _based antisepsis | Experimental | Including cases undergoing elective\&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision.
. Receives: Drug: Chlorhexidine |
| povidone_iodine based antisepsis | Active comparator | Including cases undergoing elective\&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision Receives: Drug: Povidone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection within one week after surgery
Measured: One week
Secondary outcomes (4)
Surgical site infection within 30 days after surgery
Measured: in 30 days
Long hospital stay
hospital admission for more than 5 days
Measured: 30 days
Hospital readmission
readmission due to sepsis
Measured: 30 days
Febrile morbidity
an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
- Investigators
- AMR YEHIA, MD, MRCOG, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396329
- Sponsor's protocol ID
- antisepsis 1
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32580252
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02396329
- Acronym / sponsor ID
- antisepsis 1
- Conditions
- Surgical Site Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.
Detailed description
The aim of this study is to examine the efficacy \&safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption.
Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine _based antisepsis | Experimental | Drug: ChlorhexidineIncluding cases undergoing elective\&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision. . |
| povidone_iodine based antisepsis | Active comparator | Drug: Povidone-IodineIncluding cases undergoing elective\&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
- Body mass index (BMI) between 20-35kg/m2.
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
Key exclusion criteria (3 listed)
- Rupture of membranes.
- Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
- Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.
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 |
|---|---|---|
| Chlorhexidine | Drug | chlorhexidine _based antisepsis |
| Povidone-IodineAlso: Betadine | Drug | povidone_iodine based antisepsis |
Primary outcome
Surgical site infection within one week after surgery
Time frame: One week
4 secondary outcomes
Surgical site infection within 30 days after surgery
Time frame: in 30 days
Long hospital stay
Time frame: 30 days
Hospital readmission
Time frame: 30 days
Febrile morbidity
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- 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.
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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.
AMR YEHIA, MD, MRCOG study director
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine and Povidone-Iodine in people with Surgical Site Infection, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AMR YEHIA, MD, MRCOG (+201227900014, am_helmy77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection within one week after surgery (time frame: One week). 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 NCT02396329, which also lists 1 linked publication.
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 24 Mar 2015.