Wound InfectionPhase 3NCT00528008
A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
A Phase 3 study testing povidone-iodine solution and chlorhexidine gluconate in people with Wound Infection, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Infection
- What is being tested?
- povidone-iodine solution and chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Feb 2010
- Phase
- Phase 3
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >19 years
- Gestational age > 37 weeks
- Booked elective cesarean section
Who cannot join
- Gestational age < 37 weeks
- Premature rupture of membranes
- Onset of labor prior to procedure
- Evidence of maternal sepsis; maternal fever > 38.5C
- LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women' s Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, A1E 5K9
About this study
Official title: Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.
Read the detailed description
Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.
- Conditions
- Wound Infection
- Being tested
- povidone-iodine solution, chlorhexidine gluconate
- Keywords
- infection, sepsis, povidone-iodine, chlorhexidine gluconate, fever, erythema, leukocytosis, drainage, vaginal discharge, elective cesarean section
- Medical subject headings
- Wound Infection, Infections, Sepsis, Fever, Erythema, Leukocytosis, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
povidone-iodine solutionOther
Also called Betadine, Povidone, Minidyne
Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.
chlorhexidine gluconateOther
Also called Dexidine, Avagard, Bactoshield
Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | povidone-iodine Receives: Other: povidone-iodine solution |
| B | Active comparator | chlorhexidine gluconate Receives: Other: chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate
Measured: within 6 weeks following surgery
Secondary outcomes (5)
readmission to hospital
Measured: within 6 weeks following surgery
extended length of admission
Measured: within 6 weeks following surgery
need for intravenous antibiotics
Measured: within 6 weeks following surgery
need for repeat procedure such as drainage
Measured: within 6 weeks following surgery
increased outpatient surveillance
Measured: within 6 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Study was stopped following interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health
- Responsible party
- Sponsor
- Investigators
- Paula Mallaley, MD, Principal investigator, Resident, Obstetrics and Gynecology, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528008
- Sponsor's protocol ID
- HIC07.33
- Status last verified
- Nov 2012
- First submitted
- 10 Sep 2007
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
- ClinicalTrials.gov ID
- NCT00528008
- Acronym / sponsor ID
- HIC07.33
- Conditions
- Wound Infection
- Keywords
- infection, sepsis, povidone-iodine, chlorhexidine gluconate, fever, erythema, leukocytosis, drainage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped following interim analysis.
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Eastern Health
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Sep 2007 (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.
The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.
Detailed description
Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: povidone-iodine solutionpovidone-iodine |
| B | Active comparator | Other: chlorhexidine gluconatechlorhexidine gluconate |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >19 years
- Gestational age > 37 weeks
- Booked elective cesarean section
Key exclusion criteria (5 listed)
- Gestational age < 37 weeks
- Premature rupture of membranes
- Onset of labor prior to procedure
- Evidence of maternal sepsis; maternal fever > 38.5C
- LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction
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 |
|---|---|---|
| povidone-iodine solutionAlso: Betadine, Povidone, MinidyneAbdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution. | Other | A |
| chlorhexidine gluconateAlso: Dexidine, Avagard, BactoshieldAbdominal surgical field painted once using 2% chlorhexidine in 70% alcohol. | Other | B |
Primary outcome
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate
Time frame: within 6 weeks following surgery
5 secondary outcomes
readmission to hospital
Time frame: within 6 weeks following surgery
extended length of admission
Time frame: within 6 weeks following surgery
need for intravenous antibiotics
Time frame: within 6 weeks following surgery
need for repeat procedure such as drainage
Time frame: within 6 weeks following surgery
increased outpatient surveillance
Time frame: within 6 weeks following surgery
Results and safety
The study was stopped early (reason given: Study was stopped following interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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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.
Paula Mallaley, MD principal investigator
Resident, Obstetrics and Gynecology, Memorial University of Newfoundland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing povidone-iodine solution and chlorhexidine gluconate in people with Wound Infection, run by Memorial University of Newfoundland at 1 site in Canada.
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 5 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: stopped early, as of the sponsor's last update on 9 Nov 2012. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was stopped following interim analysis.). Results are not available in the source record.
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?
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate (time frame: within 6 weeks following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2012.