Surgical Wound InfectionNCT01741649
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
A study testing Clorhexidine and Povidone in people with Surgical Wound Infection, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Clorhexidine and Povidone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 sitePanama
- Study dates
- Oct 2012to Apr 2013
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age > 32 weeks
- Emergency cesarean section
Who cannot join
- Allergy to clorhexidine
- Allergy to povidone
- Evidence of infection in the surgical site
- Loss to follow up at 15 days
- Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.
- Conditions
- Surgical Wound Infection
- Being tested
- Clorhexidine, Povidone
- Keywords
- Surgical wound infection, Clorhexidine, Povidone
- 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.
ClorhexidineProcedure or surgery
Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
PovidoneProcedure or surgery
Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Clorhexidine | Experimental | Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine. Receives: Procedure: Clorhexidine |
| Povidone | Experimental | Skin prior to surgical incision will be cleaned for five minutes with a povidine solution. Receives: Procedure: Povidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection (SSI)
The patients will be evaluated for evidence of surgical site infection before leaving the hospital, three (3) days after surgery. The presence of fever, suppurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be classified in accordance as "With SSI" or "Without SSI".
Measured: 3 days
Secondary outcomes (1)
Hospitalization
The patients will be evaluated for evidence of surgical site infection 15 days post surgery. The need to admit the patient to the hospital for management of a surgical site infection will be classified with "Hospitalization - Yes/No".
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741649
- Sponsor's protocol ID
- MHST2012-04
- Status last verified
- May 2013
- First submitted
- 1 Dec 2012
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01741649
- Acronym / sponsor ID
- MHST2012-04
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical wound infection, Clorhexidine, Povidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Dec 2012 (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.
Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clorhexidine | Experimental | Procedure: ClorhexidineSkin prior to the surgical incision will be cleaned for five minutes with Clorhexidine. |
| Povidone | Experimental | Procedure: PovidoneSkin prior to surgical incision will be cleaned for five minutes with a povidine solution. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age > 32 weeks
- Emergency cesarean section
Key exclusion criteria (5 listed)
- Allergy to clorhexidine
- Allergy to povidone
- Evidence of infection in the surgical site
- Loss to follow up at 15 days
- Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.
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 |
|---|---|---|
| ClorhexidineCleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes. | Procedure or surgery | Clorhexidine |
| PovidoneCleaning of the surgical site previous to the incision with a povidone solution for five minutes. | Procedure or surgery | Povidone |
Primary outcome
Surgical Site infection (SSI)
Time frame: 3 days
The patients will be evaluated for evidence of surgical site infection before leaving the hospital, three (3) days after surgery. The presence of fever, suppurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be classified in accordance as "With SSI" or "Without SSI".
1 secondary outcome
Hospitalization
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clorhexidine and Povidone in people with Surgical Wound Infection, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 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: finished, as of the sponsor's last update on 17 May 2013. 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 Panama. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical Site infection (SSI) (time frame: 3 days). 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 17 May 2013.