Wound InfectionsPhase 3NCT01700803
Povidone Iodine and Cesarean Section Wound Infections
A Phase 3 study testing Povidone Iodine 10% vand cesarean section wound infections and Povidone Iodine 7.5% vand cesarean section wound infections in people with Wound Infections, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Wound Infections
- What is being tested?
- Povidone Iodine 10% vand cesarean section wound infections and Povidone Iodine 7.5% vand cesarean section wound infections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,231 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to May 2012
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- elective caesarian section (CS)
Who cannot join
- diabetes,
- immuno-compromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents.
Read the detailed description
For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.
There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol \& triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect \& fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk \& proven its efficiency.
- Conditions
- Wound Infections
- Being tested
- Povidone Iodine 10% vand cesarean section wound infections, Povidone Iodine 7.5% vand cesarean section wound infections
- Keywords
- Betadine, Povidine Iodine, Hand scrubbing, Cesarean section wound infections, post cesarean section
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone Iodine 10% vand cesarean section wound infectionsDrug
Povidone Iodine 7.5% vand cesarean section wound infectionsDrug
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine 10% | Experimental | Using Povidone Iodine 10% hand scrub before caesarian section Receives: Drug: Povidone Iodine 10% vand cesarean section wound infections |
| Povidone Iodine 7.5% hand scrub | Experimental | Using Povidone Iodine 7.5% hand scrub before caesarian section Receives: Drug: Povidone Iodine 7.5% vand cesarean section wound infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of incidence of surgical site infection between both groups
Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub
Measured: 4 month
Secondary outcomes (1)
The difference in the side effects between both groups e.g. dermatitis
Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700803
- Sponsor's protocol ID
- Betadine CS
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01700803
- Acronym / sponsor ID
- Betadine CS
- Conditions
- Wound Infections
- Keywords
- Betadine, Povidine Iodine, Hand scrubbing, Cesarean section wound infections, post cesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,231 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Oct 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.
The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents.
Detailed description
For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.
There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol \& triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect \& fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk \& proven its efficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine 10% | Experimental | Drug: Povidone Iodine 10% vand cesarean section wound infectionsUsing Povidone Iodine 10% hand scrub before caesarian section |
| Povidone Iodine 7.5% hand scrub | Experimental | Drug: Povidone Iodine 7.5% vand cesarean section wound infectionsUsing Povidone Iodine 7.5% hand scrub before caesarian section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective caesarian section (CS)
Key exclusion criteria (2 listed)
- diabetes,
- immuno-compromised patients
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 10% vand cesarean section wound infections | Drug | Povidone Iodine 10% |
| Povidone Iodine 7.5% vand cesarean section wound infections | Drug | Povidone Iodine 7.5% hand scrub |
Primary outcome
The difference of incidence of surgical site infection between both groups
Time frame: 4 month
Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub
1 secondary outcome
The difference in the side effects between both groups e.g. dermatitis
Time frame: 4 month
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 4 Oct 2012.
Related trials for Wound Infections
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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 Phase 3 study testing Povidone Iodine 10% vand cesarean section wound infections and Povidone Iodine 7.5% vand cesarean section wound infections in people with Wound Infections, run by Assiut University 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 1 inclusion and 2 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 4 Oct 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 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 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 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?
The difference of incidence of surgical site infection between both groups (time frame: 4 month). 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 4 Oct 2012.