Incidence of cs Scar InfectionPhase 2NCT03725748
Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section
A Phase 2 study testing irrigation in people with Incidence of cs Scar Infection, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section. Read more about this study
- Who is it for?
- Ages 19 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incidence of cs Scar Infection
- What is being tested?
- irrigation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to Jun 2019
- 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 19 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects candidate for the study will be 37 weeks' gestation
- require a cesarean section (elective or emergency).
Who cannot join
- Patients with allergy to iodine
- history of immunosuppressive drug use,
- gestationaldiabetes mellitus
- preeclampsia
- anemic patients
- ruptured of membranes
- feverish patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr El Ainy
Cairo, 02
mohamed saad, lecturer, 01244336666, msaad@scimitar.com
About this study
Official title: Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.
Read the detailed description
This study will be conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.
We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.
Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.
The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.
- Conditions
- Incidence of cs Scar Infection
- Being tested
- irrigation
- Keywords
- saline, betadine, cesarean scar infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irrigationOther
irrigation the edges of the cs scar before closure
| Study group | Role | What they receive |
|---|---|---|
| no irrigation group | No intervention | nothing used for irrigation of cs scar |
| saline irrigation group | Placebo comparator | saline used for irrigation the cs scar before closure Receives: Other: irrigation |
| betadine irrigation group | Experimental | betadine used for irrigation of cs scar Receives: Other: irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cs scar infection
incidence of cs scar infection
Measured: 2 to 6 weeks
Secondary outcomes (1)
incidence of hematoma, seroma
incidence of hematoma, seroma, wound breakdown
Measured: 2 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of cs Scar 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeer meshal, Kasr El Aini Hospital
- Investigators
- fady salah, lecturer, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725748
- Sponsor's protocol ID
- assistant professor2
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
- ClinicalTrials.gov ID
- NCT03725748
- Acronym / sponsor ID
- assistant professor2
- Conditions
- Incidence of cs Scar Infection
- Keywords
- saline, betadine, cesarean scar infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 31 Oct 2018 (actual)
- 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.
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.
Detailed description
This study will be conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.
We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.
Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.
The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no irrigation group | No intervention | –nothing used for irrigation of cs scar |
| saline irrigation group | Placebo comparator | Other: irrigationsaline used for irrigation the cs scar before closure |
| betadine irrigation group | Experimental | Other: irrigationbetadine used for irrigation of cs scar |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects candidate for the study will be 37 weeks' gestation
- require a cesarean section (elective or emergency).
Key exclusion criteria (7 listed)
- Patients with allergy to iodine
- history of immunosuppressive drug use,
- gestationaldiabetes mellitus
- preeclampsia
- anemic 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 |
|---|---|---|
| irrigationirrigation the edges of the cs scar before closure | Other | betadine irrigation group, saline irrigation group |
Primary outcome
incidence of cs scar infection
Time frame: 2 to 6 weeks
incidence of cs scar infection
1 secondary outcome
incidence of hematoma, seroma
Time frame: 2 to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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.
fady salah, lecturer study director
Director
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 irrigation in people with Incidence of cs Scar Infection, run by Kasr El Aini 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 2 inclusion and 7 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 31 Oct 2018. 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. Some participants in this study may receive a placebo. 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 hany saad, assistant prof (01001817211, dr_hanysaad@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of cs scar infection (time frame: 2 to 6 weeks). 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 31 Oct 2018.