Surgical Site InfectionNCT06595823
Betadine Versus Saline in Swapping of Subcutaneous Tissue
A study testing Betadine in people with Surgical Site Infection, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Betadine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to 10 Mar 2023
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary Elective Cs .
- Age: 20 - 35 years old,
- elective caesarean section time from skin incision to skin closure less than 60 minute,
- Body Mass Index: 20- 30 Kg/m2.
Who cannot join
- Diabetes mellitus,
- feverish patient,
- patient using steroids for chronic illness,
- prelabour rupture of membrane,
- difference in pre and postoperative hemoglobin more than 10%,
- Patients with coagulopathies,
- mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Betadine Versus Saline in Swapping of Subcutaneous Tissue to Prevent Surgical Site Infection After Caesarian Section
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported. The risk of maternal morbidity and mortality is higher in caesarean section than in vaginal birth; postoperative infection is a common component of morbidity. With the increase in caesarean section, it is important that the risks to the mother are minimized as far as possible.
Women who give birth by caesarean section are exposed to both endogenous (internal) and exogenous (external) sources of infection during birth. Exposure to a hospital environment places these women at risk of developing hospital-acquired infections. The rate of post-caesarean infection has been estimated to be 10 times greater than that after vaginal birth.
Read the detailed description
The Centers for Disease Control and Prevention (CDC) estimates that 27 million surgical procedures are performed in the United States each year. The CDC's National Nosocomial Infections Surveillance system reports that surgical site infections are the third most frequently reported nosocomial infection, accounting for 14% to 16% of all such infections.
Preventing infection by properly preparing the skin before incision is thus a vital part of the overall care given to women during caesarean birth. The incidence of abdominal incisional infections following caesarean section ranges from 3% to 15%.A post-caesarean surgical site infection is a bacterial infection in the surgical incision following an abdominal birth. Women who develop a post-caesarean surgical site infection typically experience a temperature of 38.0°C (100.4°F) or higher and lower abdominal pain. Abdominal incisional abscesses that develop following caesarean birth usually cause fever on about the fourth postoperative day.
In many cases, these are preceded by uterine infection, and fever persists from the first or second postoperative day. Wound redness (erythema) and drainage may also be present. Organisms causing these infections are usually the same as those isolated from amniotic fluid at caesarean birth, but hospital-acquired pathogens may also be the cause. Some women are more likely than others to develop a post-caesarean surgical site infection.Women at increased risk include those who are obese; have diabetes or an immunosuppressive disorder (HIV infection); have chorioamnionitis (infection of the amniotic fluid and fetal membrane) during labor; anemia; or are taking corticosteroids.
Proper preparation of an incision site involves removing surface dirt and oil with a soap or detergent scrub plus applying a topical antimicrobial agent that will reduce the bacterial population to a minimal level.If prophylactic antimicrobials are given, the incidence of abdominal wound infection following cesarean delivery ranges from 2 to 10 percent depending on risk factors. Numerous good quality trials have proved that a single dose of an antimicrobial agent given at the time of cesarean delivery significantly decreases infection morbidity.
- Conditions
- Surgical Site Infection
- Being tested
- Betadine
- 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.
BetadineDrug
Also called Saline
To compare between Betadine (10%) and saline (0.9%) in swapping of subcutaneous tissue for prevention of surgical site infection after primary elective caesarian section.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Povidone-Iodine10%) | Active comparator | About 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 10% solution. Receives: Drug: Betadine |
| Group B (Saline0.9%) | Active comparator | About 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with normal saline0.9% Receives: Drug: Betadine |
| Group C (the control group) | Placebo comparator | About 100 patients women who underwent elective caesarian section without irrigation of the subcutaneous tissue with betadine or saline. Receives: Drug: Betadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of surgical site infections
Assessment of Number of Participants With Treatment of surgical site infections using Povidine Iodine or by using saline and which one is effective in Treatment
Measured: 6 weeks after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Mar 2022
- Primary completion5 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Ahmed Abd El Hameed Ahmed, Professor, Study chair, Obstetrics and Gynecology Department, Faculty of medicine, Al-Azhar University, Assuit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595823
- Sponsor's protocol ID
- Asmaa Gamal Mohamed
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betadine Versus Saline in Swapping of Subcutaneous Tissue to Prevent Surgical Site Infection After Caesarian Section
- ClinicalTrials.gov ID
- NCT06595823
- Acronym / sponsor ID
- Asmaa Gamal Mohamed
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 19 Sep 2024 (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.
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported. The risk of maternal morbidity and mortality is higher in caesarean section than in vaginal birth; postoperative infection is a common component of morbidity. With the increase in caesarean section, it is important that the risks to the mother are minimized as far as possible.
Women who give birth by caesarean section are exposed to both endogenous (internal) and exogenous (external) sources of infection during birth. Exposure to a hospital environment places these women at risk of developing hospital-acquired infections. The rate of post-caesarean infection has been estimated to be 10 times greater than that after vaginal birth.
Detailed description
The Centers for Disease Control and Prevention (CDC) estimates that 27 million surgical procedures are performed in the United States each year. The CDC's National Nosocomial Infections Surveillance system reports that surgical site infections are the third most frequently reported nosocomial infection, accounting for 14% to 16% of all such infections.
Preventing infection by properly preparing the skin before incision is thus a vital part of the overall care given to women during caesarean birth. The incidence of abdominal incisional infections following caesarean section ranges from 3% to 15%.A post-caesarean surgical site infection is a bacterial infection in the surgical incision following an abdominal birth. Women who develop a post-caesarean surgical site infection typically experience a temperature of 38.0°C (100.4°F) or higher and lower abdominal pain. Abdominal incisional abscesses that develop following caesarean birth usually cause fever on about the fourth postoperative day.
In many cases, these are preceded by uterine infection, and fever persists from the first or second postoperative day. Wound redness (erythema) and drainage may also be present. Organisms causing these infections are usually the same as those isolated from amniotic fluid at caesarean birth, but hospital-acquired pathogens may also be the cause. Some women are more likely than others to develop a post-caesarean surgical site infection.Women at increased risk include those who are obese; have diabetes or an immunosuppressive disorder (HIV infection); have chorioamnionitis (infection of the amniotic fluid and fetal membrane) during labor; anemia; or are taking corticosteroids.
Proper preparation of an incision site involves removing surface dirt and oil with a soap or detergent scrub plus applying a topical antimicrobial agent that will reduce the bacterial population to a minimal level.If prophylactic antimicrobials are given, the incidence of abdominal wound infection following cesarean delivery ranges from 2 to 10 percent depending on risk factors. Numerous good quality trials have proved that a single dose of an antimicrobial agent given at the time of cesarean delivery significantly decreases infection morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Povidone-Iodine10%) | Active comparator | Drug: BetadineAbout 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 10% solution. |
| Group B (Saline0.9%) | Active comparator | Drug: BetadineAbout 100 patients women who underwent elective caesarian section with subcutaneous tissue irrigation with normal saline0.9% |
| Group C (the control group) | Placebo comparator | Drug: BetadineAbout 100 patients women who underwent elective caesarian section without irrigation of the subcutaneous tissue with betadine or saline. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary Elective Cs .
- Age: 20 - 35 years old,
- elective caesarean section time from skin incision to skin closure less than 60 minute,
- Body Mass Index: 20- 30 Kg/m2.
Key exclusion criteria (7 listed)
- Diabetes mellitus,
- feverish patient,
- patient using steroids for chronic illness,
- prelabour rupture of membrane,
- difference in pre and postoperative hemoglobin more than 10%,
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 |
|---|---|---|
| BetadineAlso: SalineTo compare between Betadine (10%) and saline (0.9%) in swapping of subcutaneous tissue for prevention of surgical site infection after primary elective caesarian section. | Drug | Group A (Povidone-Iodine10%), Group B (Saline0.9%), Group C (the control group) |
Primary outcome
Treatment of surgical site infections
Time frame: 6 weeks after cesarean section
Assessment of Number of Participants With Treatment of surgical site infections using Povidine Iodine or by using saline and which one is effective in Treatment
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 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Ahmed Abd El Hameed Ahmed, Professor study chair
Obstetrics and Gynecology Department, Faculty of medicine, Al-Azhar University, Assuit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betadine in people with Surgical Site Infection, run by Egymedicalpedia 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 4 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: finished, as of the sponsor's last update on 23 Sep 2024. 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.
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?
Treatment of surgical site infections (time frame: 6 weeks after cesarean section). 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 23 Sep 2024.