Surgical Site InfectionNCT03736187
Antibiotics for Prevention of SSI in Obese Women Undergoing CS
A study testing Cephalexin in people with Surgical Site Infection, run by Ain Shams University.
Trial summary
Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cephalexin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Dec 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- obese women under elective CS
Who cannot join
- immunodeficient women
About this study
Official title: Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS
Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS
Read the detailed description
Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection
- Conditions
- Surgical Site Infection
- Being tested
- Cephalexin
- 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.
CephalexinDrug
Also called Metronidazole
Giving cephalexin and metronidazole in one group \&cephalexin alone in another group
| Study group | Role | What they receive |
|---|---|---|
| Cephalexin | Experimental | Group a will receive cephalexin 1gm before skin incision intravenous Receives: Drug: Cephalexin |
| Cephalexin &metronidazole | Experimental | Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision Receives: Drug: Cephalexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection
Fever, redness, ecchymosis and tenderness
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study startApr 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
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.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Groups of obese women under elective cesarean section
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer mohammed abd allah elsayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736187
- Sponsor's protocol ID
- Antibiotics for SSI
- Status last verified
- Nov 2018
- First submitted
- 27 Mar 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Vs Single Antibiotics for Prevention of SSI in Obese Women Undergoing CS
- ClinicalTrials.gov ID
- NCT03736187
- Acronym / sponsor ID
- Antibiotics for SSI
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Nov 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.
Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS
Detailed description
Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 Groups of obese women under elective cesarean section
| Arm | Type | Receives |
|---|---|---|
| Cephalexin | Experimental | Drug: CephalexinGroup a will receive cephalexin 1gm before skin incision intravenous |
| Cephalexin &metronidazole | Experimental | Drug: CephalexinGroup b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- obese women under elective CS
Key exclusion criteria (1 listed)
- immunodeficient women
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 |
|---|---|---|
| CephalexinAlso: MetronidazoleGiving cephalexin and metronidazole in one group \&cephalexin alone in another group | Drug | Cephalexin, Cephalexin &metronidazole |
Primary outcome
Wound infection
Time frame: One week
Fever, redness, ecchymosis and tenderness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalexin in people with Surgical Site Infection, run by Ain Shams University.
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 1 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Wound infection (time frame: One week). 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 2018.