Surgical Site InfectionsNCT01566734
Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)
A study testing Cefazolin irrigation and Normal Saline Irrigation in people with Surgical Site Infections, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs. Hypothesis: Normal saline or cefazolin irrigation decreases the incidence of SSIs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- Cefazolin irrigation and Normal Saline Irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Dec 2010to Feb 2012
- 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
- pregnant women
- 6 hours passed their rupture of membrane
- needed to undergo cesarean
Who cannot join
- allergy to penicillin
- allergy to cefazolin
- history of immunosuppressive drug use
- gestational diabetes mellitus
- preeclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections
This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.
Hypothesis:
Normal saline or cefazolin irrigation decreases the incidence of SSIs.
Read the detailed description
All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.
- Conditions
- Surgical Site Infections
- Being tested
- Cefazolin irrigation, Normal Saline Irrigation
- Keywords
- Surgical Wound Infection, cefazolin, Cesarean Section
- 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.
Cefazolin irrigationOther
Also called cephazolin, cefazoline, Ancef, Cefacidal
after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients
Normal Saline IrrigationOther
Also called sodium chloride, saline solution
after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients and in the last group
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Experimental | after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients Receives: Other: Cefazolin irrigation |
| Normal Saline | Experimental | after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients Receives: Other: Normal Saline Irrigation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI
Measured: one week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad E Shahrzad, MD, Hormozgan University of Medical Sciences
- Investigators
- Maryam Rahmani, MD, Study director, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566734
- Sponsor's protocol ID
- U1111-1128-4677
- Status last verified
- Oct 2012
- First submitted
- 26 Mar 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections
- ClinicalTrials.gov ID
- NCT01566734
- Acronym / sponsor ID
- U1111-1128-4677
- Conditions
- Surgical Site Infections
- Keywords
- Surgical Wound Infection, cefazolin, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 29 Mar 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.
This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.
Hypothesis:
Normal saline or cefazolin irrigation decreases the incidence of SSIs.
Detailed description
All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Experimental | Other: Cefazolin irrigationafter the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients |
| Normal Saline | Experimental | Other: Normal Saline Irrigationafter the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant women
- 6 hours passed their rupture of membrane
- needed to undergo cesarean
Key exclusion criteria (5 listed)
- allergy to penicillin
- allergy to cefazolin
- history of immunosuppressive drug use
- gestational diabetes mellitus
- preeclampsia
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 |
|---|---|---|
| Cefazolin irrigationAlso: cephazolin, cefazoline, Ancef, Cefacidalafter the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients | Other | Cefazolin |
| Normal Saline IrrigationAlso: sodium chloride, saline solutionafter the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients and in the last group | Other | Normal Saline |
Primary outcome
SSI
Time frame: one week after discharge
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 15 Oct 2012.
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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.
Maryam Rahmani, MD study director
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin irrigation and Normal Saline Irrigation in people with Surgical Site Infections, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 3 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 15 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 Iran. 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?
SSI (time frame: one week after discharge). 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 15 Oct 2012.