Surgical Site InfectionNCT03595852
Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection
A study testing Cefazolin in people with Surgical Site Infection, run by University of Rwanda at 1 site in Rwanda.
Trial summary
This is a randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome will be the rate of surgical site infection in 2 groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Mar 2018to 15 Mar 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - All elective non-prosthetic surgical procedures such as hernia, thyroid, hydrocele, undescended testes surgery, removal of orthopedic implants, low risk breast surgical procedures and other all procedures deemed to be clean.
Who cannot join
- - Emergency cases
- Any patient with American Society of Anesthesiologists Score (ASA)>2
- Procedures lasting more than 2 hours
- Patients who were taking antibiotics 2 days prior to operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.
This is a randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome will be the rate of surgical site infection in 2 groups.
Read the detailed description
I will conduct a randomized controlled trial (RCT) of antibiotic prophylaxis versus placebo in clean, non-prosthetic, elective procedures. The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg and 30mg/kg in children) within 30-60 minutes prior to skin incision. The control group will receive a similarly prepared placebo injection (water for injection) 30-60 minutes prior to incision.
I will randomize patients in a 1:1 allocation ratio using a simple randomization. Patients will randomly pick an envelope with a number allocating to antibiotic prophylaxis or placebo. Patients and caretakers will be blinded to the intervention. The surgeon will also be blinded to the intervention. The antibiotic (or placebo) will be pre-mixed by the study investigator and administered by the anesthetist.
Other preventive measures for surgical site infection (SSIs) such as effective surgical hand scrub, proper skin preparation with povidone and sterility of materials and instrument will be applied systematically in all groups. Dressing of the wound will be removed 48 hours after operation and no further dressing will be required. Patients will be followed for development of SSI documented by surgeon at discharge and will be called after 30 days of surgery to address any sign of SSI.
- Conditions
- Surgical Site Infection
- Being tested
- Cefazolin, Placebos
- 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.
CefazolinDrug
Also called ancef
Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
PlacebosDrug
Also called saline
IV normal saline will be given to patients 30-60 minutes prior to incision
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis | Experimental | The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg or 30mg/kg in children given within 30-60 minutes prior to skin incision. Receives: Drug: Cefazolin |
| No prophylaxis | Placebo comparator | The control group will receive a similarly looking prepared placebo injection (normal saline placebos for injection) 30-60 minutes prior to incision. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
surgical wounds will be accessed for signs of surgical site infection at discharge by a treating surgeon and patients will be called 30 days after operation for signs of surgical site infection
Measured: 30 days post operative
Secondary outcomes (2)
mortality
death
Measured: 48 hours post operation
morbidity
morbidity will be defined as any one of the following clinical diagnoses made by a treating surgeon: unplanned reoperation, healthcare associated infection, pneumonia, cardiac arrest, pulmonary embolism
Measured: 48 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion15 Mar 2019
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rwanda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaie Sibomana, University of Rwanda
- Investigators
- FAUSTIN NTIRENGANYA, MMed, FCS, Study director, fostino21@yahoo.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595852
- Sponsor's protocol ID
- 1234
- Status last verified
- Sep 2019
- First submitted
- 3 Aug 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.
- ClinicalTrials.gov ID
- NCT03595852
- Acronym / sponsor ID
- 1234
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of RwandaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 23 Jul 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 randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome will be the rate of surgical site infection in 2 groups.
Detailed description
I will conduct a randomized controlled trial (RCT) of antibiotic prophylaxis versus placebo in clean, non-prosthetic, elective procedures. The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg and 30mg/kg in children) within 30-60 minutes prior to skin incision. The control group will receive a similarly prepared placebo injection (water for injection) 30-60 minutes prior to incision.
I will randomize patients in a 1:1 allocation ratio using a simple randomization. Patients will randomly pick an envelope with a number allocating to antibiotic prophylaxis or placebo. Patients and caretakers will be blinded to the intervention. The surgeon will also be blinded to the intervention. The antibiotic (or placebo) will be pre-mixed by the study investigator and administered by the anesthetist.
Other preventive measures for surgical site infection (SSIs) such as effective surgical hand scrub, proper skin preparation with povidone and sterility of materials and instrument will be applied systematically in all groups. Dressing of the wound will be removed 48 hours after operation and no further dressing will be required. Patients will be followed for development of SSI documented by surgeon at discharge and will be called after 30 days of surgery to address any sign of SSI.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis | Experimental | Drug: CefazolinThe intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing >120Kg or 30mg/kg in children given within 30-60 minutes prior to skin incision. |
| No prophylaxis | Placebo comparator | Drug: PlacebosThe control group will receive a similarly looking prepared placebo injection (normal saline placebos for injection) 30-60 minutes prior to incision. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- - All elective non-prosthetic surgical procedures such as hernia, thyroid, hydrocele, undescended testes surgery, removal of orthopedic implants, low risk breast surgical procedures and other all procedures deemed to be clean.
Key exclusion criteria (4 listed)
- - Emergency cases
- Any patient with American Society of Anesthesiologists Score (ASA)>2
- Procedures lasting more than 2 hours
- Patients who were taking antibiotics 2 days prior to operation
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 |
|---|---|---|
| CefazolinAlso: ancefCefazolin will be given to patients in the experimental arm prophylactically prior to surgery | Drug | Prophylaxis |
| PlacebosAlso: salineIV normal saline will be given to patients 30-60 minutes prior to incision | Drug | No prophylaxis |
Primary outcome
Surgical site infection
Time frame: 30 days post operative
surgical wounds will be accessed for signs of surgical site infection at discharge by a treating surgeon and patients will be called 30 days after operation for signs of surgical site infection
2 secondary outcomes
mortality
Time frame: 48 hours post operation
morbidity
Time frame: 48 hours post operation
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 Sep 2019.
- Individual participant dataSharing planned: No. There is no plan to make IPD to other researchers
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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.
FAUSTIN NTIRENGANYA, MMed, FCS study director
fostino21@yahoo.fr
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 in people with Surgical Site Infection, run by University of Rwanda at 1 site in Rwanda.
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 4 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 Sep 2019. 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 Rwanda. 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?
Surgical site infection (time frame: 30 days post operative). 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 Sep 2019.