Comparison of the efficacy of Cefazolin and Naproxen with Cefazolin only in the treatment of cellulitis
Design
A double-blind randomized Clinical trial with a control group, with parallel groups, on 60 patients.
Settings and conduct
This study was performed on patients with cellulitis admitted to Labbafinejad hospital, Tehran, Iran in 2020. After obtaining informed consent, eligible patients were randomly divided into two groups A and B. Intervention group (B) received Cefazolin (1-1.5 g intravenously every 8 hours) and Naproxen (500 mg orally every 12 hours). And control group (A) received Cefazolin only (1-1.5 g intravenously every 8 hours). Then, an assessor evaluated the response of patients in each group to the medications prescribed. In this study, patients and the assessor of response to therapy did not know the names of patients in the control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients with a diagnosis of cellulitis; Age over 18 years; Willingness to participate in this clinical trial.
Exclusion criteria: Allergy to Penicillin, Cefazolin or Naproxen; Pregnant women; Immunodeficiency; Patients with mucocutaneous diseases; Patients with kidney diseases; Patients with vascular catheters; Patients suspected of having septic arthritis or osteomyelitis; Patients with infected diabetic foot ulcers; Bite or the presence of a foreign body in the wound; Perianal cellulitis; Injecting substance abuse; Hospitalization during the last three months; Chronic hemodialysis patients.
Intervention groups
Group A was treated with Cefazolin alone.
Group B was treated with Cefazolin in combination with Naproxen.
Main outcome variables
Body temperature; Improvement of clinical symptoms; Hospitalization time average; Epigastric pain; Itching; Diarrhea; skin rash.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201204049598N1
Registration date:2021-09-08, 1400/06/17
Registration timing:retrospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Sadaf Saket
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2231 3681
Email address
dasdd272@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Cefazolin and Naproxen with Cefazolin only in the treatment of cellulitis
Public title
Effect of Naproxen in the treatment of cellulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with a diagnosis of cellulitis
Age over 18 years
Willingness to participate in this clinical trial
Exclusion criteria:
Allergy to Penicillin, Cefazolin or Naproxen
Pregnant women
Immunodeficiency
Patients with mucocutaneous diseases
Patients with kidney diseases
Patients with vascular catheters
Patients suspected of having septic arthritis or osteomyelitis
Patients with infected diabetic foot ulcers
Bite or the presence of a foreign body in the wound
Perianal cellulitis
Injecting substance abuse
Hospitalization during the last three months
Chronic hemodialysis patients
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers, patients are randomly divided into two groups of intervention and control, and receive the medication of the same group.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, written informed consent is obtained from patients. Based on the list prepared by the researcher, the clinician prescribes two types of medication regimens for patients: the intervention group receives Cefazolin (1-1.5 gram intravenously every 8 hours) and Naproxen (500 milligram orally every 12 hours), and the control group receives Cefazolin only (1-1.5 gram intravenously every 8 hours). An individual, then evaluates the clinical outcome. In this study, patients and clinical outcome assessors are not aware of the names of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of school of medicine; Shahid Beheshti university of medical sciences
Street address
School of medicine of Shahid Beheshti university of medical sciences, Koudakyar Ave., Daneshjoo Blvd., Velenjak.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.86
Health conditions studied
1
Description of health condition studied
Cellulitis
ICD-10 code
L03
ICD-10 code description
Cellulitis and acute lymphangitis
Primary outcomes
1
Description
Erythema
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
2
Description
Warmth
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
3
Description
Tenderness
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
4
Description
Body temperature
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Using a mercury thermometer
5
Description
Reduce exudate secretion from the wound
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
6
Description
Hospitalization duration
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Medical record
Secondary outcomes
1
Description
Epigastric pain
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
2
Description
Diarreha
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
3
Description
Itching
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
4
Description
Skin rash
Timepoint
Before the intervention, 2, 3, and 5 to 7 days after the start of the intervention
Method of measurement
Trained doctor report
Intervention groups
1
Description
Intervention group: The intervention group received Cefazolin (1.5-1 g intravenously every 8 hours) and Naproxen (500 mg orally every 12 hours) until the end of hospitalization. The drugs used are the product of Dr. Abidi.
Category
Treatment - Drugs
2
Description
Control group: The control group received Cefazolin only (1.5-1 g intravenously every 8 hours) until the end of hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Sadaf Saket
Street address
Labbafinejad hospital, 9th Boostan St., Pasdaran St., Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2254 6026
Email
dasdd272@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Infectious diseases and tropical medicine research center
Street address
School of medicine of Shahid Beheshti university of medical sciences, Koudakyar Ave., Daneshjoo Blvd., Velenjak.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
idtmrc@sbmu.ac.ir
Web page address
http://idtmrc.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadaf Saket
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 24, Gol Ave., Shahid Araghi St., Tehran
City
Tehran
Province
Tehran
Postal code
1664943813
Phone
+98 21 2231 3681
Email
dasdd272@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadaf Saket
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 24, Gol Ave., Shahid Araghi St., Tehran
City
Tehran
Province
Tehran
Postal code
1664943813
Phone
+98 21 2231 3681
Email
dasdd272@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadaf Saket
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 24, Gol Ave., Shahid Araghi St., Tehran
City
Tehran
Province
Tehran
Postal code
1664943813
Phone
+98 21 2231 3681
Email
dasdd272@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only the outcome data can be published.
When the data will become available and for how long
Access starts 6 months after the article is published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
After the article is published, the data is available
From where data/document is obtainable
The first author of the article
What processes are involved for a request to access data/document
After sending an email to the first author of the article, the data will be available within four weeks.