Investigating the effect of antibiotic prophylaxis on postoperative infection in patients who are candidates for rhinoplasty: a randomized controlled trial.
To determine the effect of antibiotic prophylaxis on postoperative infection in patients who are candidates for rhinoplasty
Design
A clinical trial with a control group, parallel, randomized, phase 3 on 168 patients. The website https://www.sealedenvelope.com was used for randomization.
Settings and conduct
The study will be conducted as a clinical trial in four groups at the Amir al-Mominin hospital in Rasht city.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patientsbetween 20 to 70 years, candidates for rhinoplasty , not receiving antibiotic before study
Exclusion Criteria: Patients with comorbidities like diabetes, thyroid, cardiovascular complications(ischemic heart disease, active hepatitis)
Non-adherence to the treatment protocol or leaving it before complete recovery, patient withdrawal from participating in the study
Patients with septal perforation American society of aesthediology score > 3 (patients with diabetes with poor blood sugar control, high blood pressure, COPD, body mass index above 40)
Alcohol dependence
More than 3 hours of surgery
Intervention groups
The first group was administered a single intravenous dose of 2 grams of Cefazolin (3 grams in individuals weighing over 120 kg) and 900 milligrams of Clindamycin by injection in case of beta-lactam allergy before surgery (during induction of anesthesia). The second group received two intravenous doses of Cefazolin (2 grams for individuals under 120 kg and 3 grams for individuals over 120 kg) and 900 mg of Clindamycin in case of beta-lactam allergy before surgery (at the time of induction of anesthesia) and 4 hours later. The third group was prescribed oral antibiotics, Cephalexin 500 mg four times a day for up to 5 days following surgery. The control group did not receive any antibiotic prophylaxis.
Main outcome variables
Inflammation and infection at the site of surgery, cellulitis, and swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240721062498N1
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Vahid Aghsaghloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 8306
Email address
dr.vahiiiiid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-27, 1403/07/06
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of antibiotic prophylaxis on postoperative infection in patients who are candidates for rhinoplasty: a randomized controlled trial.
Public title
Effect of antibiotic prophylaxis on postoperative infection in rhinoplasty candidates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 20 to 70 years old
rhinoplasty candidates
Not receiving antibiotic treatment before study
Exclusion criteria:
Patients who have comorbidities such as diabetes, thyroid disorders, and cardiovascular complications including ischemic heart disease and active hepatitis
Failure to comply with the treatment protocol or prematurely discontinuing treatment before complete recovery
Patient withdrawal from the study participation
Patients who have septal perforation
American society of aesthediology score > 3 (patients with diabetes with poor blood sugar control, high blood pressure, COPD, body mass index above 40)
Individuals with alcohol dependence
Operations that last longer than three hours.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used with the size of 8 equal blocks (ratio 1:1:1:1) using https://www.sealedenvelope.com divided into four groups. "The first group received a single dose of Sefazolin, the second group received two doses of injectable Sefazolin, the third group received oral antibiotics in the form of Cephalexin, and the control group did not receive any antibiotics."
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences' Headquarters - Parastar St. - Rasht
City
Rasht
Province
Guilan
Postal code
41937-1311
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.GUMS.REC.1403.118
Health conditions studied
1
Description of health condition studied
rhinoplasty infection
ICD-10 code
B99.8
ICD-10 code description
Other infectious disease
Primary outcomes
1
Description
Occurrence of cellulitis and abscess
Timepoint
1 day after surgery, 1 week after surgery, 2 weeks after surgery, 1 month after surgery
Method of measurement
Clinical Examination
Secondary outcomes
empty
Intervention groups
1
Description
The first group received a single dose of 2 grams of Cefazolin (3 grams in individuals weighing over 120 kg) prior to operation (at the induction of anesthesia) and 900 milligrams of Clindamycin for individuals allergic to beta-lactams. The second group received two doses of Cefazolin (2 grams for individuals under 120 kg and 3 grams for individuals over 120 kg) at the induction of anesthesia and 4 hours after. The third group received oral antibiotics, 500 milligrams of Cephalexin four times per day for up to 5 days after operation."
Category
Treatment - Drugs
2
Description
The control group does not receive any antibiotic prophylaxis.