The aim of this study was evaluation of dressing effect on infection rate after facial melanocytic nevus excision. 468 nevi from individuals, who are candidates for facial melanocytic nevus excision, were selected. Surgery was performed by a dermatologist based on punch or ellipse techniques in the operating room of Razi hospital. After excision wound site was covered by a vaselinated gauze without using an antibiotic ointment. Patients were devided to 2 groups. For patients of first group undressing the wound and washing were not performed within the first 48 hours but after this duration wound washing with water will be done. Patients of the other group uncover their wound after24 hours and wash it. Patients did not use systemic or topical antibiotics, anti septic, supplements, vitamins, repair creams during the study after dressing removal. Patients came back 4-6 days later for suture removal or sooner when infection symptoms occurred. The infection rate of two groups was compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101125601N1
Registration date:2011-04-12, 1390/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-12, 1390/01/23
Registrant information
Name
Pardis Kiani
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 9952
Email address
kiani_p@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of infection rate after facial melanocytic nevi excision in two wet and dry groups (with and without exposure to water after first 48hours)
Public title
The effect of dressing after facial melanocytic nevi excision on infection rate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:1- patients with facial melanocytic nevi; 2-candidate or volunteer for nevus excision; 3- consent for participation in the study and 4- possibility of following up after surgery for evaluating wound infection. Exclusion criteria:1- patients with recent burn in the lesion sites; 2-very obese patients (BMI more than 35); 3- patients who were receiving antibiotics for any reason; 4- patients who were under treatment of systemic antibiotics after surgery; 5-patients with history of Diabetes or COPD; 6-patients who had taken immunosuppressive drugs within recent 3 months; 7-patients who were under phototherapy in the recent three months; 8- patients who need flap for lesion reconstruction and finally patients who need suturing subcutaneous tissue at the time of nevi excision.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
468
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran university of medical sciences, Razi hospital
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Postal code
Approval date
2009-09-27, 1388/07/05
Ethics committee reference number
344
Health conditions studied
1
Description of health condition studied
Infection rate after facial melanocytic nevus excision based on dressing duration
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified
Primary outcomes
1
Description
infection after facial melanocytic excision
Timepoint
4-6 days after nevus excision (suture removal time)
Method of measurement
clinical inspection of infection signs by dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
control group patients should keep their wound dressed for 48hours.
Category
Prevention
2
Description
patients in intervention group should remove the dressing 24 hours after surgery and wash the wound normally.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Pardis Kiani
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences, Razi hospital
Full name of responsible person
Dr Narges Ghandi
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sciences, Razi hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Narges Ghandi
Position
dermatology assisstant professor
Other areas of specialty/work
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
nghandi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Narges Ghandi
Position
assisstant professor
Other areas of specialty/work
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
nghandi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Pardis Kiani
Position
dermatology resident
Other areas of specialty/work
Street address
Razi hospital, Vahdat Eslami square
City
Tehran
Postal code
Phone
+98 21 5560 9952
Fax
Email
kiani_p@razi.tums.ac.ir, pardis_kiani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)