The success rate of the combination of healing with secondary intention and flap compared to healing with secondary intention in patients with basal cell carcinoma surgery
Success rate of combined secondary repair with flap compared to secondary repair alone in skin surgery with skin defects
Design
Phase 3 non-randomized clinical trial on 20 patients, with parallel groups, double-blind
Settings and conduct
This study will be conducted on the results of secondary surgical repair of skin lesions with and without flaps in Sina Hospital, Tabriz. The study is double-blind, and the doctor evaluating the outcome of the study and the person analyzing the data are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Patients with skin lesions requiring surgical repair will be included in the study. Pregnant patients, patients with metastases, patients with concomitant cancers, people with coagulation problems, or patients with infection at the site of the lesion, and other uncontrolled systemic diseases will be excluded from the study.
Intervention groups
In intervention group 1, patients will undergo secondary repair surgery with the use of a skin flap. In intervention group 2, patients will undergo secondary skin repair surgery. All patients will be taught to replace the wound dressing with ointment once a day after gentle cleaning with normal saline and apply topical antibiotics and then cover the wound with sterile gauze.
Main outcome variables
Satisfaction of patient and physician with the appearance of the repair site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100314003566N14
Registration date:2024-04-02, 1403/01/14
Registration timing:prospective
Last update:2024-04-02, 1403/01/14
Update count:0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The success rate of the combination of healing with secondary intention and flap compared to healing with secondary intention in patients with basal cell carcinoma surgery
Public title
Investigating the success rate of surgical methods in repairing skin defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for reconstructive skin surgeries
Consent to participate in the study
Exclusion criteria:
Pregnant patients
Patients with metastasis
Patients with cancer
Patients with coagulation disorders
Patients with infection at the site of the lesion surgery
Patients with uncontrolled systemic diseases
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the clinical outcome of the patients at the end of the study and the person analyzing the data will be unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.714
Health conditions studied
1
Description of health condition studied
Skin lesions requiring surgical repair
ICD-10 code
Z48.817
ICD-10 code description
Encounter for surgical aftercare following surgery on the skin and subcutaneous tissue
Primary outcomes
1
Description
Satisfaction with the appearance of the repair site
Timepoint
Three months after surgery
Method of measurement
Observationally and scoring from 0 to 10, where 0 is the lowest score and 10 is the highest satisfaction score
Secondary outcomes
1
Description
Complications
Timepoint
One month, two months and three months after surgery
Method of measurement
Including infection or bleeding at the repair site
Intervention groups
1
Description
Intervention group 1: Patients will undergo secondary repair surgery with the use of a skin flap. Patients will be instructed to replace the wound dressing with ointment once a day after gentle cleaning with normal saline and apply topical antibiotics and then cover the wound with sterile gauze.
Category
Treatment - Surgery
2
Description
Intervention group 2: Patients will undergo secondary skin repair surgery alone. Patients will be instructed to change the wound dressing once a day after gentle cleaning with normal saline and ointment and apply topical antibiotics and then cover the wound with sterile gauze.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Dr. Hamideh Azimi
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2103
Email
azimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Samiee
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 1540 6612
Fax
Email
azimih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 1540 6612
Fax
Email
azimih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 1540 6612
Fax
Email
azimih@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The use request will be emailed to the scientific or public accountability person.