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Investigating the effect of local insulin administration on wound healing in diabetic patients who underwent surgery

Protocol summary

Study aim
Determining the effect of local insulin administration on wound healing in diabetic patients who underwent surgery
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 40 patients
Settings and conduct
The current study is a randomized clinical trial that will be conducted on patients referred to Al-Zahra and Shahid Beheshti hospitals to perform laparotomy with Feinstein's standard incision. Controls will be distributed to the patient in sealed envelopes that are coded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. having diabetes, 2. Indication of laparotomy with standard Feinstein incision. 3. Receiving standard prophylactic antibiotics, 4. Declaration of informed consent to participate in the study. Criteria for not entering the study: 1. Have an underlying disease that affects the wound healing process, such as cancer and neoplasm, immunodeficiency, history of chemotherapy and radiotherapy, 2. Re-incision in similar site of previous surgery 3. Visceral injury during surgery 4. Simultaneity of another surgery, 5. The need for blood transfusion during surgery
Intervention groups
Patients in the intervention group underwent subcutaneous wound injection with regular insulin at the rate of 0.2 units per kilogram of body weight diluted with 5 cc of distilled water and then using a 5 cc syringe and insulin needle subcutaneously and uniformly for 10 Feinstein cut centimeter is injected. This injection will be done once a day on the 1st, 2nd, 3rd, 5th and 7th days after the operation.
Main outcome variables
Infection and purulent discharge, pain, necrotizing fasciitis, granulation tissue formation, wound healing time, cellulitis, bleeding, wound surface

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230116057136N1
Registration date: 2023-05-30, 1402/03/09
Registration timing: registered_while_recruiting

Last update: 2023-05-30, 1402/03/09
Update count: 0
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Minoo Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
movahediminoo1345@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of local insulin administration on wound healing in diabetic patients who underwent surgery
Public title
The effect of topical insulin on wound healing in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diabetes Indication of laparotomy with standard Feinstein incision Receive standard prophylactic antibiotics Declaration of informed consent to participate in the study
Exclusion criteria:
having an underlying disease that affects the wound healing process, such as cancer and neoplasm, immunodeficiency, history of chemotherapy and radiotherapy Re-incision in similar site of previous surgery Visceral injury during surgery Simultaneity of another surgery The need for blood transfusion during surgery
Age
From 20 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence is prepared by biostatistics specialist and using excel software, a random table for 40 patients is provided to the researcher. The randomization is based on 4 random blocks because we have two groups of comparisons. Ten blocks of 4 that will be prepared using the sequence table. The allocation of participants is done using concealment with the method of closed envelopes. In this method, the sequence table designed in the previous section is used. Because of the type of intervention (is known), there is no possibility of blindness.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Motahari St., Shahid Dr. Beheshti Hospital
City
Esfahan
Province
Isfehan
Postal code
8184853542
Approval date
2022-11-17, 1401/08/26
Ethics committee reference number
IR.MUI.MED.REC.1401.298

Health conditions studied

1

Description of health condition studied
Laparotomy candidate patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Infection and purulent discharge
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

2

Description
Pain
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

3

Description
Necrotic fascism
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

4

Description
Formation of granulation tissue
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

5

Description
Wound healing time
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

6

Description
Cellulite
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

7

Description
Bleeding
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

8

Description
Wound surface
Timepoint
One week, two weeks, four weeks after cutting
Method of measurement
Physical examination and history

Secondary outcomes

1

Description
Fasting blood sugar test
Timepoint
Before injection and then at an interval of one hour and 4 hours after injection
Method of measurement
Using a glucometer

2

Description
Readmission
Timepoint
Intervals of one week, two weeks, four weeks after cutting
Method of measurement
Patient file

Intervention groups

1

Description
Intervention group: Patients in the intervention group underwent subcutaneous wound injection with regular insulin at the rate of 0.2 units per kilogram of body weight diluted with 5 cc of distilled water and then using a 5 cc syringe and insulin needle subcutaneously and uniformly for 10 Feinstein cut centimeter is injected.
Category
Treatment - Drugs

2

Description
Control group: Patients in the control group will be injected with distilled water (with maximum effort to avoid pain and without any anesthetic)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Mino Movahdi
Street address
Motahari Street, Shahid Beheshti Hospital
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3236 7005
Email
movahedi@med.mui.ac.ir

2

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Mino Movahdi
Street address
Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mino Movahdi
Street address
Isfahan province, Isfahan city, Hazar Jarib St
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
education@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mino Movahdi
Position
Associate professor, specialist doctor of the academic staff
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Medicine
City
Esfahan
Province
Isfehan
Postal code
81746
Phone
+98 31 3620 1274
Email
internal@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mino Movahdi
Position
Associate professor, faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan - Azadi Square - Isfahan University
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
moavenat-amouzeshi@dean.ui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mino Movahdi
Position
Associate professor, medical specialist of the academic staff
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan - Azadi Square - Isfahan University
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2288
Email
movahedi@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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