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Comparison of the results of two skin closer methods with subcuticular versus staples methods in obese patients who are candidates for hysterectomy due to benign disease

Protocol summary

Study aim
Comparison of the results of two skin closer methods with subcuticular versus staples methods in obese patients who are candidates for hysterectomy due to benign disease
Design
Clinical trial without control group, with parallel groups, unblinded, randomized, phase 3 on 80 patients. The sealed envelope randomization method will be used for randomization.
Settings and conduct
This study will be conducted in the field of investigating the method of hysterectomy surgical site suture without malignancy in obese patients referred to Al-Zahra Hospital in Tabriz.Patients will be divided into two groups based on the method of skin closure.Demographic information of patients including age, BMI, height, weight, smoking, indication of hysterectomy will be recorded.Surgical time information including the duration of skin closure, the amount of bleeding during surgery, the duration of surgery, the length of incision, the depth of incision, and the need for blood transfusion will be recorded.
Participants/Inclusion and exclusion criteria
In this clinical Trial study, obese women (BMI above 30 kg/m2) candidates for hysterectomy due to benign diseases will be included in the study and patients with a history of previous surgery and diabetes will be prohibited from entering the study.
Intervention groups
Patients will be divided into two groups of 40 people based on the method of skin closure. In group A, skin with subcortical method (intradermal sutures placed under the epidermis and using absorbable or non-absorbable sutures) and in group B, skin with skin stapler method (closing the skin with pieces of It is small metal that is placed by a stapler on both sides of the wound to close the skin) will be closed.
Main outcome variables
The duration of hospitalization and the need for re-suture considered as the main outcome.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120922010901N11
Registration date: 2024-06-22, 1403/04/02
Registration timing: prospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Parvin Mostafa Gharebaghi
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
gharabagh.p@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2025-03-30, 1404/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of two skin closer methods with subcuticular versus staples methods in obese patients who are candidates for hysterectomy due to benign disease
Public title
Comparison of the results of two skin closer methods with subcuticular versus staples methods in obese patients who are candidates for hysterectomy due to benign disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese patients with BMI above or equal to 30 kg/m2 Hysterectomy candidate patients with benign pathology Age between 30 and 59 years
Exclusion criteria:
History of previous surgery Vertical incision Diabetes Anemia
Age
From 30 years old to 59 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided randomly using the randomization method of the sealed envelope into two groups in terms of skin closure, including group A (subcuticular suture) and B (staples).A number of 80 envelopes are prepared and written A is placed in 40 envelopes and B is written in 40 envelopes, and then the envelopes will be sealed. When the patients enter the operating room, the delivery nurse will select the patient from among the sealed envelopes and open it and note the group of patients on the top of the clinical file. Then the surgeon will apply the corresponding suture based on the desired grouping.
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
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Number 2 Central Building, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.TBZMED.REC.1403.104

Health conditions studied

1

Description of health condition studied
آysterectomy
ICD-10 code
O82.2
ICD-10 code description
Delivery by caesarean hysterectomy

Primary outcomes

1

Description
Wound complications (infection, opening, secretions, pain and redness)
Timepoint
2, 4 and 6 weeks after surgery
Method of measurement
Evaluation of surgical wound by clinical examination

2

Description
Duration of hospitalization
Timepoint
Length of hospital stay from surgery to discharge
Method of measurement
Patient file

Secondary outcomes

1

Description
The need for re-suture
Timepoint
At 2, 4 and 6 weeks after surgery
Method of measurement
Evaluation of surgical wound by clinical examination

Intervention groups

1

Description
Intervention group 1: In 40 patients, skin closure will be performed with subcortical method (intradermal sutures placed under the epidermis layer and using absorbable or non-absorbable sutures).
Category
Treatment - Surgery

2

Description
Intervention group 2: In 40 patients, will be closed with the stapler method ( the skin is closed using small metal pieces that are placed on both sides of the wound by a stapler to close the skin).
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
alzahrahosp@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,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. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwife
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
lahroudin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
lahroudin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
lahroudin@gmail.com

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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