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Comparing the effects of conventional surgery with resection of a layer of dermis and epidermis on decreasing the rate of surgical wound infection and dehiscence in high risk patients operated for obstetric or gynecologic conditions

Protocol summary

Summary
The main goal of this study is to determine the effects of resection of a layer of derm and epiderm on reducing surgical wound infection and dehiscence in high risk patients for these complications. A randomized single blind clinical trial will be enrolled in Talegani and Alzahra hospital of Tabriz-Iran. The researcher or the surgeon, in contrast of the patient, will be aware of the technique of the operation for each patient. In this study we will compare the excision of a thickness of 0.5-1 cm of cutaneous and subcutaneous tissue from each side of the surgical wound with the traditional closing of the subcutaneous and cutaneous tissue. Seven hundred and forty women candidate of cesarean or other gynecologic operations with these inclusion criteria: moderate to severe obesity, diabetes, suppressed immunity, systemic and chronic illnesses, cesarean section for meconium defecation, ruptured membrane, prolonged labor and dystocia, prolonged operation and exclusion criteria: bleeding illnesses, cardiovascular diseases or critical conditions requiring to urgently terminate the surgery, active infection like bacteremia, septicemia, pelvic or abdominal abscess, gynecologic cancers will be studied. They will be divided randomly into two groups of 370 by Rand List software. The two groups will be followed for ten days after the surgery by physical examination for signs of infection like erythema, tenderness, discharge and dehiscence. The data will be analyzed with SPSS 15 to demonstrate the rule of this technique in reducing wound infection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206165485N3
Registration date: 2013-02-03, 1391/11/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-03, 1391/11/15
Registrant information
Name
Nazli Navali
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medecine
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 2879
Email address
navalin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences, Research Deputy, Women Health Research Center
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2012-12-06, 1391/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of conventional surgery with resection of a layer of dermis and epidermis on decreasing the rate of surgical wound infection and dehiscence in high risk patients operated for obstetric or gynecologic conditions
Public title
resection of a layer of skin and decreasing surgical wound infection and dehiscence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patient with moderate to severe obesity (BMI=30-40) , subcutaneous fat thickness over 5 cm, diabetes, suppressed immunity, systemic and chronic illnesses, cesarean section for meconium defecation, ruptured membrane, prolonged labor and dystocia, cesarean lasting more than 2 hours, gynecologic operations lasting more than 3 hours, presence of scars in the operative field Exclusion criteria: patient with bleeding illnesses, cardiovascular diseases or critical conditions requiring to urgently terminate the operation, active infection like bacteremia, septicemia, pelvic or abdominal abscess, chorioamnionitis, acute PID, severe bleeding, cancer
Age
From 15 years old to 75 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 740
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street
City
Tabriz
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
5/4/2828

Health conditions studied

1

Description of health condition studied
wound infection
ICD-10 code
O86.0, T8
ICD-10 code description
Disruption of operation wound, Infection of obstetric surgical wound

Primary outcomes

1

Description
wound infection
Timepoint
third and tenth of the operation
Method of measurement
physical examination

Secondary outcomes

1

Description
wound dehiscence
Timepoint
third and tenth day of the operation
Method of measurement
physical examination

Intervention groups

1

Description
In the study group, at the end of the operation, that is done by an obstetrics and gynecology resident, after closing the fascia, a layer of 0,5-1 cm of the skin and subcutaneous tissue is excised with a scalpell all the length of the wound and then the subcutaneous tissue and the skin is closed.
Category
Treatment - Surgery

2

Description
In the control group the skin and subcutaneous tissue is closed routinely without excising them.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Nazli Navali
Street address
South Artesh Street
City
Tabriz

2

Recruitment center
Name of recruitment center
Talegani Hospital
Full name of responsible person
Dr.Nazli Navali
Street address
Rahahan Square
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Women's Reproductive Health Research Center
Full name of responsible person
Dr.Elahe Saheb Olad Madarec
Street address
South Artesh Street
City
Tabriz
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, Women's Reproductive Health Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Navali
Position
assistant professor/ board certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
No. 59, Sahand Street, Emam Khomeyni Avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1334 5416
Fax
Email
navalin@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.Nazli Navali
Position
assistant professor/ board certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
No. 59, Sahand Street, Emam Khomeyni Avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1334 5416
Fax
Email
navalin@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.Nazli Navali
Position
assistant professor/ board certificate of obstetrics and gynecology
Other areas of specialty/work
Street address
No. 59, Sahand Street, Emam khomeyni Avenue
City
Tabriz
Postal code
5138665793
Phone
+98 41 1334 5416
Fax
Email
navalin@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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