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Trial registered on ANZCTR


Registration number
ACTRN12618000483257
Ethics application status
Approved
Date submitted
19/12/2017
Date registered
3/04/2018
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The outcome of the hospital protocol for prevention of surgical site infection during cesarean deliveries
Scientific title
The outcome of the hospital protocol for prevention of surgical site infection during cesarean deliveries
Secondary ID [1] 293639 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection during cesarean deliveries 305915 0
Condition category
Condition code
Infection 305637 305637 0 0
Other infectious diseases
Reproductive Health and Childbirth 305638 305638 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The hospital protocol for prevention of surgical site infection includes;
1) Strict glycemic control in diabetic women before the cesarean delivery.
2) Preoperative antiseptic showering with 4% chlorhexidine gluconate the night before surgery.
3) Administration of prophylactic intravenous antibiotics within 60 minutes before the skin incision.
4) Higher dose of preoperative antibiotics in obese women.
5) Use of clippers for hair removal pre-operatively.
6) Use of chlorhexidine-alcohol for skin preparation immediately before surgery.
7) Use of an alcohol-based hand rub for preoperative antisepsis.
8) Closure of the skin using sub-cuticular sutures.
9) Closure of the subcutaneous tissue if the subcutaneous tissue thickness is more than or equal 2 cm .
10) Avoid unproven techniques.
Follow–up of the studied women for one month after the cesarean delivery to check the primary outcome. The primary outcome measures; the incidence of surgical site infection after application of the hospital protocol for prevention of the surgical site infection, compared by incidence of the surgical site infection for one year before application of the hospital protocol.
Surgical site infection defined as infection, and invasion of the incision made by the surgeon during the delivery by the micro-organisms.
Intervention code [1] 300400 0
Diagnosis / Prognosis
Comparator / control treatment
Simply we will evaluate the incidence of the surgical site infection during cesarean deliveries after implementation of this protocol (study group), during the year 2018. Compared by the incidence of surgical site infection during cesarean deliveries one year before implementation of this protocol (controls), during the year 2017.
Follow up of women in the exposure group for one month after the cesarean deliveries, while post-operative follow up of the control group one month after cesarean deliveries will be collected from their registered data [follow up of the historical control one month after cesarean deliveries]. Where there was no definite protocol for prevention of surgical site infection after cesarean deliveries [each surgeon doing his own believes]
surgical site infection defined as infection, and invasion of the incision made by the surgeon during the delivery by the micro-organisms.
Control group
Historical

Outcomes
Primary outcome [1] 304275 0
The outcome measures; the incidence of surgical site infection during cesarean deliveries after application of the hospital protocol [during 2018] compared with the incidence of surgical site infection during cesarean deliveries before application of the hospital protocol [during 2017].
Surgical site infection defined as infection, and invasion of the incision made by the surgeon during the delivery by the micro-organisms.
Time point for assessment of outcome in each woman 4 weeks after the delivery by CS [one month]
Timepoint [1] 304275 0
Primary outcome assessed in each woman within 4 weeks [one month] after the CS.
Secondary outcome [1] 341461 0
Possible risks for increase the surgical site infection during cesarean deliveries as obesity using the body mass index [weight in kilograms/height in meters].
Weight and height will be measured to determine the body mass index based on self-report of weight and height, then will be determined using weighted scales and the height measured using a tape measure immediately preoperative on admission before the cesarean delivery.
Timepoint [1] 341461 0
Possible risks for increase the surgical site infection during cesarean deliveries as obesity using the body mass index [weight in kilograms/height in meters].
Weight and height will be measured to determine the body mass index based on self-report of weight and height, then will be determined using weighted scales and the height measured using a tape measure immediately preoperative on admission before the cesarean delivery.
Secondary outcome [2] 343459 0
Possible risks for increase the surgical site infection during cesarean deliveries as diabetes during pregnancy using the data of the oral glucose tolerance test.
Timepoint [2] 343459 0
Oral glucose tolerance test will revised from the patients data registered on admission before the cesarean deliveries.
Secondary outcome [3] 343460 0
Possible risks for increase the surgical site infection during cesarean deliveries as anemia using the complete blood picture before the cesarean deliveries to detect the preoperative and postoperative hemoglobin.
Timepoint [3] 343460 0
The pre-operative hemoglobin will checked on admission and the postoperative hemoglobin usually checked on postoperative day 2.

Eligibility
Key inclusion criteria
Women between 20-40 years old, attending the Obstetrics, and Gynecology department of Ahmadi, Kuwait Oil Company (KOC) hospital for elective cesarean delivery during the period from January 2018 till December 2018 after informed consent (study group), and approval of the department.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes; emergency cesarean sections, and/or women refused to participate or to give consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The required sample size was calculated using G Power software version 3.17 for sample size calculation (Heinrich Heine Universität; Düsseldorf; Germany), setting a -error probability at 0.05, power (1- ß error probability) at 0.95%, and effective sample size (w) at 0.3.
Collected data will statistically analysed using Statistical Package for Social Sciences (SPSS); computer software version 20 (Chicago, IL, USA). Chi-square test (x2) for qualitative variables, and student (t) test for comparison numerical variables. The Odds ratio, and the relative risk analysis for detection of the possible risks for surgical site infection during cesarean deliveries.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9452 0
Kuwait
State/province [1] 9452 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 298258 0
Hospital
Name [1] 298258 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 298258 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 298258 0
Kuwait
Primary sponsor type
Hospital
Name
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 297370 0
Individual
Name [1] 297370 0
Ibrahim A. Abdelazim
Address [1] 297370 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 297370 0
Kuwait
Secondary sponsor category [2] 297371 0
Individual
Name [2] 297371 0
Mohannad AbuFaza
Address [2] 297371 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [2] 297371 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299261 0
Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 299261 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 299261 0
Kuwait
Date submitted for ethics approval [1] 299261 0
25/12/2017
Approval date [1] 299261 0
04/01/2018
Ethics approval number [1] 299261 0

Summary
Brief summary
Background: The cesarean deliveries represent 32.7% of all births in the United States. In addition, more than half of all pregnancies are complicated by maternal obesity, which associated with an increased risk of cesarean delivery as well as subsequent wound complications.
Objectives: This study designed to evaluate the outcome after the implemented hospital protocol for prevention of surgical site infection (SSI) during cesarean deliveries in Ahmadi, hospital, Kuwait.
Trial website
Trial related presentations / publications
Public notes
The protocol for the prevention of SSI during cesarean section already approved by the hospital management and will start in January 2018 for the whole hospital. The study will compare the rate and incidence of surgical site infection during cesarean deliveries during the year 2018 compared by the rate of surgical site infection during cesarean deliveries before implantation of the protocol during the year 2017.
Attachments [2] 2425 2425 0 0

Contacts
Principal investigator
Name 79826 0
Prof Ibrahim A. Abdelazim
Address 79826 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79826 0
Kuwait
Phone 79826 0
+965-66551300
Fax 79826 0
Email 79826 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 79827 0
Prof Ibrahim A. Abdelazim
Address 79827 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79827 0
Kuwait
Phone 79827 0
+965-66551300
Fax 79827 0
Email 79827 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 79828 0
Prof Ibrahim A. Abdelazim
Address 79828 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79828 0
Kuwait
Phone 79828 0
+965-66551300
Fax 79828 0
Email 79828 0
dr.ibrahimanwar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Line-by-line data collected from each participant.
When will data be available (start and end dates)?
Start date 15/5/2018
End date 1/4/2019
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
By what mechanism will data be made available?
Access subject to approvals by principal investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
Summary results
Not applicable