ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000483257

Ethics application status

Approved

Date submitted

19/12/2017

Date registered

3/04/2018

Date last updated

9/02/2022

Date data sharing statement initially provided

16/01/2019

Date results information initially provided

5/02/2021

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]

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

Condition category

Condition code

Infection

Other infectious diseases

Reproductive Health and Childbirth

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]

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]

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]

Primary outcome assessed in each woman within 4 weeks [one month] after the CS.

Secondary outcome [1]

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]

Secondary outcome [2]

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]

Oral glucose tolerance test will revised from the patients data registered on admission before the cesarean deliveries.

Secondary outcome [3]

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]

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

Sex

Females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2018

Actual

15/06/2018

Date of last participant enrolment

Anticipated

2/09/2019

Actual

15/01/2020

Date of last data collection

Anticipated

1/10/2019

Actual

15/04/2020

Sample size

Target

220

Accrual to date

Final

220

Recruitment outside Australia

Country [1]

Kuwait

State/province [1]

Ahmadi hospital, Ahmadi, Kuwait.

Country [2]

Kazakhstan

State/province [2]

Marat Ospanove Medical University, Aktobe, Kazakhastan

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.

Address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

Kuwait

Funding source category [2]

University

Name [2]

West Kazkhastan Marat ospanov Medical University

Address [2]

Maresyev Street, postcode 030012, Aktobe, Kazakhastan.
West Kazkhastan Marat ospanov Medical University, Aktobe, Kazakhstan

Country [2]

Kazakhstan

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]

Individual

Name [1]

Ibrahim A. Abdelazim

Address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1]

Kuwait

Secondary sponsor category [2]

Individual

Name [2]

Mohannad AbuFaza

Address [2]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [2]

Kuwait

Other collaborator category [1]

Individual

Name [1]

Svetlana Shikanova

Address [1]

Maresyev Street, postcode 030012, Aktobe, Kazakhastan.
West Kazkhastan Marat ospanov Medical University, Aktobe, Kazakhstan

Country [1]

Kazakhstan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.

Ethics committee address [1]

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Ethics committee country [1]

Kuwait

Date submitted for ethics approval [1]

25/12/2017

Approval date [1]

04/01/2018

Ethics approval number [1]

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 [1]

/AnzctrAttachments/374192(v19-12-2017-08-12-43)-Prevention of SSI protocol.doc (Protocol)

Attachments [2]

/AnzctrAttachments/374192-Departmental approval SSI.pdf (Ethics approval)

Contacts

Principal investigator

Name

Prof Ibrahim A. Abdelazim

Address

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

[email protected]

Contact person for public queries

Name

Prof Ibrahim A. Abdelazim

Address

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

[email protected]

Contact person for scientific queries

Name

Prof Ibrahim A. Abdelazim

Address

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country

Kuwait

Phone

+965-66551300

Fax

[email protected]

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.

How or where can data be obtained?

Access subject to approvals by principal investigator.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Other Details	Attachment
2067	Ethical approval		Departmental approval of Ahmadi hospital and West ... [More Details]	374192-(Uploaded-10-05-2019-20-01-21)-Study-related document.pdf
10454	Study protocol	Study protocol		374192-(Uploaded-15-05-2020-20-05-41)-Study-related document.doc
10455	Statistical analysis plan			374192-(Uploaded-15-05-2020-20-10-29)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Abdelazim, I.A., Abu-Faza, M., Al-Ajmi, S. et al. ... [More Details]
Plain language summary	No		This study was designed to evaluate the outcome of... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Outcome of the Hospital Protocol for Prevention of Surgical Site Infection After Cesarean Deliveries.	2021	https://dx.doi.org/10.1007/s42399-021-00777-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically