Trial no.:	PACTR202403642777387	Date of Approval:	14/03/2024
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

The Impact of the Surgical Site Infection Prevention Bundle Coupled with Adherence to the Surgical Safety Checklist (SSC) on Maternal Sepsis, Readmission, and Index Hospital Stays Among Post-Caesarean Section Women in Central and Northern Zone Tanzania: A Randomized Controlled Trials.

Official scientific title

The Impact of the Surgical Site Infection Prevention Bundle Coupled with Adherence to the Surgical Safety Checklist (SSC) on Maternal Sepsis, Readmission, and Index Hospital Stays Among Post-Caesarean Section Women in Central and Northern Zone Tanzania: A Randomized Controlled Trials.

Brief summary describing the background and objectives of the trial

Background information Standardized maternal health services have been given priority throughout the world, and several interventions have been set and carried out; nevertheless, the risk of getting SSI among post-caesarean women remains a global challenge (Bonet et al., 2018; Brizuela et al., 2020). The current study, which involved more than 2 million people from 58 countries across the world, reported that the worldwide rate of SSI among post-caesarean section delivery women was 5.63% (Manojkumar et al., 2023). Maternal sepsis is a serious adverse effect that contributes to around 11% of world maternal deaths (Ali & Lamont, 2019; Bonet et al., 2018). Routine surveillance has been proved as among SSI prevention strategies that has been recommended by Centre for Disease Control (CDC) as a critical mechanism for providing accurate SSI rates and providing the stimulus for reducing SSI through feedback to relevant healthcare providers (Alfouzan et al., 2019). Research conducted in Tanzania from 2006 to 2015 reported a total of 40,052 deaths of women of childbearing age were reported in Tanzania, and 16.2% of those deaths were directly caused by sepsis, despite the limited data on hospital-based maternal mortality (Bwana et al., 2019). In addition, three months of prospective research at Dodoma Regional Referral Hospital reported that post-caesarean section SSI was 48%, which is regarded as a high rate of SSI (De Nardo et al., 2016). Tanzania has started to implement IPC and AMR stewardship as a collaborative initiative to stop antibiotic resistance and wound sepsis after caesarean section in the country (Gentilotti et al., 2020). Another strategy is the use of postnatal infection surveillance by telephone, such as the one that was conducted in Dar es Salaam, where post-caesarean section SSI was 10.3% (Id et al., 2021). Broad objective To assess the impact of the SSI Prevention Bundle Coupled with Surgical Safety Checklist (SSC) on maternal sepsis, readmission and index hospital stays among post-caesarean section women in central and northern zone Tanzania. Specific objectives 1. To determine the effects of the SSI Prevention Bundle coupled with adherence to the Surgical Safety Checklist (SSC) on maternal sepsis among post-caesarean section women in central and northern Tanzania. 2. To evaluate the effects of the SSI Prevention Bundle coupled with adherence to the Surgical Safety Checklist (SSC) on readmission within 30 days due to surgical wound complications among women who underwent caesarean sections in central and northern Tanzania. 3. To assess the effects of the SSI Prevention Bundle coupled with adherence to the Surgical Safety Checklist (SSC) on index hospital stays among the post-caesarean section women who developed SSI in central and northern Tanzania.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Obstetrics and Gynecology

Sub-Disease(s) or condition(s) being studied

post-caesarean section surgical site infection

Purpose of the trial

Prevention

Anticipated trial start date

04/03/2024

Actual trial start date

20/03/2024

Anticipated date of last follow up

10/05/2024

Actual Last follow-up date

30/05/2024

Anticipated target sample size (number of participants)

374

Actual target sample size (number of participants)

374

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Provision of postcaesarean surgical site infection prevention bundle	Bundle will be provided once	Started a night before operation and finished within one hour before operation	For the intervention group Phase one (pre operative phase) In this phase, baseline data will be obtained from the intervention group; these data will include participants' demographic information, planned date of operation, body weight, and height. Then the standard pre-operative care, in addition to the bundle of care, will be provided. During pre-operative care, either the research assistant or the researcher will perform routine care such as ensuring the completeness of the consent form, administering prophylactic antibiotics, placing the patient’s identification tag, and IV-line insertion. On top of these, the research assistants or researchers will advise and supervise each individual participant on a fully body bath using water and soap a night before the operation, and in the morning of the operation, the participant will be instructed to avoid applying petroleum jelly or body lotion after bathing. Shaving will be strictly prohibited, but if it must be done, then clipping of the hair will be performed by the research assistant or researcher. The participant’s body temperature and blood glucose level will be checked in the morning of the operation before the woman is escorted to the operating theater. The procedure of inserting a urinary catheter and skin preparation will be performed immediately before a participant is escorted to the operating theater. Vaginal cleansing will be performed by using a non-alcoholic antiseptic solution during the insertion of the urinary catheter. Abdominal skin prophylactic antisepsis will be performed by using sterile gauze and an alcoholic antiseptic solution. Immediately after these procedures, the participant will be dressed in a clean operating theater gown and then escorted to the operating theater. 3.7.1.2 Phase two (intra-operative phase) When the individual participant is in the operating room, either the research assistant or the researcher will record the type of surgical procedure, type of lead surgeon, ASA class of the participant, surgical wound class, status of surgical hand preparation, status of surgical skin preparation, start time (cutting time), end time (skin closure time), duration of the surgery, type of surgical prophylaxis given, theatre traffic, prescribed post-operative antibiotics, and their reasons. In addition, the research assistant or researcher will ensure that all IV fluids to be infused in the operating room will be warmed, and the patient will remain covered at all times and allow exposure to the operation site only. Immediately after surgery, wet linens will be removed to ensure that the patient is kept dry at all times to achieve body normothermia. 3.7.1.3 Phase three (post-operative phase) i.e., before discharge and after discharge This will begin as the participant is out of the operating theater, and at this time the research assistant or researcher will check and record participants’ body temperature and continue maintaining normothermia by providing an extra blanket, closing the nearby windows, avoiding unnecessary body exposure, and continuing to administer the warmed post-operative prescribed IV fluids. A random blood glucose level will be controlled within 24 hours after the operation to ensure normoglycemia. In this phase, after day one of the surgery, a research assistant or researcher will have to conduct a first post-operative assessment, which will be concluded within 72 hours. The assessment will focus on checking the participants body temperature, site of incision skin changes such as color change, skin hotness, wound drainage and its characteristics, unexplainable pain, tenderness of the abdomen, or deliberately wound dehiscence in order to ascertain any early signs and symptoms of surgical site infection. These assessments will be conducted daily until the patient is discharged from the hospital. A second follow-up assessment will be performed between the 7th and 10th days for both admitted and those who will be coming for sti	187
Control Group	Will continue with standard care	Once	One hour before operation	Participants in this group will have their baseline data collected by the research assistant or by the researcher, which will include the participant’s demographic information, planned date of operation, body weight, and height. This group will continue with routine peri-operative care, and then follow-up data on the development of SSI will be collected after day one post-operatively and within 72 hours post-operatively. Second data collection will be carried out during their routing post-natal visits, i.e., between days 7 and 10, and end-line data will be collected between days 28 and 30 post-operatively.	187	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
All term pregnant women who will be delivered through planned grade IV caesarean section during the study period Those women who will meet other criteria such as those who will fall under grade III caesarean section because there will be a time to consent them and administer the intervention.	Every term pregnant woman who has known comorbidities, such as chronic illnesses. Pregnant women who match the inclusion criteria but who are under the age of 18 and lack a guardian will be excluded. Additionally, term pregnant women who will be institutionalized, such as convicts, during the data collection period will not be included. However, all term pregnant women who will develop severe intra-operative or post-partum complications such as cardiac arrest or postpartum haemorrhage and receive blood transfusions during the data collection period will be excluded from this study. Not only that, but also all term pregnant women who will present with a fever ≥ 38 °C pre-operatively will be excluded.	Adult: 19 Year-44 Year	18 Year(s)	45 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

19/02/2024

IRREC of The University of Dodoma

Ethics Committee Address
Street address	City	Postal code	Country
Box 259	Dodoma	41107	United Republic of Tanzania

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Post caesarean surgical site infection	It will be measured between day 2 - 3, then repeated between day 7 -10 and between day 28 and 30
Secondary Outcome	Index hospital stays and readmission to the hospital	Within 30 days post operatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Dodoma Regional Referral Hospital in central Zone Tanzania	Box. 904	Dodoma		United Republic of Tanzania
Mt. Meru Regional Referral Hospital in Northern Zone Tanzania	Box. 3092	Arusha		United Republic of Tanzania

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Individual source	Box 748	Dodoma	40478	United Republic of Tanzania

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Permanent Secretary Ministry of Health	Box 743	Dodoma	40478	United Republic of Tanzania	Government

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Wingod Matowo	winchale2007@yahoo.com	+255765590420	Box 743
City	Postal code	Country	Position/Affiliation
Dodoma	40478	United Republic of Tanzania	University of Dodoma
Role	Name	Email	Phone	Street address
Public Enquiries	Walter Millanzi	wcleo87@gmail.com	+255715064060	Box 259
City	Postal code	Country	Position/Affiliation
Dodoma	41107	United Republic of Tanzania	University of Dodoma
Role	Name	Email	Phone	Street address
Scientific Enquiries	Joanes Mboineki	joanesmboineki@gmail.com	+255756310634	Box 259
City	Postal code	Country	Position/Affiliation
Dodoma	41107	United Republic of Tanzania	University of Dodoma

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	IPD will be shared with the study investigator and dissemination will be done through presentation in the seminar within the University of Dodoma and through publication in the journals. Whenever there is information which will lead to identification of the study participant it will be removed.	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	Within 12 months after the completion of the study	Data will be stored in secured cabinet with limited access whereby only study investigator will have an access. In addition, data for this study may be accessed by study investigator and a dedicated statistician.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
None	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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