Research Proposal

This research proposal focuses on the impact of using single antiseptic agent versus double antiseptic agent on the infection outcome of C-section patients. The literature review highlights the importance of infection control measures in preventing surgical site infections. The conceptual framework and methodology outline the research design and data collection procedures. The analysis will compare the infection outcomes between the two groups. The study aims to provide evidence for improving patient safety.

Running head: RESEARCH PROPOSAL
RESEARCH PROPOSAL
Name of the Student:
Name of the University:
Author Note:

1RESEARCH PROPOSAL
Literature Review:
Previous Studies:
A number of research studies have been conducted in the field of preoperative skin
preparation using both single agent antiseptic versus combination of antiseptics and the
cumulative outcome in reduction of infection has also been assessed among patients
undergoing C-section delivery (Dumville et al. 2016). In this regard, it should be mentioned
that the Standards of practice developed by the AST states that proper fostering patient skin
preparation using antiseptic technique can help to prevent infection outcome (Ast.org 2019).
The standards of practice developed by the AST comprise of 10 standards of practice which
are expected to be followed by the care professionals in order to procure positive patient
outcome (Ast.org 2019). It should further be noted in this regard that the anti-infection skin
preparation is expected to be carried out by the professionals in accordance to the orders of
the Surgeon. A research study conducted by Allegranzi et al. (2011), mentioned that the
surgical infections post C-section delivery in patients could be avoided with the maintenance
of effective perioperative infection prevention measures. Research studies further mention
that the application of a set of simple interventions can help to acquire positive health
outcome (Allengranzi et al. 2016). The set of interventions, broadly comprise of substantial
skin preparation, appropriate selection and use of antibiotics and their dosage, adapting
measures to control the crowd within the clinical setting can help to drastically reduce
infection rates (Berrios-Torres et al. 2017). Research studies further mention that the use of
sterile techniques in association with appropriate maintenance of normothermia as well as
using routine swab counting can help to ensure patient safety and prevent the prevalence of
infections (Berros-Torres et al. 2017). In addition to this, commencement of supplemental
oxygen and the use of the WHO surgical safety checklist can help to procure a safe surgical
environment (Dumville et al. 2016). The evidence base in this regard suggests that factors

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such as interruption of the flow of the process, poor communication between
multidisciplinary care professionals engaged in the care process as well as poor quality of the
operation theatre resources alleviated the risk of acquiring patient infection (Allegranzi et al.
2016). In addition to this, interrupted power supply, poor quality of water, poor autoclave
functioning and lack of knowledge among care professionals about infectious
microorganisms and their susceptibility to broad spectrum antibiotics escalates patient safety
issues (Berrios-Torres et al. 2017). According to a report published by the World Health
Organization (2019), it has been mentioned that the prevalence of surgical site infection is
increasing at an alarming rate which requires immediate intervention to improve patient
safety outcome. In this context, it should be mentioned that the Global Surg Collaborative
reported conducted an epidemiological study to investigate the patient outcome in patients
who underwent a surgical procedure (Nice.org.uk 2019). The researchers conducted a
prospective cohort study on the global patient population of individuals that were undergoing
gastrointestinal resection within the initial six months of the year 2016 (Davies and Patel
2016). The researchers typically considered the sample size across 343 centres that were
located in 66 countries across the continents of Africa, Asia, Europe, Oceania, South America
and North America (Davies and Patel 2016). The researchers considered the primary outcome
as emergence of surgical site infection within 30 days after the completion of the surgery
(Davies and Patel 2016). The secondary outcomes that were considered included mortality
and patients that required another set of recurrent intervention on account of developing
antibiotic resistance (Davies and Patel 2016). The overall findings of the research study
mentioned that the incidence rate of surgical site infection was equivalent to 12.3% which
ranged in between 9.4% within High Development Index countries to 23.2% within Low
Development Index countries (Davies and Patel 2016). The overall findings of the research
study mentions that there is an extensive need to adapt infection control measures so as to

3RESEARCH PROPOSAL
prevent surgical site infections and enhance the level of patient safety (Davies and Patel
2016).
According to the clinical guidelines published by the National Institute for Health and
Care Excellence, it has been recommended that the use of strong skin antiseptics to cleanse
the skin surface, prior to making the skin incision can help to reduce chances of surgical site
infections (Nice.org.uk 2019). It should further be noted in this regard that the NICE
guidelines recommend the use of aqueous or alcohol based antiseptic preparation at the
surgical site before the incision procedure can help to secure positive patient outcome
(Nice.org.uk 2019). In addition to this, the guidelines also suggest that the antiseptic
preparation with Povidone, Iodine and Chlorhexidine are regarded as the most appropriate for
the prevention of the probability of acquiring a surgical site infection (Nice.org.uk 2019). The
guidelines further suggest that the use of diathermy also helps to prevent surgical site
infection if the antiseptic preparation for the skin surface are efficiently dried by means of
evaporation and the process of pooling of alcohol based preparations is avoided (Nice.org.uk
2019).
Another research study conducted by Guenezan et al. (2019), focused on the infections
caused by the use of short peripheral intravenous catheters within healthcare setting. The
researchers critically mentioned that the PVCs often fail prior to the completion of the
treatment on account of infectious complications (Guenezan et al. 2019). It was stated that the
infectious outcomes result in prolong hospital stay and at the same time increases the
associated healthcare costs and mortality rate. The researchers mention in their paper that the
infectious outcome could be avoided with the use of biocompatible catheters as well as with
the use of 2% chlorhexidine-alcohol in the process of skin preparation (Guenezan et al.
2019). The findings of the researcher mention that 2% chlorhexidine-alcohol is better is an
improved antiseptic agent compared to 5% povidine iodine-alcohol solution (Guenezan et al.

4RESEARCH PROPOSAL
2019). The researchers also mention that the use of improved catheters that are effectively
designed to minimise blood exposure, comprise of needless connectors, equipped with
disinfecting caps and are equipped with the facility of disinfecting caps and flushing PVS
before and after each event of medication administration can help to curtail the patient
infection rates (Guenezan et al. 2019).
Another research study conducted by Tuuli et al. (2016) evaluated the impact of
perioperative skin antisepsis in the prevention of surgical site infection outcome. The
researchers conducted a single-centre, randomized controlled trail in order to investigate that
which method of antisepsis was effective in controlling infection outcome (Tuuli et al. 2016).
The researchers compared and contrasted the use use of chlorhexidine-alcohol versus iodine-
alcohol solution for the prevention of surgical site infection in patients (Tuuli et al. 2016).
The primary outcome that was considered included deep surgical infection within 30 days
post the caesarean delivery (Tuuli et al. 2016). The overall research findings suggested that
the use of chlorhexidine-alcohol for the preparation of perioperative skin reduced the
probability of acquiring a surgical site infection compared to iodine-alcohol solution (Tuuli et
al. 2016).
Another research study conducted by Davies and Patel (2016) also suggested that the
use of a combination of the Chlorhexidine with the Povidone-Iodine solution could help to
effectively reduce infectious outcome. However, the cumulative findings of the researchers
do not offer substantial evidence to support the research hypothesis (Davies and Patel 2016).
A number of research studies have also suggested that the use of Negative Pressure Wound
Therapy can help to effectively manage closed surgical incisions and can prevent associated
infection outcome, however, the evidence regarding the same is limited and requires further
research (Woundsinternational.com 2019; Allegranzi et al. 2016).

5RESEARCH PROPOSAL
Conceptual Framework:
According to Brannen (2017), it has been mentioned that the significance of developing
a conceptual framework while conducting a Randomised Controlled Trail is to understand the
existing association between the applied interventions and the anticipated outcomes. In the
words of Bryman (2017), the conceptual framework helps to understand the effectiveness of
the applied interventions with respect to the induced change within the context and the
expected outcome. In this case, the conceptual framework of parallel group design would be
used where in there would be an experimental group and a comparison group. The
experimental group would be administered a single antiseptic intervention using Povidon and
the comparison group would be administered multiple antiseptic intervention containing
Chlorhexidine plus povidone.
Methodological Issues:
The methodological issues that would be taken note of by the researcher in order to
avoid bias would include the following (Brannen 2017):
 Exhaustive review of the literatures in order to eliminate repetitive research ideas
 Closely evaluate methodological trade-offs that can impact the authenticity and
credibility of the research study
 Specifically take note of the key considerations in order articulate the research
question.
Methodology:
The feasibility of a research design depends on the choice of the research design and
research instrument. In this case, the experimental research design was chosen to address the
articulated research question and objectives. The further section would present an elaborate

6RESEARCH PROPOSAL
description on the overall critical considerations of the methodology in order to conduct an
authentic research.
Research Design:
The research design was chosen as an experimental randomised controlled trial. The
rationale for the same can be explained as nature of the research study which focused on
testing the single antiseptic intervention against the use of multiple antiseptic intervention to
reduce cumulative infection outcome in C-section patients within 30 days post hospital
discharge (McCusker and Gunaydin 2015).
Setting of a study:
The research study would take place within the maternity and child health unit of
ABC hospital. A total of 10 participants would be randomly segregated into the intervention
and the comparison group and the incidence of surgical site infection would be considered
within 30 days post discharge. The intervention group would be administered single
antiseptic techniques and the comparison group would be administered multiple antiseptic
intervention for skin preparation before commencing the incision procedure.
Population:
The population that would be considered for the research study would comprise of ten
patients who would be undergoing C-section delivery within the next one month tenure in the
maternity and child care unit of the XYZ hospital.
Sampling:
The recruited participants would be randomly assigned to the intervention and the
comparison group and accordingly to the single antiseptic agent and the multiple antiseptic

7RESEARCH PROPOSAL
agent would be considered for the skin preparation to evaluate infection outcome within 30
days of hospital discharge.
Sample and its’ size:
The sample that would be considered would comprise of admitted patients expecting
their delivery a week or ten days of the next month. The sample size that would be considered
would comprise of 10 participants who would be assigned to the intervention and comparison
group.
Variables:
According to Patten and Newhart (2017), variables can be defined as parameters that
help to assess the impact of intervention and study their effect on the expected outcome.
Independent:
The independent variables would include the two types of intervention that would be
applied in the intervention group and comparison group that would comprise the use of single
antiseptic agent for skin preparation and multiple antiseptic agent for skin preparation before
commencing the incision procedure.
Dependent:
The dependent variable for the research study would include the incidence of surgical
site infection that would result in recurrent hospitalization within 30 days of hospital
discharge post C-section delivery.
Instrument:
The research instruments that would be used to conduct the research would include,
the use of statistical analysis tool, the use of single and multiple antiseptic agents and the

8RESEARCH PROPOSAL
collected data to measure the rate of recurrent hospitalization pertaining to repetitive surgical
site infection.
Validity and Reliability:
The validity and reliability of the study would be measured on the basis of the Pilot
Test. The statistical test would help to estimate the existing relationship between the
dependent and independent variable and accordingly the analysis would help to evaluate the
credibility of the statistically significant results (Heale and Twycross 2015).
Pilot Study:
The rationale for conducting the pilot study can be explained as the feasibility to
evaluate the parameters of cost, duration, association between the independent and dependent
variables as well as estimation of possible adverse events.
Data Collection Procedure:
The data collection procedure would comprise of considering the recurrent
hospitalization rate of the discharged patients. In addition to this, the patient assessment data
at the time of follow up session would also be considered to estimate the probability of
acquiring surgical site infection (Noble and Smith 2015).
Plan for Data Analysis:
The data analysis would be conducted with the use of the statistical analysis software
such as the SPSS and the relation between the independent and dependent variable would be
measured by means of chi square test.
Ethical Consideration:

9RESEARCH PROPOSAL
Prior to conducting the research, ethical approval would be obtained from the XYZ
hospital where the research would be conducted (McCusker and Gunaydin 2015). Also,
ethical consent would be obtained from the participants who would participate in the research
process.
Data Analysis:
The data analysis would be conducted using the SPSS statistical software and the
obtained results would be analysed and interpreted to estimate implication of the devised
intervention on patient health outcome.
Summary of Analytical Framework:
Objec
tive
Resea
rch
Question
Hypot
hesis (if any)
Sources of
Data
Typ
es of Data
Techni
que of
analysis
To
compare
and contrast
the
infection
outcome
associated
with the use
of single
antiseptic
agent
versus
What
are the
impact of
using single
agent
antiseptic
v/s double
agent
antiseptic
on the
infection
outcome of
Null  Literature
Review
 Recurrent
hospitaliz
ation rate
 Patient
assessme
nt data
during
follow up
session
Prim
ary
Chi-
square test
Anova
Pilot
test

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double
antiseptic
agent
C-section
patients?
Gantt Chart:

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References:
Allegranzi, B., Bischoff, P., de Jonge, S., Kubilay, N.Z., Zayed, B., Gomes, S.M., Abbas, M.,
Atema, J.J., Gans, S., van Rijen, M. and Boermeester, M.A., 2016. New WHO
recommendations on preoperative measures for surgical site infection prevention: an
evidence-based global perspective. The Lancet Infectious Diseases, 16(12), pp.e276-
e287.
Allegranzi, B., Nejad, S.B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L. and
Pittet, D., 2011. Burden of endemic health-care-associated infection in developing
countries: systematic review and meta-analysis. The Lancet, 377(9761), pp.228-241.
Ast.org (2019). [online] Ast.org. Available at:
http://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard_Skin_Prep.
pdf [Accessed 9 Sep. 2019].
Berríos-Torres, S.I., Umscheid, C.A., Bratzler, D.W., Leas, B., Stone, E.C., Kelz, R.R.,
Reinke, C.E., Morgan, S., Solomkin, J.S., Mazuski, J.E. and Dellinger, E.P., 2017.
Centers for Disease Control and Prevention guideline for the prevention of surgical
site infection, 2017. JAMA surgery, 152(8), pp.784-791.
Brannen, J., 2017. Mixing methods: Qualitative and quantitative research. Routledge. P.90
Bryman, A., 2017. Quantitative and qualitative research: further reflections on their
integration. In Mixing methods: Qualitative and quantitative research (pp. 57-78).
Routledge.
Davies, B.M. and Patel, H.C., 2016. Systematic review and meta-analysis of preoperative
antisepsis with combination chlorhexidine and povidone-iodine. The Surgery
Journal, 2(03), pp.e70-e77.

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Dumville, J.C., Gray, T.A., Walter, C.J., Sharp, C.A., Page, T., Macefield, R., Blencowe, N.,
Milne, T.K., Reeves, B.C. and Blazeby, J., 2016. Dressings for the prevention of
surgical site infection. Cochrane Database of Systematic Reviews, (12).
Guenezan, J., Drugeon, B., O’Neill, R., Caillaud, D., Sénamaud, C., Pouzet, C., Seguin, S.,
Frasca, D. and Mimoz, O., 2019. Skin antisepsis with chlorhexidine–alcohol versus
povidone iodine–alcohol, combined or not with use of a bundle of new devices, for
prevention of short-term peripheral venous catheter-related infectious complications
and catheter failure: an open-label, single-centre, randomised, four-parallel group,
two-by-two factorial trial: CLEAN 3 protocol study. BMJ open, 9(4), p.e028549.
Heale, R. and Twycross, A., 2015. Validity and reliability in quantitative studies. Evidence-
based nursing, 18(3), pp.66-67.
McCusker, K. and Gunaydin, S., 2015. Research using qualitative, quantitative or mixed
methods and choice based on the research. Perfusion, 30(7), pp.537-542.
Nice.org.uk (2019). Overview | Surgical site infections: prevention and treatment | Guidance
| NICE. [online] Nice.org.uk. Available at: https://www.nice.org.uk/guidance/ng125
[Accessed 9 Sep. 2019].
Noble, H. and Smith, J., 2015. Issues of validity and reliability in qualitative
research. Evidence-based nursing, 18(2), pp.34-35.
Patten, M.L. and Newhart, M., 2017. Understanding research methods: An overview of the
essentials. Routledge.
Tuuli, M.G., Liu, J., Stout, M.J., Martin, S., Cahill, A.G., Odibo, A.O., Colditz, G.A. and
Macones, G.A., 2016. A randomized trial comparing skin antiseptic agents at cesarean
delivery. New England Journal of Medicine, 374(7), pp.647-55.

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Woundsinternational.com (2019). [online] Woundsinternational.com. Available at:
https://www.woundsinternational.com/resources/details/closed-surgical-incision-
managementunderstanding-the-role-of-npwt [Accessed 9 Sep. 2019].