Assessing the Effect of the Silver Dressing on Surgical Site Infections in Adult Patients Post Cardiac Surgery: a Single Center Randomized Control Trial
Phase: NA
Conditions: Surgical Site Infection After Major Surgery, Surgical Site Infections
Sponsor: King Faisal Specialist Hospital & Research Center

 
 
 
 
 
 
 
Institutional Review Board  
(IRB) 
 
 
 
 
 
 
 
 
 
 
 
 
Application for Approval 
of Research Proposal 
 
 
 
 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
RESEARCH PROPOSAL PACKAGE 
 
 
     
CONTENTS: 
 
 
1. COVER SHEET 
 
2. DEPARTMENTAL APPROVAL FORM 
 
3. ABSTRACT 
 
4. PROPOSAL 
 
5. WORK PLAN & RESPONSIBILITIES 
 
6. REFERENCES 
 
7. BUDGET SHEET 
 
8. PHARMACY INFORMATION SHEET 
 
9. BIOLOGICAL HAZARDS FORM 
 
10. INFORMED CONSENT FORM [KFSH&RC(Gen.Org.)-Jeddah Branch Format]  
 
11. CASE REPORT FORM 
 
 
ANNEX A. CURRICULUM VITAE OF PRINCIPAL INVESTIGATORS 
 
ANNEX B. HUMAN PARTICIPANT PROTECTIONS EDUCATION FOR RESEARCH TEAMS  
               COMPLETION CERTIFICATE  
(FOR RESEARCHERS WHO HAVE NO PUBLISHED RESEARCH PAPERS YET) 
 
 
FOR COLLABORATIVE STUDIES /INDUSTRY STUDIES (COMPANY SPONSORED) 
 
ANNEX C. PROTOCOL / INFORMED CONSENT 
 
ANNEX D. CASE REPORT FORM(S) / QUESTIONNAIRE 
  
ANNEX E. SERIOUS ADVERSE EVENTS (FOR INDUSTRY STUDIES ONLY) 
 
ANNEX F. INVESTIGATOR’S BROCHURE (FOR INDUSTRY STUDIES ONLY) 
   
 
 
 
 
 
Submission Date:  
 
No.  
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
 
1.  IRB RESEARCH PROPOSAL - COVER PAGE 
 
 
3. 
Title of Proposal:  Assessing the effect of the silver dressing on  surgical 
site infections in adult patients post cardiac surgery: a single centre 
randomized control trial. 
 
Duration of Study: 
24 months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BUDGET 
Total 
External Funding 
Requested 
NIL  
NIL  
NIL  
 
 
 
 
 
 
 
 
2.  DEPARTMENTAL APPROVAL 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
Title of Proposal:   Assessing the effect of the silver dressing on surgical site infections in 
adult patients post cardiac surgery: a single center randomized control trial. 
 
 
Approval - Departmental Research Committee: 
The Committee has reviewed this proposal and attests to its scientific validity.  
 
 
 
 
Departmental Research Committee Designee 
 
 
Signature 
 
 
Date 
 
  
 
Approval - Department Head(s): 
I have reviewed this proposal and approve the participation of the concerned personnel of my department in it. 
 
PARTICIPANTS 
 
DEPARTMENTAL CHAIRMAN 
/UNIT HEAD 
SIGNATURE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Declaration of Conflict of Interest: 
 
  All investigators must declare any potential conflict of interest with respect to this research proposal.   
  The presence of such conflict of interest must be explained (see below).  The lack of such declaration by  
  investigators involved with this proposal is taken as evidence of the absence of any conflict of interest. 
 
  
 
 
  Conflict of Interest: 
 
NAME 
SIGNATURE 
EXPLANATION 
 
 
 
 
 
 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
4. ABSTRACT  
   Should not exceed 200 words and should include: 
- The importance of the research topic 
- The research hypothesis, question or statement, specific objectives and the significance of the outcome 
      - OUTLINE the methods that will be used to accomplish the research specific objectives 
 
Background  
Prevalence of surgical site infections in cardiac surgery is about 10%. About 3% of patients who 
develop an SSI will die as a result. Multiple studies confirm that SSIs are a complication with 
significant sequelae, such as longer hospitalisation, increased health costs, increased morbidity 
and mortality. Hence, the prevention and management of wound infections in median sternotomy 
incisions after adult cardiac surgery are crucial for optimizing patient outcomes, 
 
Aim  
To assess the effect of the silver dressing on SSIs rates in adult patients post cardiac surgery. 
 
Methodology  
A single center randomized control trial approach will be employed. Adult patients admitted post 
cardiac surgery with a sternotomy incision will be randomized into the intervention (n=75) or control 
group (n=75). Units will include the cardiac surgical intensive care unit, the coronary care unit and 
the cardiovascular telemetry unit. Intervention will include the use of a silver dressing on the 
sternotomy incisions and the donors sites where applicable. The control group will follow standard 
care processes. Data collection will include a checklist and the modified Parsonnet Score. Data 
analysis will include descriptive and inferential statistics.  
 
Conclusion 
The current rate of surgical site infection amongst cardiac surgical patients is 2.1 below the 
benchmark of 2.9 with an operational goal of 2.1.  
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
5. RESEARCH PROPOSAL: Assessing the  effect of the silver dressing on  
surgical site infections in adult patients post cardiac surgery: a single centre 
randomized control trial. 
 
 
Introduction 
May include background information related to the research topic (Importance of the topic), the purpose in carrying out this 
research, and the importance of potential (expected) findings. 
 
BACKGROUND 
 
Worldwide, cardiovascular diseases are considered the primary contributor to global mortality. 
Annually, around 18 million individuals die from these diseases, with 85% of the fatalities attributed 
to heart attacks (Magnussen et al., 2023). The management of cardiac diseases involves either 
clinical or surgical approaches. Surgical interventions are chosen when they present a greater 
likelihood of cardiac rehabilitation compared to clinical treatments. As a result, surgeries are quite 
common and necessitate meticulous planning for nursing care during the postoperative phase. 
This planning should be based on evidence-based practices to guarantee the delivery of high-
quality care to patients. Furthermore, it aims to proactively prevent complications associated with 
the procedure, including the occurrence of Surgical Site Infections (SSIs)(Pivoto et al., 2010; Vieira, 
Stocco, Ribeiro & Frantz, 2018).  
 
Approximately 0.5% to 3% of patients undergoing surgery will experience infection at or adjacent 
to the surgical incision site. Compared with patients undergoing surgery who do not have a surgical 
site infection, those with a surgical site infection are hospitalized approximately 7 to 11 days longer 
(Seidelman et al, 2023).  
In addition prevalence of SSI in cardiac surgery was 10% (Maleknejad 
2019). About 3% of patients who develop an SSI will die as a result(Awad 2012). Multiple studies 
confirm that SSIs are a complication with significant sequelae, such as longer hospitalisation, 
increased health costs, increased morbidity and mortality(Harder et al, 2013; Predin et al 2021).  
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
Coronary artery bypass graft (CABG) is one of the surgical procedures for coronary artery disease 
(CAD) for exhibiting efficacy in reducing mortality rates and enhancing patients' quality of life 
(Hastalarının, 2019). Moreover, Median sternotomy is a surgical procedure involving a vertical 
incision through the sternum (breastbone) to access the thoracic cavity. This approach is 
commonly employed in various cardiac surgeries, including Coronary Artery Bypass Grafting 
(CABG), valve replacement, and other cardiac procedures. The median sternotomy provides 
direct access to the heart and great vessels, allowing surgeons to perform interventions with a clear 
view of the cardiac structures (King et al., 2022). Nevertheless, certain postoperative complications, 
including delayed healing of chest wounds and persistent incisional pain, adversely impact 
patients' quality of life while also extending hospital stays and elevating treatment costs. 
Wound infections in adult cardiac surgical patients, particularly in the context of median 
sternotomy, can be influenced by various factors. Identifying and understanding these risk factors 
is crucial for implementing effective preventive measures (Biancari et al., 2020). Common risk 
factors include Diabetes Mellitus, obesity, advanced age, immunosuppression, steroid use, 
preoperative antibiotic prophylaxis, chronic respiratory conditions, sterilization and aseptic 
techniques, prolonged surgery duration, and peripheral vascular disease (Vieira, Stocco, Ribeiro & 
Frantz, 2018). 
In fact, the prevention and management of wound infections in median sternotomy incisions after 
adult cardiac surgery are crucial for optimizing patient outcomes, minimizing healthcare costs, and 
preserving the overall quality of life for individuals undergoing this cardiac surgical procedure 
(Phoon & Hwang, 2020). Vigilant postoperative care and evidence-based interventions play a key 
role in achieving these objectives. 
Wound dressings play an important role in preventing infections by creating an optimal 
environment for wound healing and protecting the surgical or injured site from microbial 
contamination (Oliverius et al., 2021). The primary functions of wound dressings in infection 
prevention include barrier Protection, moisture management, absorption of exudate, antimicrobial 
properties, promotion of granulation tissue, reduction of biofilm formation, and promotion of 
oxygenation (Oliverius et al., 2021). 
Effective selection and application of wound dressings depend on various factors, including the 
type of wound, its stage of healing, and the patient's specific needs. Healthcare professionals 
should assess wounds, choose appropriate dressings, and monitoring for signs of infection 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
throughout the healing process (Slamborova et al., 2013). Silver dressing is an example of wound 
dressings that are impregnated or coated with silver or silver-containing compounds. The 
incorporation of silver in wound dressings is based on the antimicrobial properties of silver ions, 
which have been recognized for their ability to inhibit the growth of bacteria, fungi, and some 
viruses.  
Many silver dressings are engineered to provide a controlled and sustained release of silver ions 
over time. This feature ensures a prolonged antimicrobial effect while minimizing the risk of 
cytotoxicity to healthy cells (Slamborova et al., 2013). Furthermore, although silver dressings are 
often utilized in the management of chronic wounds, such as diabetic ulcers, pressure ulcers, and 
venous leg ulcers, however, it can be applied to surgical wounds, including incisions from 
procedures such as cardiac surgery (e.g., median sternotomy), to reduce the risk of Surgical Site 
Infections (SSI) (Abbaszadeganet al., 2017). Their antimicrobial properties aid in controlling 
bacterial load and promoting wound healing. Silver dressings can also help minimize wound-
related odors associated with bacterial colonization. This is particularly relevant in wounds with high 
exudate levels (Woodmansey &Roberts, 2018; Cooper & Kirketerp-Moller, 2018).  
These characteristics make silver dressings a valuable tool in the prevention and management of 
infections in various types of wounds. Silver dressings come in various forms, including gels, foams, 
films, hydrocolloids, and nanocrystalline dressings.  The importance of silver ions in the treatment of 
chronic and especially infected wounds has been demonstrated in many studies (Woodmansey 
&Roberts, 2018; Cooper & Kirketerp-Moller, 2018; Dissemond et al., 2017; Li et al., 2017; Walker & 
Parsons 2014). For example, in 2022, a study was conducted on 218 patients to assess the incidence 
of incisional surgical site infection and primary healing after general surgery procedures (Lawrie et 
al., 2022). The study showed that the surgical site infection (SSI) and primary incision healing were 
reported in 10 (9.2%) versus 21 (19.3%) (p  =  0.037) and in 95 (87.2%) versus 86 (78.9%) (p  =  0.107) 
patients treated with and without silver-based dressing, respectively. Therefore, silver-based 
dressing demonstrated a lower incidence of incisional SSI and improved primary healing in 
comparison with patients in whom conventional non-silver–based dressing has been used (Lawrie 
et al., 2022). 
While silver dressings offer significant benefits in wound management, their effect on median 
sternotomy wound infections in adult patients undergoing cardiac surgery  grafting at KFSHRC did 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
not report it. Therefore, the aim of this study is to assess the effect of the silver dressing on SSIs rates 
in adult patients post cardiac surgery.  
 
Objectives 
 
1. Assess the effectiveness of the silver dressing on SSIs rates as compared to the standard dressing- 
Mepilex foam dressing in reducing SSIs. 
 
 
Methodology 
May include: 1. Inclusion Criteria and Exclusion Criteria, which will be used in selecting the research participants; 
2. Registration, 3. Randomization Process, 4. Data gathering methods, 5. Procedures, Designated Central 
Laboratories, 6. Follow-up, 7. Safety and Efficacy Parameters, 8. Expected Outcome, 9. Sample Size, and 10. 
Statistical Methods. 
 
Research Design  
 
A single centre randomised control study approach will be followed.  
 
Research Setting and study population  
 
King Faisal Specialist Hospital and Research Center- Jeddah, a specialist referral and research 
center, which is a 390 bedded facility with three main domains of care namely Ambulatory Care 
(20 units), Nursing Speciality (13 departments), and Nursing General  Services (10 departments). 
Patients admitted to Cardiac surgical intensive unit (CSICU), Coronary Care Unit (CCU) and 
Cardiovascular Telemetry- Adult (CVT Adult) Unit after cardiac surgery with a sternal wound.  
In 2023 there was a total of 150 of adult cardiac patients admitted post cardiac surgery with a 
mediastinal incision.   
 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
Current cardiac SSI rates at KFSHRC-J 
 
SSIs currently are a challenge amongst cardiac surgical patients. The operational benchmarking 
for SSIs is 2.9 with an operational goal of 2.1. and with the current numbers of SSIs the organisation 
was not able to outperform the benchmark. The below graph depicts the rates of SSI for the years 
2022-2023.  
 
 
 
 
Despite defined interventions to reduce SSIs such as the Bundle of Care Interventions for the 
Prevention of Healthcare associated infections- CIPP 8834 - SSI Prevention Bundle, the SSI rates  for 
CABG and cardiac have soared in the latter part of 2023.  
 
Sampling technique  
Category 
Benchmark  Operational Goal  
Year to Date (2023) 
Year to Date (2022) 
No. of Procedur
es 
No. of Infecti
ons 
Rate 
No. of Procedu
res 
No. of Infections 
Rate 
CABG 
2.9 
2.1 
69 
4 
5.8 
134 
8 
5.97 
All cardiac   
2.1 
327 
4 
1.2 
734 
11 
1.5 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
The study will follow a randomised sampling approach. Randomisation will include: first patient 
transferred from OR to the  CSICU will be part of the intervention group, second patient part of the 
control group. This sequence will be followed until the required sample size is reached.  
Sample size will include: 
In the year 2023 there were a total of 200 patients admitted for a cardiac surgical procedure 
requiring a mediastinal incision. Based on this population and sample size calculation- a total of 
109 patients will be included – meeting the inclusion and exclusion criteria. 
Ie 55 in the intervention group and 54 in the control group. 
Inclusion criteria  
 
Patients 14 years of age and older scheduled for cardiac surgery requiring a sternotomy 
incision.  
Exclusion criteria  
 
Presence of a concurrent infection and any systemic antibiotic other than those used for the 
purpose of perioperative prophylaxis.  
 
Patients who died without an infection within 30 days following surgery. 
 
Patients who had undergone another procedure through the same incision(s) within a year 
after enrollment in this study. 
 
Patients who are a redo- such as needing debridement or an infection. 
 
Patients that have an open chest  
 
Patients on ECHMO  
 
Patients excessively bleeding  
 
Patients who require the surgery as an emergency  
 
Patients with a known allergy to silver dressings 
 
 
 
Current Practice  
 
Pre- operative  
 
2% Chlorhexidine bathing on the night before and morning of the operation 
 
Hair removed by clipping or other means of removal not more than one day prior to surgery  
 
Prophylactic antibiotic : Cefazolin 1g  

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
Blood glucose assessment -Insulin infusion protocol shall be initiated on unit for patient’s high 
blood glucose level >11.mmol (<200mg/Dl). 
 
Intraoperative  
 
2% chlorhexidine and 70% alcohol based solution for skin preparation shall be used 
immediately prior to incision 
 
Appropriate prophylactic antibiotic shall be administered as per formulary  
 
Glycemic control shall be maintained at blood glucose levels of <11 mmol (<200mg/Dl)  
 
 Patient Normothermia (> 36 centigrade) shall be monitored and maintained  
 
Antimicrobial re-dosing  
 
Postoperative  
 
Glycemic control shall be maintained at blood glucose levels of <11 mmol (<200mg/Dl)  
• Prophylactic antimicrobials (if prescribed) shall be discontinued after 48 hours of surgery. 
 
Wound dressing assessed for dry and intact  
 
Wound dressing is Mepilex Foam dressing  
 
The current practice related to choice of wound dressing is the Mepilex foam boarder, however 
the institution is in the process of introducing the silver dressing as part of standard practice. The 
silver dressing has been approved by the products co-ordinator in the organisation 
 
(Bundle of Care Interventions for the Prevention of Healthcare associated infections- CIPP 8834) 
Length of stay: 
.  
Patients’ typical length of stay: 
 
CSICU- 2.5-3.7 day 
 
CCU- 2 
 
CVT- 3 days  
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
INTERVENTION 
 
 
 
 
Assess for eligibility  
Randomisation  
Allocation  
Intervention 
n=  
Silver dressing - sternotomy wounds and donors sites 
1. Immediately after received from OR  
2. 7 days post-operative or when oversaturated. 
3. LOS- CSICU 3-4 days 
4. Transfer to CCU or CVT 3 days  
NB: Dressings and assessment for SSI will be managed 
accordingly in each of the respective units  
 
Control  
n= 
Mepilex Border Opsite dressing - sternotmy wounds and 
donor sites  
1. Immediately after received from OR  
2. 72 hrs after or when oversaturated 
3. LOS- CSICU 3-4 days 
4. Transfer to CCU or CVT 3 days  
NB: Dressings and assessment for SSI will be managed 
accordingly in each of the respective units 
 
Continuous assessment of signs of SSI following the CDC – SSI BUNDLE at KFSHRC-J 
 
Wound dressings will discontinue once the incision has epithelialised  
 
Data analysis  
 
Follow up with both groups at 30 days post procedure  

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
Description of intervention  
 
 
Intervention will consist of a replacement of the sterile plain postoperative dressing Mepilex border 
dressing (versatile five-layer all-in-one bordered foam dressing) with the sterile silver-impregnated 
dressing on 3 units: the CSICU, CVT. The dressing will be applied upon arrival in the CSICU directly 
on the incision after closure had been performed with sutures and/or staples and the Mepilex 
border. Dressings will be changed at seven (days) post-surgery (or sooner if oversaturated), and 
then changed whenever the dressing becomes saturated. Application of the dressing will be 
discontinued when the incision had epithelialized. There will be no changes in techniques or patient 
care, and no other changes of any kind (including surgeons) during the entire study period. 
Throughout the entire period of hospitalization, patients will be monitored for signs and symptoms 
of infection as per Center for Disease Control [CDC] guidelines ie is superficial, deep, organ space 
infection (CDC, 2010).  Patients will be followed for signs and symptoms of SSIs up to one month 
following surgical intervention. Surgical site infections will be identified through assessment present 
in chart reviews, clinic visits, readmission to a hospital, laboratory culture surveillance, and 
telephone interviews at the one month period.   
 
NB: The control group will have the Mepilex foam dressing. All other processes and care will be 
the same as the intervention group.  
 
Data collection will include a check-list with: 
1. Demographic  
2. Risk factors 
3. Antimicrobial prophylaxis pre, intraoperative and post-operative. 
4. Signs of wound infection following the CDC criteria  
5. Type of dressing  
6. Vital signs  
7. Severity of illness using Parsonnet score 
 
The checklist apart from the Parsonnet Score Checklist was developed by the research team. 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
The Modified Parsonnet Score checklist was developed as a preoperative score for adult cardiac 
surgery. The checklist is a validated, additive scoring system for predicting operative mortality risk 
in cardiac surgery (Parsonnet et al, 1989).  See appendix 1; Checklist for Data collection  
 
 
 
Data analysis  
 
Data analysis will be done using SAS software Descriptive statistics will include frequencies and 
percentages.  Comparisons between the 2 groups will include chi-square statistic for categorical 
variables and the t test for continuous variables. Logistic regression will be used to compare the risk 
of infection according to type of dressing and adjusting for patients’ characteristics.  
 
Ethical considerations  
Data will be collected after the necessary approval from Nursing Affairs and the Institutional Review 
Board. Participation in this study is voluntary and no incentives will be given for participating. 
Participants are free to withdraw from the study at any point without penalty or risk to the treatment 
they were entitled to. Information regarding this research study will be offered to the participants 
in the study both verbally and in the form of an information document and informed consent.  All 
participants in the research study will be selected according to research requirements and treated 
equally and fairly throughout their participation.  Right to privacy and anonymity will be maintained 
by not linking any personal identification to any of the checklists and all research information will 
not be traceable back to individuals. Only the researchers will have access to the data, which will 
be kept on a computer with a password and will be destroyed after five years. 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
 
 
5. WORK PLAN AND RESPONSIBILITIES 
 
A detailed description of the protocol work plan is mentioned in the original documentation.  
Please refer to the submitted documents. The following Table summarizes the job responsibilities  
of involved members: 
 
  
 
 
6. REFERENCES  (comprehensive literature review) 
 
Centres for Disease Control and Prevention. (2010). National Healthcare Safety Network: surgical 
site infection (SSI) event. 2014-01-01 [2014-03-25]. http://www, cdc. gov/nhsn/pdfs/psc-
manual/9pscssicurrent, pdf. 
 
 
Cooper R, Kirketerp-Moller K.(2018). Non-antibiotic antimicrobial interventions and antimicrobial 
stewardship 
in 
wound 
care. 
J 
Wound 
Care, 
27(6):355-377. 
https://doi.org/10.12968/ 
jowc.2018.27.6.355.  
 
Dissemond J, Bottrich JG, Braunwarth H, Hilt J, Wilken P, Munter KC. (2017). Evidence for silver in 
wound care—meta-analysis of clinical studies from 2000-2015. J Dtsch Dermatol Ges., 15(5):524-
535. https://doi.org/10.1111/ddg.13233. 
 
Harder, E. E., Gaies, M. G., Yu, S., Donohue, J. E., Hanauer, D. A., Goldberg, C. S., & Hirsch, J. C. 
(2013). Risk factors for surgical site infection in pediatric cardiac surgery patients undergoing 
delayed sternal closure. The Journal of thoracic and cardiovascular surgery, 146(2), 326-333. 
 
Hastalarının HEUYC. (2019). The Care Needs and Care Dependency of Coronary Artery Bypass 
Graft (CABG) Patients After Hospital Discharge. Hem¸sirelik Egitim Ara¸st Derg,16(1):8–14. 
https://doi.org/10.5222/HEAD.2019.008. 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
King, M., Stambulic, T., Hassan, S. M. A., Norman, P. A., Derry, K., Payne, D. M., & El Diasty, M. (2022). 
Median sternotomy pain after cardiac surgery: To block, or not? A systematic review and meta‐
analysis. Journal of Cardiac Surgery, 37(11), 3729-3742. 
 
Lawrie, K., Waldauf, P., Baláž, P., Drozd, J., Brat'ka, P., Loveček, M., Klos, D.,  Skalický P, Peňázová 
Kurečková P, Kráčmar O, Kala Z. (2022). Silver-Based Dressings in the Prevention of the Incisional 
Surgical Site Infection: A Prospective Multicenter Observational Controlled Trial. Surgical 
Infections, 23(7), 682-690. 
 
Li HZ, Zhang L, Chen JX, Zheng Y, Zhu XN. (2017). Silver-containing dressing for surgical site infection 
in clean and clean contaminated operations: a systematic review and meta analysis of 
randomized controlled trials. J Surg Res., 215: 98-107. https://doi.org/10.1016/j.jss.2017.03.040.  
 
 Magnussen, C., Ojeda, F. M., Leong, D. P., Alegre-Diaz, J., Amouyel, P., Aviles-Santa, L., De 
Bacquer, D., Ballantyne, C. M., Bernabé-Ortiz, A., Bobak, M., Brenner, H., Carrillo-Larco, R. M., de 
Lemos, J., Dobson, A., Dörr, M., Donfrancesco, C., Drygas, W., Dullaart, R. P., Engström, G., … 
Blankenberg, S. (2023). Global Effect of Modifiable Risk Factors on Cardiovascular Disease and 
Mortality. The 
New 
England 
journal 
of 
medicine, 389(14), 
1273–1285. 
https://doi.org/10.1056/NEJMoa2206916 
 
Oliverius M, Drozd J, Bratka P, Whitley A, Mohlenikova Duchonova B, Gürlich R (2022). A new silver 
dressing, StopBac, used in the prevention of surgical site infections. Int Wound J,19:29–35. 
https://doi.org/10.1111/ iwj.13593 
 
Parsonnet, V., Dean, D., & Bernstein, A. D. (1989). A method of uniform stratification of risk for 
evaluating the results of surgery in acquired adult heart disease. Circulation, 79(6 Pt 2), I3-12. 
 
Phoon, P. H. Y., & Hwang, N. C. (2020). Deep sternal wound infection: diagnosis, treatment and 
prevention. Journal of cardiothoracic and vascular anesthesia, 34(6), 1602-1613. 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
Pivoto FL, Lunardi Filho WD, Santos SSC, Almeida MA, Silveira RS. Nursing diagnoses in patients in 
the postoperative period of cardiac surgery. Acta Paul Enferm [Internet]. 2010 [cited 2017 Jan 
17];23(5):665-70. Available from: http://www.scielo.br/pdf/ape/v23n5/en_13.pdf 
 
Seidelman, J. L., Mantyh, C. R., & Anderson, D. J. (2023). Surgical site infection prevention: a review. 
JAMA, 329(3), 244-252. 
 
Slamborova I, Zajicova V, Karpiskova J, Exnar P, Stibor I.(2013).  New type of protective hybrid and 
nanocomposite hybrid coatings containing silver and copper with an excellent antibacterial effect 
especially 
against 
MRSA. 
Korean 
J 
Couns 
Psychother., 
33(1):265-273. 
https://doi.org/10.1016/j.msec.2012.08.039.  
 
Vieira ALG, Stocco JGD, Ribeiro ACG, Frantz CV (2018). Dressings used to prevent surgical site 
infection in the postoperative period of cardiac surgery: integrative review. Rev Esc Enferm USP, 
52:e03393. DOI: http://dx.doi.org/10.1590/S1980-220X2017011803393 
 
Walker M, Parsons D. (2014). The biological fate of silver ions following the use of silver-containing 
wound care products—a review. Int Wound J., 11(5):496-504. https://doi.org/10. 1111/j.1742-
481X.2012.01115.x. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
7.  BUDGET SHEET 
 
personnel  
(name) 
position on 
project 
%  
time 
gr/step 
year 1 
year 2 
 
 
 
 
 
 
A) total for personnel:  
SR 
SR 
 
 
 
 
 
 
equipment (use a separate sheet if required) 
Year 
 
 
 
B) total for equipment:  
 
SR 
SR 
 
 
 
 
 
 
supplies and materials (use separate sheet if required) 
YEAR 
 
 
 
C) Total for materials and supplies:  
 
SR 
SR 
 
 
 
 
 
 
other expenses (use separate sheet if required) 
Amount 
category 
purpose 
 
 
 
 
 
 
 
 
 
 
 
 
D) Total for other expenses:  
 
SR 
SR 
 
 
 
 
 
 
TOTAL BUDGET (A  D) 
SR 
SR 
 
Suggested Sources of External Funding 
Company 
Address 
Relationship to research proposal 
None 
 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
 
8.  Pharmacy Information Sheet  (page 1 of 2) 
                                                    
Title of the Proposal:      
 
 
IRB #: (if available)  _______________   Principal Investigator:  ___________________________ 
 
 
 
Drug Name 
 
 
 
 
 
 
 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
 
Dose 
 
 
 
 
 
 
 
 
 
 
 
 
Administration Route 
 
 
 
 
 
 
 
 
 
 
 
 
Administration 
Frequency 
 
 
 
 
 
 
 
 
 
 
 
Length of Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
Drug Status* 
 
 
 
 
 
 
 
 
 
 
 
 
Number of Patients 
 
 
 
 
 
 
 
 
 
 
 
 
Provider: Hospital or 
Sponsor (Identify sponsor) 
 
 
 
 
 
 
 
 
 
 
 
Total Drugs Required 
(Pharmacy will calculate) 
 
 
 
 
 
 
 
 
 
 
 
 
(For Pharmacy Use) 
medication Cost 
 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
Rou 
Exp 
 
Research Pharmacist 
time 
 
 
 
 
_________ 
(hrs) X 
 
_________ 
SR/hr 
 
= SR  
_________ 
 
2 
If this is a randomized study, who is responsible for Randomization?  
                             
 
3 
Over what period of time do you intend to accrue the patients?  
* 
The Pharmacy Department must seek approval through the MOH in order to import drugs.  Approval of the 
proposal by the IRB does not guarantee that the drugs will be approved by the MOH.  Being a registered or 
investigational drug in any of the five reference countries (USA, Canada, UK, Sweden, Saudi Arabia) would 
help in obtaining MOH approval. 
 
 
Please use the following abbreviations:  HF – on Hospital formulary; MOH – registered by the Saudi Ministry 
of Health; USA – registered in USA; CA – registered in Canada; UK – registered in UK; SW – registered in 
Sweden; USAI – being investigated in USA; CAI – being investigated in Canada; UKI – being investigated 
in UK; SWI – being investigated in Sweden. 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
Pharmacy Information Sheet (page 2 of 2)                                            
 
 
Title of the Proposal:      
 
 
IRB#: (if available)  _______________  Principal Investigator:   
 
 
This part is to be completed by the Pharmacy Department:  
       ( Check ()  appropriate box(es) and complete) 
 
 The Pharmacy Department has assigned a Research Pharmacist to provide information and assistance in the 
conduct of this proposal.  If you have any questions, please call the Office of the Institutional Review Board 
at extension 2984. 
 
 
The Pharmacy department will provide the following: 
 
I. 
  Drug keeping and dispensing 
 
II.   Preparation of Drug 
 
III.   Drug Information (physician, nurse, pharmacist, etc) 
 
IV.   MOH permit for import, release from customs 
 
V.   Patient counseling for drug information, compliance, medication handling, and return of  
unused products (if required) 
 
VI.    Maintain and submit to IRB, upon completion/termination of the study, investigational drug records of: 
(a) inventory, delivery to KFSH&RC: Date, amount, lot #, expiration date, etc. 
(b) use by each study subject 
VII.  Follow the trial randomization procedure 
VIII. Supply the drugs listed on page 1 of this form 
 
 Pharmacy Department will be happy to provide the above, provided the following issues have been 
satisfactorily addressed: 
 
 
 
1. 
 
2. 
 
3. 
 
 The Pharmacy Department will not be able to assist with this project due to the following: 
 
 
________________________________________________________________________________________ 
 
__________________________________________________________________________ ____________ 
 Total Pharmaceutical cost (routine care) _______ SR    Total Pharmaceutical cost (experimental) _______ SR 
 
 
9.  BIOLOGICAL HAZARDS 
This form page completed by: 
 
Name (print) ______________________________   Signature: _______________________  Date:  _____________ 
 
Approved by: ______________________________  Signature: _______________________  Date: _____________ 
                        (Head of Pharmacy Department) 
 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
                                                          
Title of the Proposal:      
                                                                                                                                                                                                   
 
Does the proposed research involve any toxic chemical?   
 
1. Please name chemicals and describe the nature of the hazard involved: 
 
_______________________________________________________________________________________ 
 
______________________________________________________________________________________ 
 
 
2.  Does the proposed research involve any hazardous micro-organism?  
 
If yes, name the organisms and describe the nature of hazards expected. 
 
_______________________________________________________________________________________ 
 
_______________________________________________________________________________________ 
 
 
 
Also describe facilities, safety measures and procedures to protect personnel and environment. 
             
_______________________________________________________________________________________ 
 
_______________________________________________________________________________________ 
 
 
3.  Does the proposed research involve radioactive materials?  
 
If yes, describe the materials, half-life and methods of disposal and personnel protection. 
 
_______________________________________________________________________________________ 
 
_______________________________________________________________________________________ 
 
 
4. Does the proposed research involve recombinant DNA?   
 
If yes, are you familiar with NIH guidelines and do you have the containment facilities?  _________ 
 
Describe the nature of genes to be cloned, organisms and plasmids to be used. 
 
_______________________________________________________________________________________ 
 
_______________________________________________________________________________________ 
 
 
 
10. Informed Consent 
    for research involving the administration of drugs, use of devices 

 
Principal Investigator: 
 
 
Name (print       Signature: ______________________ Date:   
 
 
 
February 16 2024 
 
 
 
 
 
 
 
 
            or performance of procedures  
 
         for research with no direct benefit to participant