Postoperative Orthopedic Wound Dressing Using Sterile Versus Clean Non-sterile Techniques At Hamad General Hospital. A Prospective Pilot Study
Phase: NA
Conditions: Surgical Site Infection (SSI)
Sponsor: Hamad Medical Corporation

 
MRC-01-20-272  Validity: 11 11 2020 - 10 11 2021 E-stamped 11 Nov 2020 
HMC RESEARCH  
PROTOCOL   
  
Study Title:  
Orthopedic Wound Dressing Using Sterile Versus Clean Non-sterile 
Techniques At Hamad General Hospital.  
Prospective Pilot Study  
Principal Investigator:  
Dr. Ghalib Ahmed    
Contents  
  
1. 
Synopsis 
............................................................................................................................................. 2  
2. 
Abbreviations and Acronyms 
............................................................................................................ 2  
3. 
Introduction / Background 
................................................................................................................. 3  
4. 
Objectives 
.......................................................................................................................................... 4  
5. 
Indicate if this is a retrospective data review 
.................................................................................... 4  
6. 
Study Methodology 
........................................................................................................................... 4  
7. 
Study Population and Study Setting/ Location 
.................................................................................. 5  
8. 
Study procedures 
............................................................................................................................... 7 Study 
Duration and Timelines .............................................................................................................. 7 
Informed Consent 
................................................................................................................................. 7  
Risk ....................................................................................................................................................... 7 
Bio-Specimens & Sample Collection ................................................................................................... 8 
Outcomes .............................................................................................................................................. 8 
Data Collection & Confidentiality ........................................................................................................ 8  
Subject Withdrawal/ Withdrawal of Consent 
....................................................................................... 9  
9. Statistical Consideration and Data Analysis 
..................................................................................... 9  
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10. 
Adverse Event Reporting ............................................................................................................... 
9  
11. 
Ethical Consideration ..................................................................................................................... 
9  
12. 
Sponsor, Funding & Collaborator Information ........................................................................... 
10  
13. 
Dissemination of Results and Publication policy ........................................................................ 
10  
14. 
References .................................................................................................................................... 
10 15. Appendices 
.................................................................................................................................. 10   
  
  
  
Page 1 of 16  
 
1. Synopsis  
  
    
  
  
   
   
Surgical site infection (SSI) is a serious complication in patients 
undergoing orthopedic procedures.   
  
SSI can be defined by the presence of microorganisms in sufficient quantity 
that may lead to tissue injury or delayed wound healing. It can be divided 
into acute (superficial) and chronic (deep), which may occur 
postoperatively up to 30 days and 12 months, respectively.  
  
Following orthopedic procedures, the use of sterile or clean non-sterile 
technique for wound care and dressing varies widely. However, there is 
no evidence in the literature to determine which technique is more 
effective in preventing acute SSI.   
  
Sterile (aseptic) technique implies the use of a sterile gloves, sterile field 
and sterile equipment. Clean non-sterile technique implies the use of a 
clean non-sterile gloves, sterile field and equipment.  
  
Hamad Medical Corporation (HMC) wound care policies do not 
recommend whether to use sterile or clean non-sterile technique for 
wound care and dressing after major orthopedic procedures such as joint 
replacement and reconstructive surgery.  
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Considering the need for evidence-based practice, this study aims to 
evaluate the rate of acute SSI following elective orthopedic procedures in 
the aforementioned techniques.  
  
  
  
3. Abbreviations and Acronyms  
 SG : Sterile Gloves   
   
NSG : Non-sterile Gloves  
 SSI : Surgical site infection   
   
5. Introduction / Background  
  
  
  
SSI following orthopaedic surgeries is not uncommon. If an infection 
occurs, it may lead to debilitating results, increased reoperations, hospital 
stay, and healthcare costs [1].  
  
SSI was defined by the Centres for Disease Control and Prevention/ 
National Nosocomial Infections Surveillance system. The definition 
included superficial and deep SSI with an onset within 30 days and 12 
months, respectively, following the operation [2].   
  
Because there is no current standard of care to use sterile or clean 
nonsterile technique for wound care and dressing following elective 
orthopaedic procedures, further studies are needed to determine which 
technique is more effective in preventing acute SSI [3,4].  
  
The sterile technique was defined in a systematic review by Kent by the 
use of sterile field, sterile gloves, and sterile instruments. Whereas clean 
technique implies the use of a clean procedure field, clean non-sterile 
gloves and ensuring that the gloves, field, and supplies are free of 
contamination [3].  
  
Some studies have compared the use of sterile and clean non-sterile 
techniques to determine the effect on wound infections in cutaneous 
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surgical procedures and chronic wounds [4,5,7]. Ghafouri et al.[1] 
reported the SSI rate of 2.02% and 4.6% in patients underwent 
contaminated laceration wound repair using sterile and clean non-sterile 
techniques, respectively.  The incidence of infection was not significantly 
different between the two groups.   
  
A Systematic Review and Meta-analysis have concluded that there was no 
difference in the rate of infection between outpatient surgical procedures 
performed with sterile versus non-sterile gloves [3,5]. Other studies 
concluded that each health care organization has to establish its own 
guidelines for wound care because the existing evidence base does not 
support the preferential selection of either technique [6]. A prospective 
randomized controlled study had concluded that clean non-sterile gloves 
are not inferior to sterile gloves for minor skin excisions in general 
practice regarding SSI [7].  
  
To the best of our knowledge, there are no studies available that have 
compared the rate of acute postoperative SSI between the use of sterile 
versus clean non-sterile gloves for wound care and dressing after knee 
arthroscopy, ACL repair (infection rate is low (0.14%-1.7%) following 
ACL reconstruction) [19] or simple isolated fracture fixation. This pilot 
study aims to evaluate the rate of acute SSI following this orthopedic 
procedures in sterile versus clean non-sterile techniques.  
  
  
   
 
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7. Objectives  
   
  
Hypothesis:  
  
No difference in the rate of SSI between the use of sterile or clean non-sterile 
techniques following knee arthroscopy, ACL repair or simple isolated fracture 
fixation for wound care and dressing.   
  
  
Primary Objective:   
To compare the rate of significant SSI within the 6 weeks following orthopedic 
procedure between both techniques. (Significant SSI which needs treatment with 
antibiotics or further management, eg: wound debridement.)  
  
Secondary Objectives:  
Hospital stay and need for readmission.   
Need for second operation or treatment.  
To compare the cost of dressing changes.  
   
  
  
   
 
8. Study Methodology   
    
  
Study design: Randomized prospective pilot study  
  
Sample size: Since limited data is available to calculate sample size, 
especially from the orthopedic surgery field, we will recruit 100 patients 
with 50 patients being in each group. Then we will do a post hoc analysis 
to calculate the adequacy of sample size to adjust the sample size according 
to 80% power with less than 20% type 2 error and less than 5% P-value.[15]  
  
Method:  
  
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The study will be designed as a prospective pilot study to compare the rate of 
acute SSI up to 6 weeks following knee arthroscopy, ACL repair or simple 
isolated fracture fixation between the use of sterile versus clean non-sterile 
techniques for wound care and dressing. The main reason behind this design is 
that no previous studies reported the rate of acute SSI following the 
aforementioned procedures.  
  
All patients will be treated using the same postoperative protocol. Dressing 
will be changed once by the one specialist nurse practitioner on day 5 after the 
procedure. Patients will be assessed in the outpatient clinic on day 14 for 
dressing changes and for suture removal. The final assessment will be at the 
outpatient visit on week six postoperatively.  
  
The study is limited to procedures done by one nurse only when the patient is 
in the hospital or in the clinic.  
  
Adult patients (age >= 18) who will undergo clean knee arthroscopy, ACL 
repair or isolated fracture fixation at our orthopaedic surgery ward will be 
screened for recruitment. Patients who meet the inclusion criteria and are 
willing to participate in the study will be asked to sign a consent form. Once a 
patient is eligible for recruitment, informed consent will be obtained. The 
randomization sequence will be generated beforehand and the allocated 
treatments will be in sealed opaque envelopes. A sealed envelope will be 
opened and the allocated treatment will consist of either dressing change with 
the use of sterile or clean non-sterile technique during the post-operative 
course. Neither patients nor the research team will be blinded for dressing type.   
  
  
  
Baseline variable that will be collected includes:  
• 
Patient demographics   
• 
Type of elective orthopaedic procedure  
• 
Duration of the operation  
• 
Estimated blood loss  
• 
Number of dressing changes and any days   
• 
Preventive measure such as pre-op staph aureus decolonization, dental 
check-up, hair removal, nutrition status will be screened before the surgery.   
  
For patients in both groups, World Health Organization (WHO) Hand 
Hygiene Technique with Soap and Water will be implemented [8]. Then the 
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use of one pair of clean non-sterile gloves during the opening of the dressing. 
The skin will be disinfected with a chlorhexidine stick. Depending on the 
patient treatment allocation, a sterile or clean non-sterile technique (using 
sterile to sterile procedure when handling materials and supplies for sterile 
technique) will be utilized for dressing application.  
  
Patients will be followed during the hospital stay, 2 weeks and 6 weeks after 
the procedure. At each follow-up visit, SSI indicators will be collected. Lab 
test will be done only for patient with high clinical impression of infection, as 
part of routine patient care. White blood cell count, c-reactive protein and 
wound culture will obtained in patient who have clinical indications of SSI.  
  
We will document any other operative complications and reoperations during 
the postoperative 6 weeks as well.  
  
Dressing type will be changed using Mepilex Border Flex 7.5*7.5   
  
  
We will use the below questioners to detect the rate of significant SSI [14]:   
  
 Fever (>38.0°C [>100.3°F]) at presentation with 
clinical assessment   
 Wound Assessment (Impression)  
0 - No or slight erythema (No evidence of infection)  
1 - Erythema not >1 cm from the suture line ( Slight inflammation does not require 
antibiotics)  
2 - Erythema >1 cm from suture line ±edema (Significant infection requires antibiotics)  
3 - Pus ±1 or 2 (Severe infection requires an immediate referral for exploration and 
debridement + antibiotics)  
  
SSI with be considered significant in 2 and 3.  
  
  
  
   
10. Study Population and Study Setting/ Location  
   
  
Study Setting:   
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Orthopedic surgery ward, Hamad General Hospital.  
  
Eligibility criteria: [17]  
Age more than 18 and less than 65 years  
knee arthroscopy, ACL repair or isolated 
fracture fixation.  
Operating time < 2 hours   
Patients with ASA 0 to ASA1   
Non smoker   
No previous surgical scar in the knee   
Informed consent   
  
Any patient that has, previous superficial or deep infection at the site of surgery, 
polytrauma, transfusion of blood products, obesity (BMI > 40 kg/m^2), diabetes 
mellitus, revision procedure or immune-compromised, patient preparationrelated 
factor  (inadequate antiseptic skin preparation, preoperative hair removal), skin 
disease, current use of antibiotics instructed by the treating physician (eg, 
contaminated wounds) will be excluded.   
  
  
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12. Study procedures   
   
Total Study duration: 12 months  
  
Task  
Timepoint  
Study preparation  
1 Month   
Recruitment and follow-up  
6 Months   
 
Final Statistical Analyses  
3 Months   
Publication in relevant journals  
2 Months  
  
  
  
  
  
  
Informed Consent  
  
 Adult patients (age >= 18) who underwent knee arthroscopy +\- ACL repair will 
be invited postoperatively by the research team to take part in the trial.  Patients 
will have 24 hours to decide whether they want to participate or not.   
   
  
Risk  
  
Since the literature shows no difference in the incidence of SSI in other fields, we 
expected a relative risk for both techniques. Moreover, we may conclude which 
technique is better and help introduce a new policy for future practice in HMC.    
   
  
Bio-Specimens & Sample Collection  
  
 Wound culture   
Blood tests including a white blood cell counts, C-reactive protein and 
Procalcitonin.  
  
  Outcomes   
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 The primary objection is to compare the rate of acute SSI between the use of 
sterile and clean non-sterile techniques for post-operative orthopedic wound 
care.   
  
Data Collection & Confidentiality   
  
Data and medical record will be stored on a separate data spread sheets  
The study data will be only accessible by the research team members, to prevent 
privacy breach.  
Data will be protected with password encryption and will be stored on an online drive 
using Microsoft OneDrive.  
The Data spreadsheet will be physically stored at a computer in the orthopedic 
surgery department in Hamad General Hospital.  
Data identifiers will be destroyed after we complete data collection and validation. The 
de identified study data will be stored for 5 years after study completion.  
  
 The following data will be collected on a spreadsheet:  
• Demographic data (Age ,gender, BMI )  
• Comorbidities: (DM, HTN)  
• Type of procedure  
• Hospital course (TICU admission)   
• Transfusion of PRBC  
• Clinical signs of infection:   
o Vital signs (Temperature, Heart Rate ) o 
Signs of Infection   
-Purulent discharge  
-Pain or tenderness  
-Localized swelling  
-Redness or heat at site  
-Lab tests in cases with significant SSI ( WBCs > 14.0 K/ml, C-Reactive 
Protein > 18.5 mg/ml , Procalcitonin > 187.5 pg/ml) [6].  
-Positive Wound Culture.  
  
  
Subject Withdrawal/ Withdrawal of Consent  
Patients have the right to withdraw from the study at any time point. This will 
not affect their care in anyway. We will ask the withdrawing patients if we can 
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publish and use the data we collected up to the point of withdrawal. If the 
patient refuses to share any of the data, we will delete it permanently.  
  
  
   
 
14. Statistical Consideration and Data Analysis  
  
  
 Stata statistical package 15.1IC will be used for statistical analyses. The primary   
outcome and secondary outcomes that are nominal ( categorical ) will be 
analyzed in both groups using a chi-square test or the Fischer exact test. The 
statistical analysis will be carried out by a biostatistician from HMC MRC.  
  
Categorical data will be expressed as proportions, and continuous data will be 
presented as mean with standard deviation (SD) for normally distributed 
variables or as medians (interquartile range, IQR) for non-normally distributed 
variables.   
Unpaired t or Mann Whitney U tests will be applied to compare quantitative data 
and outcomes (such as length of hospital stay, BMI etc. ) between SSI and non-
SSI groups .   
• In addition, exploratory statistical analyses using logistic regression method 
will be performed to assess and explore various potential factors and covariates 
that might affect SSI rate.   
• All P values presented will be two-tailed, and P values <0.05 will be 
considered as statistically significant. All Statistical analyses will be done using 
statistical packages SPSS 23.0 (SPSS Inc. Chicago, IL) and Epi-info (Centers 
for Disease Control and Prevention, Atlanta, GA) software.   
  
  
  
16. Adverse Event Reporting  
  
Since the literature shows no difference in the incidence of SSI in other fields, we 
expected a relative risk for both techniques. Moreover, we may conclude which 
technique is better and help introduce a new policy for future practice in HMC.    
  
 1-Adverse event (AE):  
   
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An AE is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in 
patients.  
  
2-Serious adverse event (SAE)  
A SAE is defined as any AE that:  
• Led to death  
• Led to a serious deterioration in health of the patient that either resulted in  
a life-threatening illness or injury, or  
 a permanent impairment of a body structure or a body function, or  
 inpatient or prolonged hospitalization, or  
 a medical or surgical intervention to prevent life-threatening illness or 
injury or permanent  
 impairment to a body structure or a body function  
3-Adverse event documentation  
The following information is collected:  
 Name and description of the event  
 Start date of the event (if applicable)  
 Actions taken due to the occurrence of the event  
 Outcome of the event  
 Date the patient has recovered from the event  
 Relationship to treatment under investigation  
 Severity of the event  
 Seriousness of the event  
  
  
4-As soon as a research team member becomes aware of an SAE, this person 
will ensure that the following people will be notified:  
 PI  
 MRC/IRB  
  
5-The following steps need to be taken after a study patient has experienced an 
SAE:  
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Initial SAE report:   
  
The investigator collects as much of the following information as possible for 
reporting to MRC/IRB:  
 Subject demographics  
 Date of occurrence of the event  
 Description of the event, including severity and relationship to the treatment  
 Possible cause of SAE other than the investigational device  
 Relevant medical history  
 Relevant test/laboratory data  
 Concomitant medications  
 Name and contact details of the person who has reported the event.  
  
6- Follow up of adverse events  
  
Each AE will be followed up until resolved with or without persistent damage or 
until the end of the patient’s study participation. All patients experiencing an AE 
must be monitored until the symptoms subside and any clinically relevant 
changes in laboratory values have returned to baseline, or until there is a 
satisfactory explanation for the changes observed.  
  
18. Ethical Consideration  
  
 Ethical approval will be obtained from Hamad Medical Corporation Institutional   
Review Board prior to initiating the study. All study personnel will adhere to GCP 
guidelines and the rules and regulations set by the Ministry of Public Health in 
Qatar.   
  
20. Sponsor, Funding & Collaborator Information   
  
  
  
   
Hamad Medical Corporation fund for publication and conference fees.  
22. Dissemination of Results and Publication policy  
  
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 The research team will work on publishing the results in regional and international   
Journal, upon completion of the study. Moreover, the study material will be served 
for educational purposes.  
24. References   
  
2. Al-Mulhim, F., Baragbah, M., Sadat-Ali, M., Alomran, A. and Azam, M., 2014.   
Prevalence of Surgical Site Infection in Orthopedic Surgery: A 5-year Analysis. 
International Surgery, 99(3), pp.264-268.  
  
3. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of 
surgical site infection, 1999. Hospital Infection Control Practices Advisory 
Committee. Infect Control Hosp Epidemiol 1999;20:250–78 [quiz 79–80].  
  
4. Kent, D., Scardillo, J., Dale, B. and Pike, C., 2018. Does the Use of Clean or 
Sterile Dressing Technique Affect the Incidence of Wound Infection?. Journal 
of Wound, Ostomy and Continence Nursing, 45(3), pp.265-269.  
  
5. Brewer JD, Gonzalez AB, Baum CL, et al. Comparison of Sterile vs Nonsterile  
Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures: A 
Systematic Review and Meta-analysis. JAMA Dermatol. 2016;152(9):1008– 
1014. doi:10.1001/jamadermatol.2016.1965.  
  
6. Gray, M., 2001. Clean versus sterile technique when changing wound dressings. 
Journal of WOCN, 28(3), pp.125-128.  
  
7. VsevolodS.Perelman, Gregory J.Francis, Tim Rutledge, John Foote, Frank 
Martino, George Dranitsaris. Sterile versus nonsterile gloves for repair of 
uncomplicated lacerations in the emergency department: A randomized 
controlled trial. Annals of Emergency Medicine. Volume 43, Issue 3, March  
2004, Pages 362-370. https://doi.org/10.1016/j.annemergmed.2003.09.008  
  
8. Heal, C., Sriharan, S., Buttner, P. and Kimber, D., 2015. Comparing non‐sterile 
to sterile gloves for minor surgery: a prospective randomised controlled 
noninferiority trial. Medical Journal of Australia, 202(1), pp.27-31.  
  
9. World Health Organization. WHO guidelines on hand hygiene in health care: a 
summary. Geneva: WHO, 2009.  
http://www.who.int/gpsc/5may/tools/who_guidelineshandhygiene_summary.pd
f (accessed Apr 2014).  
  
10. Saleh, R., Youssef, A. and Demerdash, H., 2017. Diagnostic value of serum 
procalcitonin compared with c-reactive protein for postoperative wound 
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infection of surgically treated trochanteric fracture. Research and Opinion in 
Anesthesia and Intensive Care, 4(3), p.164.  
  
11. Journal of Wound, Ostomy and Continence Nursing. Issue: Volume 39(2S)  
Supplement 2S, March/April 2012, p S30-S34. Updated/Revised: WOCN 
Wound Committee, 2011. DOI:10.1097/WON.0b013e3182478e06  
  
12. Clare Heal, ShampaviSriharan, Petra G Butter, Deborah Kimber. Comparing 
non‐sterile to sterile gloves for minor surgery: a prospective randomised 
controlled non‐inferiority trial. Medical Journal of Australia Volume 202, Issue  
1. First published: 19 January 2015. https://doi.org/10.5694/mja14.00314  
  
13. Hughes KA, Cornwall J, Thais JC, Brooks HJ. Bacterial contamination of 
unused, disposable non-sterile gloves on a hospital orthopedic ward. Australis 
Med J. 2013;6(6):331-8. Published 2013 Jun 30. doi:10.4066/AMJ.2013.1675  
  
14. The Epidemiology of Wound Infection: A 10-Year Prospective Study of 62,939 
Wounds Author links open overlay panelPeterJ.E.CruseM.B., F.R.C.S., 
F.A.C.S.*RosemaryFoordR.N.  
  
15. Perelman, V., Francis, G., Rutledge, T., Foote, J., Martino, F. and Dranitsaris, 
G., 2004. Sterile versus nonsterile gloves for repair of uncomplicated 
lacerations in the emergency department. Annals of Emergency Medicine, 43(3), 
pp.362-370.  
  
16. Whitehead, A., Julious, S., Cooper, C. and Campbell, M., 2015. Estimating the 
sample size for a pilot randomised trial to minimise the overall trial sample size 
for the external pilot and main trial for a continuous outcome variable. 
Statistical Methods in Medical Research, 25(3), pp.1057-1073.  
  
17. A prospective clinical audit of patient dressing choice for post-op arthroscopy 
wounds. Mayukh Bhattacharyya, Helen Bradley, Sian Holder, Bruno Gerber.  
  
18. Prolonged operative duration is associated with complications: a systematic 
review and meta-analysis Hang Cheng, MSc,a,* Jeffrey W. Clymer, PhD,a 
Brian Po-Han Chen, ScM,a Behnam Sadeghirad PhD,b Nicole C. Ferko, MSc,b 
Chris G. Cameron, PhD,b and Piet Hinoul, Mda  
  
19. Infections in Anterior Cruciate Ligament Reconstruction Charlton Stucken, 
MD,† David N. Garras, MD,† Julie L. Shaner, MD,† and Steven B. Cohen,  
MD*†  
  
  
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26. Appendices  
Data Collection sheet (uploaded with research proposal on Abhath.hamad.qa)   
  
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