Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial
Phase: PHASE4
Conditions: Pressure Injury, Pressure Injury Stage 2, Bedsore, Pressure Ulcers Stage II, Pressure Ulcer, Buttock
Sponsor: King Abdullah Medical City

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
 
Project Title:  
Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in 
treatment of second stage pressure ulcer: A randomized control clinical trial. 
 
Acronym 
 
Version: version: 5 (28/3/2023) 
 
 
Principal Investigator: Ebtisam Abdellatif Ebrahim  
 
Sponsor: King Abdullah Medical City in Holy Capital 
 
Introduction 
 
 A pressure ulcer (PU) is a local skin injury caused by pressure or a combination of pressure and 
tensile forces on the bony prominences. The sacrum, hips, and heels are the most common sites for pressure 
ulcer. Within 2 to 6 hours of applying pressure to the tissue, pressure ulcers start to form. As a result, it 
should be avoided by keeping the pressure on the tissue capillaries below 30 mmHg [1,2]. 
Age, poor nutrition, reduced mobility, decreased body mass, anemia, hypoalbuminemia, friction, 
impaired sensory awareness, a history of pressure ulcers, smoking, and a lack of vitamins A, C, and E 
are contributing factors in the development of pressure ulcers [3]. 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
Pressure ulcers can be avoided by changing the patient's position every two hours, cleaning the 
area around the wound, and avoiding coming into contact with their urine or feces. Additionally, a daily 
evaluation of the wound's location, size, depth, and smell should be made. It's also important to note any 
scarring, infections, necrosis, and necrosis smells. To prevent bacterial growth, debridement should be 
done if necessary [4]. 
Pressure ulcers require significant costs on both the health care system and patients [5]. In 
addition to the gangrene and cellulite-related pain and suffering, these wounds have the potential to 
result in amputation, diminished quality of life, and even death [6]. Pressure ulcers can be treated in a 
number of ways, including wound cleaning, debridement, improved dressings, patient optimization, 
antibiotics, and reconstructive surgery. Additionally, more recent alternatives for treatment are offered, 
including cell therapy, hyperbaric oxygen therapy, and negative pressure wound therapy [7]. 
Pressure ulcers have been treated in China using traditional Chinese remedies such as herbal 
medicinal ointments, particularly Moist Exposed Burn Ointment (MEBO), acupuncture, and 
moxibustion [8–10]. MEBO was successfully used to treat burns in clinical settings in earlier 
investigations. It consists of sesame oil, b-sitosterol, berberine, and other Chinese herbal plant 
ingredients [11]. 
Additional clinical and experimental research has revealed that MEBO not only has analgesic 
and antibacterial benefits but can also hasten the healing process for burn wound patients [12–15]. 
Additionally, it can either promote debridement and epithelial repair or lower treatment expenses for 
patients and their families [11,16]. MEBO has also reportedly been shown to aid in the healing of 
neurogenic and chronic ischemic ulcers [12,15]. 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
Topical zinc oxide aids in the re-epithelialization process, which is important for wound healing. 
Clinical research has shown that people with low zinc levels had slower healing of ulcers [17], and zinc 
can be administered topically or orally to help these patients recover more quickly [18]. 
 
The incidence of PU is still very high despite established risk factors and the attentiveness of 
healthcare professionals. In the range of 22.5% to 66.6% of patients, PU develops at some point during 
prolonged hospitalization. Each patient's ulcer costs around 1.71-470.49 Euros per day to treat, 
depending on the context. Although there are many different dressings and topical medications 
available, none has been proven to be better than the others [19-21]. 
To our knowledge, no study exists in the literature comparing the effects of local application of 
mebo and oxide zinc ointment in treatment of stage II pressure ulcer. Therefore, the present study was 
designed to compare the effects of zinc oxide versus MEBO in treatment of second stage pressure ulcer. 
 
Significance of the study 
Pressure Ulcers are associated with decreased quality of life and increased morbidity, mortality, and 
cost. A systematic review found that the cost of PU treatment varied from 1.7 to 470.5 € per patient per 
day across different settings. Additionally, PUs may cause emotional distress to patients and their 
families and frequently lead to their dissatisfaction with the health-care system and mistrust of the 
health-care providers [22]. 
Pressure ulcer risk assessment, prevention and management are important to reduce PU burden in 
ICU patients. Comprehensive evidence-based guidelines on PU prevention and care were recently 
updated. However, clinical studies about this topic are uncommon and mostly of low-to-moderate 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
quality. They emphasize the need for a multifaceted care approach and multidisciplinary involvement 
[23.24]. 
Globally, the incidence of pressure ulcers varied from 2 - 20 ulcer/1000 patient-days, depending on 
the institution and the population of patients studied. Also, the prevalence varied from 5-13% [25-27]. 
Nationally a study done by Al-Hashemi (2019) at King Abdulaziz Medical City (KAMC) – Jeddah-
Saudi Arabia revealed that the calculated incidence 1.6 ulcer/1000 patient-days and prevalence 5.7% in 
this study is very close to the figures published in the literature previously [28]. 
 
A network meta-analysis (2017) about dressings and topical agents for treating pressure ulcers 
(Review) of data from 39 studies (evaluating 21 dressings and topical agents for pressure ulcers) 
concluded that consequently we are unable to determine which dressings or topical agents are the most 
likely to heal pressure ulcers and more research is needed to determine whether particular dressings or 
topical agents improve the probability of healing of pressure ulcers [29]. Moreover Boyko et al. (2018), 
in a review of the current management of pressure ulcers, stated that despite many treatments available, 
none of them is superior to the other, and pressure ulcers remain a debilitating and costly issue. They 
recommended additional research to develop products more effective in preventing and treating pressure 
ulcers [20]. 
The incidence of pressure ulcers will possibly grow rapidly in the future due to increased life 
expectancy and aging. However, although various methods are used to treat pressure ulcers, no standard 
therapy has previously been established. After searching the literature there no studies done before to 
compare the effects of zinc oxide versus MEBO in treatment of second stage pressure ulcer and because 
there is no standardization for this practice this clinical trial will be conducted to compare the effects of 
zinc oxide versus MEBO in treatment of second stage pressure ulcer and determine which one is superior 
to other. 
 
OBJECTIVES:  
The primary objective of this study is to: 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 5 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
 - To evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of 
second stage pressure ulcer. 
Secondary Objectives 
- To determine the recovery time for both ointments. 
 
 Objective measures 
For the primary objective  
Wound healing will be assessed by using Bates–Jensen Wound Assessment Tool (BWAT) daily for both 
treatments. 
For the secondary objective  
The duration of treatment will be record at the assessment sheet so Recovery time will be determined 
from this sheet. 
Research Design:    
 Open label randomized control clinical trial study with a pilot study-using questionnaire.  
Inclusion Criteria:  
 Subjects ≥ 18  
 Willing to participate. 
 KAMC cases in medical ward, neuroscience ward, and intensive care unit. 
 Newly cases diagnosed with second stage pressure ulcer according to the European pressure 
ulcer advisory panel/national pressure ulcer advisory panel (NPUAP) guidelines.  
Exclusion Criteria:  

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 6 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
 Subjects under 18  
 Not consenting to participate  
 Patients with suspected hypersensitivity reactions to any of the topical formulation’s ingredients. 
 Either a category III or IV pressure ulcer. 
 Evidence of deep tissue injury (exudative drainage, purple or maroon localized area of discolored 
intact skin or blood-filled blister due to pressure damage). 
 Signs of wound infection (pus draining from the ulcer, a foul-smelling odour, tenderness, heat 
and increased redness in the surrounding skin and fever).  
 Patients who undertaking other therapies that could affect healing, such as corticosteroids, 
radiation therapy, or chemotherapy for cancer. 
 Heavy smoking (more than 20 cigarettes a day). 
 Concomitant chronic disease (e.g., diabetes mellitus or frank vascular disease such as Buerger's 
disease). 
  Patients who unable to continue the study because of death, discharge, or change in the care 
setting. 
 
Randomization 
Simple randomization method will be used through electronic randomization. The randomization list 
was generated electronically through R using the Random Allocation Rule by research center member 
who did not directly participate in trial recruitment and enrolment. Research center member will define 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 7 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
the participant for this concealment. Allocation sequence will be generated, and the oblique envelops 
will be created with the sequence in it and each envelop only open after patient consented and enrolled 
in the study to determine which treatment the participant will receive. 
Blinding 
Open label study as True blinding for patients and the research nurse who will apply the topical 
agent will be difficult as there is a significant difference among the two treatment methods in 
presentation, colour, density, and odour.  the author who will enroll the patients to the study will be blind 
to treatment assignment. To maintain the blinded status on assessment of outcomes, outcome assessors 
will be also blinded to treatment allocation.  
Study Procedure: 
After getting official permission from KAMC IRB, the subject will be randomized using 
electronic randomization 1:1 ratio. The randomization list was generated electronically through R using 
the Random Allocation Rule. The data will be collected using Assessment sheet of patient with second 
stage pressure ulcer tool. Patients will equally be allocated into 2 groups randomly. The zinc oxide group 
will receive topical zinc oxide twice every 12 hours daily and patients in the MEBO group will receive 
topical MEBO ointment twice every 12 daily.  
The research nurse will be instructed on how to apply the ointment on different surface areas 
(into and around the edge of ulcers) according to the fingertip unit (FTU). One FTU contains 
approximately 0.5 g of the ointment. Amounts that were applied to different parts were 7 FTUs for back, 
3 FTUs for 1 arm, 1 FTU for both sides of 1 hand, 6 FTUs for 1 leg, and 2 FTUs for 1 foot. The number 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 8 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
of FTUs applied will be altered by the size of the ulcer. For example, if the patient has a large ulcer on 
the heel, more ointment was applied in comparison to a small ulcer on a patient’s back. For infection 
prevention, povidone iodine will be used to clean pressure ulcers before MEBO or zinc oxide 
intervention. Then, the pressure ulcers will be cleansed with normal saline gauze. MEBO will be 
smeared successively onto the wounds at a thickness of 1mm twice daily with a sterile gloved finger. 
The same application will be used as for zinc oxide ointment. 
Furthermore, removal of the possible causal factors (pressure, shear, and friction) and control of 
the related general condition (such as nutrition, cleaning of the wound, and management of comorbid 
disease and other medical factors such as blood sugar level that might interfere with the healing process) 
will be considered for all patients as standard of care.  
To eliminate the possible complicating factor of treatment interactions, all patients in both groups 
will receive position change every 2 hours, and mattress that helps to protect the vulnerable skin. If a 
patient has more than one ulcer, all the ulcers will be treated by the same method of cleansing, applying 
and changing positions and the same treatment.  
Patient will be examined daily till complete healing for the pressure ulcer and maximum one 
month as it was reported by Li et al. (2017) reported that the use of MEBO for one week did not 
significantly affect the improvement of pressure ulcer grades [29]. Moreover, a study done by Palese 
2015 reported that to achieve complete re-epithelialization in Stage II PUs, it takes approximately 23 
days. This is quite a long time if we consider that pressures of only 60 to 70 mm Hg for between 30 and 
240 minutes are needed to cause tissue damage. On average, a small ulcer heals 12 days faster compared 
with those with a surface of 3.1 cm2 or greater [30] so patient will follow for maximum one month. If 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 9 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
the pressure ulcer not healed within the month of the treatment duration this patient will return to routine 
care of the hospital. If the any patient will be unable to continue the study because of death, discharge, 
or change in the care setting the researcher will be excluded from the study. 
 
Pilot study: 
It will conduct before data collection on 10% of patients to explore feasibility for future RCT, the 
efficiency, internal validity and fundamentally, the delivery of proposed trial and identify barriers and 
facilitators. Zinc oxide will be applied to 4 patients twice daily and MEBO will be applied to 4 patients 
twice daily till complete healing for the pressure ulcer and maximum one month. The study’ tool will 
be tested, and these patients will be excluded from the study, after completion the patient will have 
routine care for pressure ulcer treatment. 
Sample Size calculation:  
The sample size for the study calculated using the following formula based on the study of Li et al 
(2017). 
 
n = Sample size for one group that we need to find out  
p1 and p2 = Proportion of two groups  
C = Standard value for the corresponding level of α and β selected for the study (0.84+1.96)2. 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 10 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
n= 0.5 (1-0.5) + 0.167 (1-0.167) (0.84+1.96)2 / (0.5-0.167)2 = 27.5 ≈ 28 patients, in addition to attrition 
rate 20 % therefore sample size will be 34 patients for each group.  
 
A total number 76 patients will be included in the study. A number of eight participants will be included 
in the pilot study which will equal 10% of the total study number and will be excluded from the study.  
 
Duration of the Study: 12 months in total. The enrolment will be for six months. Follow up will be for 
maximum 1 months for each subject. A period of 6 months will be for analysis and closing. 
Setting:  
This study will be carried out at medical ward, neuroscience ward, and intensive care unit at King 
Abdullah Medical City, Holy Makkah. 
 
Data Collection and Management:   
After the official approval from KAMC IRB and the local authority approval. The principal 
investigator will have a meeting with the team for study implementation overview to ensure the quality 
and compliance. Researcher will explain the study to the participants and take written consent if they 
want to participate. For unconscious patient written approval will be taken from there Legally 
Acceptable Representative. The participation will be voluntary and anonymously. In case of passing 
away the collected data will not be used and safety reports will be submitted as per the local gaudiness. 
In case of discharge the collected data will not be used and the patient will be excluded. All data 
collection sheets will be kept in a locked file cabinet with the researchers.  

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 11 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
 
Study outcome measurement: 
Data will be collected through one tool that will be collected by the assessor daily. It will include two 
sections as follows:  
Section I: Patients’ demographic data 
This section was developed by the PI based on relevant literature. It will include demographic and 
medical history data will be collected from the patients’ medical records without identifier such as age, 
sex, body mass index, history of smoking, diagnosis at the time of admission, and laboratory parameters 
including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) will be recorded. 
Nutritional status of patients will be evaluated considering route of nutritional support (enteral or 
parenteral). Subject will be identify via serial codes. 
Section II:  Pressure ulcer assessment.  
This section will be adopted from Bates-Jensen 2010 [31]. The Bates–Jensen Wound Assessment 
Tool (BWAT) will be used to evaluate wound healing. It is a validated wound assessment tool which is 
used in many healthcare settings for wound assessment. BWAT is straight forward to use and allows 
nurses to have an objective, comprehensive assessment of wounds. It consists of 13 items to evaluate 
wound size, type and depth, amount of necrotic tissue, amount and characteristics of exudate, the 
presence of granulation tissue, epithelialization, and peri- 6 wound skin. PU length and width was 
measured with a disposable ruler and expressed as cm2. Patient will be examined daily till complete 
healing for the pressure ulcer and maximum one month. If the pressure ulcer not healed within the month 
of the treatment duration this patient will return to routine care of the hospital. If the any patient will be 
unable to continue the study because of death, discharge, or change in the care setting the researcher 
will be excluded from the study. 
Each item is graded on a scale of 1 to 5, where a score of 1 indicates progress toward healing while 
a score of 5 indicates the absence of healing or wound deterioration. Cumulative BWAT scores vary 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 12 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
from 13 to 65. The English version of BWAT has been reported to have good reliability (Cronbach 
alpha=0.91 and an interrater reliability coefficient of 0.99).  
The ulcer status will be completed by the assessor when the pressure ulcer healed or the end of the 
month, the ulcers will be examined blindly and assessed as “Completely Healed,” “Partially Healed,” 
“Without Improvement,” or “Worsening.”. “Completely healed” was defined as an intact dermis and 
epidermis, and no abrasion or ulceration. “Partially healed” was defined as any decrease in ulcer size 
compared with the baseline ulcer tracing but excluding complete healing. “Without improvement” was 
defined as no change in ulcer size compared with the baseline ulcer tracing. “Worsening” was defined 
as any increase in ulcer size compared with the baseline ulcer tracing. Duration of treatment will be 
record at the assessment sheet. 
 
Statistical Analysis Plan 
Data obtained from the study will be coded and transformed into coding sheets. The results will be 
checked. Then, the data will be entered into SPSS system files (SPSS package version 22). Following 
data entry, checking and verification process will be carried out to avoid any errors during data entry. 
Finally, analysis and interpretation of data will be conducted. Categorical variables will be expressed as 
number and percentage while continuous variables will be expressed as mean and standard deviation.  
Publication: 
The results of this research will be published to either national or international publications. The 
main credit in publication will go to King Abdullah Medical City in Holy Capital and to the principal 
investigator and co-investigators. Others who have contributed less substantially will have an 
acknowledgement in the manuscript.    
Ethical Part & Confidentiality: 

Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
- 13 - 
 
Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
 Ethical approval will be sought from KAMC IRB, local authority as applicable and will do study 
accordingly. Researcher will explain the study to the participants and take written consent if they want 
to participate. The participation will be voluntary and anonymously.  
 
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Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
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Impact of using zinc oxide versus Moist Exposed Wound Ointment (MEBO) in treatment 
of second stage pressure ulcer: A randomized control clinical trial. 
 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
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Short Title: Impact of using Zinc Oxide versus Moist Exposed Wound Ointment (MEBO) in treatment of  
                     second stage pressure ulcer: A randomized control clinical trial. 
Version: 5.0 (Dated 28-Mar-2023) 
Effective date: 29-Mar-2023 
Expiration date: 29-Mar-2024 
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