Pressure InjuryPhase 4NCT07193849
Zinc Oxide VS MEBO
A Phase 4 study testing MEBO Wound Ointment and zinc oxide in people with Pressure Injury and Pressure Injury Stage 2, run by King Abdullah Medical City at 2 sites in Saudi Arabia.
Trial summary
randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Pressure Injury Stage 2, Bedsore
- What is being tested?
- MEBO Wound Ointment and zinc oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 31 Dec 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 1 recruiting
- Recruiting
King Abdulla Medical City in Holy capital
Mecca, Western Reagan, 24211
wedian Almowallad, Master, +96612 5549999 ext. Ext: 18004, Almwlld.W@kamc.med.sa
Ebtisam AbdElatif Ebrahim, Master degree of science in nu
- Completed
King Abdulla Medical City in Holy capital
Mecca, Western Reagan, 24211
About this study
Official title: Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial
randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.
Read the detailed description
In this study 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. Patient will be examined daily till complete healing for the pressure ulcer and maximum one month. 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
- Conditions
- Pressure Injury, Pressure Injury Stage 2, Bedsore, Pressure Ulcers Stage II, Pressure Ulcer, Buttock
- Being tested
- MEBO Wound Ointment, zinc oxide
- Keywords
- pressure injury, pressure ulcer, MEBO, Zinc oixid
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEBO Wound OintmentDrug
both are used for second pressure ulcer
zinc oxideDrug
both are used to treat second degree pressure ulcer but with no superiority
| Study group | Role | What they receive |
|---|---|---|
| The zinc oxide group | Active comparator | The zinc oxide group will receive topical zinc oxide twice every 12 hours daily Receives: Drug: zinc oxide |
| MEBO group | Active comparator | patients in the MEBO group will receive topical MEBO ointment twice every 12 daily Receives: Drug: MEBO Wound Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing will be assessed by using Bates-Jensen Wound Assessment Tool (BWAT) daily for both treatments.
(BWAT) consists of 13 items to evaluate wound size, type and depth, 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 from 13 to 65
Measured: 30 days
Secondary outcomes (1)
Recovery time
The duration of treatment will be record at the assessment sheet so Recovery time will be determined from this sheet.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start31 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control clinical trial
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah Medical City
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu, Principal investigator, King Abdullah Medical City in Holy Capital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193849
- Sponsor's protocol ID
- 23-1032
- Other IDs
- 23071104
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we are still conducting the study after publication we might be interested and ready for sharing the full plan
Publications
Andrade CC, Almeida CF, Pereira WE, Alemao MM, Brandao CM, Borges EL. Costs of topical treatment of pressure ulcer patients. Rev Esc Enferm USP. 2016 Apr;50(2):295-301. doi: 10.1590/S0080-623420160000200016. English, Portuguese.
PubMed 27384210Boyko TV, Longaker MT, Yang GP. Review of the Current Management of Pressure Ulcers. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):57-67. doi: 10.1089/wound.2016.0697.
PubMed 29392094Demarre L, Van Lancker A, Van Hecke A, Verhaeghe S, Grypdonck M, Lemey J, Annemans L, Beeckman D. The cost of prevention and treatment of pressure ulcers: A systematic review. Int J Nurs Stud. 2015 Nov;52(11):1754-74. doi: 10.1016/j.ijnurstu.2015.06.006. Epub 2015 Jun 25.
PubMed 26231383Qaseem A, Mir TP, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Risk assessment and prevention of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2015 Mar 3;162(5):359-69. doi: 10.7326/M14-1567.
PubMed 25732278Westby MJ, Dumville JC, Soares MO, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD011947. doi: 10.1002/14651858.CD011947.pub2.
PubMed 28639707VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009 Nov 1;55(11):39-45.
PubMed 19934462Gibbons W, Shanks HT, Kleinhelter P, Jones P. Eliminating facility-acquired pressure ulcers at Ascension Health. Jt Comm J Qual Patient Saf. 2006 Sep;32(9):488-96. doi: 10.1016/s1553-7250(06)32064-8.
PubMed 17987872Zaratkiewicz S, Whitney JD, Lowe JR, Taylor S, O'Donnell F, Minton-Foltz P. Development and implementation of a hospital-acquired pressure ulcer incidence tracking system and algorithm. J Healthc Qual. 2010 Nov-Dec;32(6):44-51. doi: 10.1111/j.1945-1474.2010.00076.x.
PubMed 20946425Li W, Ma Y, Yang Q, Pan Y, Meng Q. Moist exposed burn ointment for treating pressure ulcers: A multicenter randomized controlled trial. Medicine (Baltimore). 2017 Jul;96(29):e7582. doi: 10.1097/MD.0000000000007582.
PubMed 28723796Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab.
PubMed 20386331Golden MH, Golden BE, Jackson AA. Skin breakdown in kwashiorkor responds to zinc. Lancet. 1980 Jun 7;1(8180):1256. doi: 10.1016/s0140-6736(80)91722-5. No abstract available.
PubMed 6104076Haley JV. Zinc sulfate and wound healing. J Surg Res. 1979 Sep;27(3):168-74. doi: 10.1016/0022-4804(79)90127-6. No abstract available.
PubMed 470359Jurjus A, Atiyeh BS, Abdallah IM, Jurjus RA, Hayek SN, Jaoude MA, Gerges A, Tohme RA. Pharmacological modulation of wound healing in experimental burns. Burns. 2007 Nov;33(7):892-907. doi: 10.1016/j.burns.2006.10.406. Epub 2007 May 22.
PubMed 17521821Wang QS, Tang QL, Zhang L, et al. MEBO for treating 47 cases of chronic ischemic ulcer in lower limber. Chin J Burns Wound Surface Ulcer 2005; 17:296-7. (In Chinese)
National Pressure Ulcer Advisory Panel (NPUAP). PUSH Tool. Washington, DC: National Pressure Ulcer Advisory Panel; 2010
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT07193849
- Acronym / sponsor ID
- 23-1032
- Conditions
- Pressure Injury, Pressure Injury Stage 2, Bedsore, Pressure Ulcers Stage II, Pressure Ulcer, Buttock
- Keywords
- pressure injury, pressure ulcer, MEBO, Zinc oixid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- King Abdullah Medical CityOther government
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.
Detailed description
In this study 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. Patient will be examined daily till complete healing for the pressure ulcer and maximum one month. 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| The zinc oxide group | Active comparator | Drug: zinc oxideThe zinc oxide group will receive topical zinc oxide twice every 12 hours daily |
| MEBO group | Active comparator | Drug: MEBO Wound Ointmentpatients in the MEBO group will receive topical MEBO ointment twice every 12 daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEBO Wound Ointmentboth are used for second pressure ulcer | Drug | MEBO group |
| zinc oxideboth are used to treat second degree pressure ulcer but with no superiority | Drug | The zinc oxide group |
Primary outcome
Wound healing
Time frame: 30 days
Wound healing will be assessed by using Bates-Jensen Wound Assessment Tool (BWAT) daily for both treatments. (BWAT) consists of 13 items to evaluate wound size, type and depth, 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 from 13 to 65
1 secondary outcome
Recovery time
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 27384210Andrade CC, Almeida CF, Pereira WE, Alemao MM, Brandao CM, Borges EL. Costs of topical treatment of pressure ulcer patients. Rev Esc Enferm USP. 2016 Apr;50(2):295-301. doi: 10.1590/S0080-623420160000200016. English, Portuguese.
- Background: PubMed 29392094Boyko TV, Longaker MT, Yang GP. Review of the Current Management of Pressure Ulcers. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):57-67. doi: 10.1089/wound.2016.0697.
- Background: PubMed 26231383Demarre L, Van Lancker A, Van Hecke A, Verhaeghe S, Grypdonck M, Lemey J, Annemans L, Beeckman D. The cost of prevention and treatment of pressure ulcers: A systematic review. Int J Nurs Stud. 2015 Nov;52(11):1754-74. doi: 10.1016/j.ijnurstu.2015.06.006. Epub 2015 Jun 25.
- Background: PubMed 25732278Qaseem A, Mir TP, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Risk assessment and prevention of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2015 Mar 3;162(5):359-69. doi: 10.7326/M14-1567.
- Background: PubMed 28639707Westby MJ, Dumville JC, Soares MO, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD011947. doi: 10.1002/14651858.CD011947.pub2.
- Background: PubMed 19934462VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009 Nov 1;55(11):39-45.
- Background: PubMed 17987872Gibbons W, Shanks HT, Kleinhelter P, Jones P. Eliminating facility-acquired pressure ulcers at Ascension Health. Jt Comm J Qual Patient Saf. 2006 Sep;32(9):488-96. doi: 10.1016/s1553-7250(06)32064-8.
- Background: PubMed 20946425Zaratkiewicz S, Whitney JD, Lowe JR, Taylor S, O'Donnell F, Minton-Foltz P. Development and implementation of a hospital-acquired pressure ulcer incidence tracking system and algorithm. J Healthc Qual. 2010 Nov-Dec;32(6):44-51. doi: 10.1111/j.1945-1474.2010.00076.x.
- Background: PubMed 28723796Li W, Ma Y, Yang Q, Pan Y, Meng Q. Moist exposed burn ointment for treating pressure ulcers: A multicenter randomized controlled trial. Medicine (Baltimore). 2017 Jul;96(29):e7582. doi: 10.1097/MD.0000000000007582.
- Background: PubMed 20386331Harris C, Bates-Jensen B, Parslow N, Raizman R, Singh M, Ketchen R. Bates-Jensen wound assessment tool: pictorial guide validation project. J Wound Ostomy Continence Nurs. 2010 May-Jun;37(3):253-9. doi: 10.1097/WON.0b013e3181d73aab.
- Background: PubMed 6104076Golden MH, Golden BE, Jackson AA. Skin breakdown in kwashiorkor responds to zinc. Lancet. 1980 Jun 7;1(8180):1256. doi: 10.1016/s0140-6736(80)91722-5. No abstract available.
- Background: PubMed 470359Haley JV. Zinc sulfate and wound healing. J Surg Res. 1979 Sep;27(3):168-74. doi: 10.1016/0022-4804(79)90127-6. No abstract available.
- Palese, Alvisa, et al. "What is the healing time of stage II pressure ulcers? findings from a secondary analysis." Advances in skin \& wound care 28.2 (2015): 69-75.Link provided by the sponsor.
- Al-Hashemi, H., Alqurashi, K., Jan, R., Farran, A., Al-Sabban, B., \& Thomson, J. (2019). Incidence, prevalence, and complications of pressure ulcers in general medical and surgical units using a multidisciplinary model (Prospective cohort). Biomedical JoLink provided by the sponsor.
- Haesler E, editor. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Osborne Park, Australia: Cambridge Media; 2014Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. we are still conducting the study after publication we might be interested and ready for sharing the full plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu principal investigator
King Abdullah Medical City in Holy Capital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MEBO Wound Ointment and zinc oxide in people with Pressure Injury and Pressure Injury Stage 2, run by King Abdullah Medical City at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wedian Almowallad, Master (+96612 5549999 ext. 18004, Almwlld.W@kamc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07193849, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.