Zinc oxide vs MEBO for stage 2 pressure ulcers
Impact of Using Zinc Oxide Versus Moist Exposed Wound Ointment (MEBO) in Treatment of Second Stage Pressure Ulcer: A Randomized Control Clinical Trial
This trial tests whether applying zinc oxide or MEBO ointment heals stage 2 pressure ulcers faster in hospitalized patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Abdullah Medical City Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Mecca, Western Reagan and 1 other locations) |
| Trial ID | NCT07193849 on ClinicalTrials.gov |
What this trial studies
Adults with newly diagnosed stage 2 pressure ulcers at King Abdullah Medical City are randomized 1:1 to receive either topical zinc oxide or MEBO ointment. Treatments are applied twice every 12 hours and patients are examined daily until complete healing or for up to one month. Wound healing is measured using the Bates-Jensen Wound Assessment Tool and data are recorded on a standardized assessment sheet. Randomization is performed electronically in R using the Random Allocation Rule.
Who should consider this trial
Good fit: Hospitalized patients at King Abdullah Medical City with newly diagnosed stage 2 pressure ulcers who consent and are not receiving therapies that interfere with wound healing are eligible.
Not a fit: Patients with stage III/IV ulcers, deep tissue injury, signs of wound infection, hypersensitivity to the ointments, active cancer therapies, or heavy smoking are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, one ointment could speed healing of stage 2 pressure ulcers and reduce complications and length of stay.
How similar studies have performed: Topical zinc formulations and moist-exposed ointments have shown wound-healing benefits in other settings, but direct head-to-head comparisons for stage 2 pressure ulcers are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: * 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.
Where this trial is running
Mecca, Western Reagan and 1 other locations
- King Abdulla Medical City in Holy capital — Mecca, Western Reagan, Saudi Arabia (Recruiting)
- King Abdulla Medical City in Holy capital — Mecca, Western Reagan, Saudi Arabia (Completed)
Study contacts
- Principal investigator: Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu — King Abdullah Medical City in Holy Capital
- Study coordinator: wedian Almowallad, Master
- Email: Almwlld.W@kamc.med.sa
- Phone: +96612 5549999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.