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RecruitingNCT07193849Updated Sep 26, 2025

Zinc Oxide VS MEBO

A Phase 4 interventional study of MEBO Wound Ointment and zinc oxide in Pressure Injury, Pressure Injury Stage 2 and Bedsore, sponsored by King Abdullah Medical City. Recruiting at 2 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by King Abdullah Medical City · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Dec 2023, registered Jun 2025).
  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Pressure Injury
  • Pressure Injury Stage 2
  • Bedsore
  • Pressure Ulcers Stage II
  • Pressure Ulcer, Buttock

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Keywords

  • pressure injury
  • pressure ulcer
  • MEBO
  • Zinc oixid
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 76 is close to the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

King Abdullah Medical City is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Active comparator
    The zinc oxide group

    The zinc oxide group will receive topical zinc oxide twice every 12 hours daily

    Drug: zinc oxide

  • Active comparator
    MEBO group

    patients in the MEBO group will receive topical MEBO ointment twice every 12 daily

    Drug: MEBO Wound Ointment

Interventions

  • DrugMEBO Wound Ointment

    both are used for second pressure ulcer

  • Drugzinc oxide

    both are used to treat second degree pressure ulcer but with no superiority

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 30 days

07

Study locations

1 of 2 sites recruiting
  • King Abdulla Medical City in Holy capital
    Mecca, Western Reagan 24211, Saudi Arabia
    • wedian Almowallad, Master · Contact · Almwlld.W@kamc.med.sa · +96612 5549999
    • Ebtisam AbdElatif Ebrahim, Master degree of science in nu · Principal investigator
    Recruiting
  • King Abdulla Medical City in Holy capital
    Mecca, Western Reagan 24211, Saudi Arabia
    Completed
08

References and documents

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 27384210 ↗
  • Boyko 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 29392094 ↗
  • Demarre 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 26231383 ↗
  • Qaseem 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 25732278 ↗
  • Westby 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 28639707 ↗
  • VanGilder 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 19934462 ↗
  • Gibbons 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 17987872 ↗
  • Zaratkiewicz 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 20946425 ↗
  • Li 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 28723796 ↗
  • Harris 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 20386331 ↗
  • Golden 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 6104076 ↗
  • Haley 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 470359 ↗
  • Jurjus 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 17521821 ↗
  • Wang 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
  • Jewo PI, Fadeyibi IO, Babalola OS, Saalu LC, Benebo AS, Izegbu MC, Ashiru OA. A Comparative Study of the Wound Healing Properties of Moist Exposed Burn Ointment (MEBO) and Silver Sulphadiazine. Ann Burns Fire Disasters. 2009 Jun 30;22(2):79-82. PubMed 21991159 ↗
  • Li JH, Zhang L, Tang QL, et al. Clinical observation on effect of MEBO on neurogenic ulcer. Liaoning J Tradit Chin Med 2012; 39:1095-6. (In Chinese)
  • Hirsch T, Ashkar W, Schumacher O, Steinstraesser L, Ingianni G, Cedidi CC. Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy. Eur J Med Res. 2008 Nov 24;13(11):505-10. PubMed 19073386 ↗
  • Yue J, Zhang Q, Sun Z, Du W, Yu C. A case of electroacupuncture therapy for pressure ulcer. Acupunct Med. 2013 Dec;31(4):450-1. doi: 10.1136/acupmed-2013-010418. Epub 2013 Aug 5. No abstract available. PubMed 23917394 ↗
  • Zhang QH, Yue JH, Li CR, Sun ZR. Moxibustion for the treatment of pressure ulcers: study protocol for a pilot, multicentre, randomised controlled trial. BMJ Open. 2014 Dec 30;4(12):e006423. doi: 10.1136/bmjopen-2014-006423. PubMed 25550296 ↗
  • Zhang QH, Yue JH, Sun ZR. Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial. Trials. 2014 Jan 6;15:7. doi: 10.1186/1745-6215-15-7. PubMed 24393344 ↗
  • Bhattacharya S, Mishra RK. Pressure ulcers: Current understanding and newer modalities of treatment. Indian J Plast Surg. 2015 Jan-Apr;48(1):4-16. doi: 10.4103/0970-0358.155260. PubMed 25991879 ↗
  • Yap TL, Kennerly SM, Horn SD, Bergstrom N, Datta S, Colon-Emeric C. TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors. BMC Geriatr. 2018 Feb 20;18(1):54. doi: 10.1186/s12877-018-0744-0. PubMed 29463211 ↗
  • Coleman S, Smith IL, McGinnis E, Keen J, Muir D, Wilson L, Stubbs N, Dealey C, Brown S, Nelson EA, Nixon J. Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T). J Adv Nurs. 2018 Feb;74(2):407-424. doi: 10.1111/jan.13444. Epub 2017 Sep 28. PubMed 28833356 ↗
  • Saghalein S, Dehghan K, Shadvar K, Mahmoodpoor A, Sanaie S, Ostadi Z. Bedsore: Epidemiology; Risk Factors; Classification; Assessment Scales and Management. Archives of Anesthesiology and Critical Care. 2016;2(3):226-30
  • de Almeida Medeiros AB, da Conceicao Dias Fernandes MI, de Sa Tinoco JD, Cossi MS, de Oliveira Lopes MV, de Carvalho Lira ALB. Predictors of pressure ulcer risk in adult intensive care patients: A retrospective case-control study. Intensive Crit Care Nurs. 2018 Apr;45:6-10. doi: 10.1016/j.iccn.2017.09.007. Epub 2017 Dec 7. PubMed 29223413 ↗
  • Asghar M, Naseem S. Risk factors of pressure ulcer in elderly non-operative femur fracture patients. International Journal of Recent Scientific Research. 2018;9(7):28088-90.
  • Kumar A, Sinha V. Comparative study of EUSOL and Silverstream in healing of pressure sore in traumatic spinal cord injury patients. International Journal of Orthopaedics. 2018;4(1):228-34.

Study documents

  • Study protocol · Mar 28, 2023
  • Informed consent form · Feb 21, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — we are still conducting the study after publication we might be interested and ready for sharing the full plan

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07193849
Lead sponsor
King Abdullah Medical City
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Dec 31, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 26, 2025

Study contacts

wedian Almowallad, Master
Contact
Almwlld.W@kamc.med.sa
+96612 5549999 ext. 18004
Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu
principal investigator · King Abdullah Medical City in Holy Capital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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