Zinc Oxide VS MEBO

NCT07193849 | Recruiting Phase 4

• 2 other identifiers: 23-103223071104
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.

Conditions

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

Keywords

pressure injury; pressure ulcer; MEBO; Zinc oixid

Outcome Measures

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

  30 days

Secondary Outcomes (1)

• Recovery time

  30 days

Study Arms (2)

The zinc oxide group

ACTIVE COMPARATOR

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

Drug: zinc oxide

MEBO group

ACTIVE COMPARATOR

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

Drug: MEBO Wound Ointment

Interventions

MEBO Wound Ointment DRUG

both are used for second pressure ulcer

MEBO group

zinc oxide DRUG

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

The zinc oxide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah Medical City: lead

Study Sites (2)

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, 24211, Saudi Arabia

RECRUITING

King Abdulla Medical City in Holy capital

Mecca, Western Reagan, 24211, Saudi Arabia

COMPLETED

Related Publications (28)

• 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.

  PMID: 27384210 BACKGROUND

• 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.

  PMID: 29392094 BACKGROUND

• 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.

  PMID: 26231383 BACKGROUND

• 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.

  PMID: 25732278 BACKGROUND

• 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.

  PMID: 28639707 BACKGROUND

• 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.

  PMID: 19934462 BACKGROUND

• 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.

  PMID: 17987872 BACKGROUND

• 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.

  PMID: 20946425 BACKGROUND

• 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.

  PMID: 28723796 BACKGROUND

• 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.

  PMID: 20386331 BACKGROUND

• 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.

  PMID: 6104076 BACKGROUND

• 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.

  PMID: 470359 BACKGROUND

• 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.

  PMID: 17521821 BACKGROUND

• 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)

  BACKGROUND

• National Pressure Ulcer Advisory Panel (NPUAP). PUSH Tool. Washington, DC: National Pressure Ulcer Advisory Panel; 2010

  BACKGROUND

• 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.

  PMID: 21991159 BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 19073386 BACKGROUND

• 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.

  PMID: 23917394 BACKGROUND

• 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.

  PMID: 25550296 BACKGROUND

• 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.

  PMID: 24393344 BACKGROUND

• 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.

  PMID: 25991879 BACKGROUND

• 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.

  PMID: 29463211 BACKGROUND

• 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.

  PMID: 28833356 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29223413 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• 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.
• 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 Jo
• 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; 2014
• Related Info

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Zinc Oxide

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu

  King Abdullah Medical City in Holy Capital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wedian Almowallad, Master

CONTACT

+96612 5549999; Almwlld.W@kamc.med.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized control clinical trial

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: September 26, 2025
• Study Start: December 31, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

SA (2)