Study Results
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Basic Information
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RECRUITING
PHASE4
76 participants
INTERVENTIONAL
2023-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The zinc oxide group
The zinc oxide group will receive topical zinc oxide twice every 12 hours daily
zinc oxide
both are used to treat second degree pressure ulcer but with no superiority
MEBO group
patients in the MEBO group will receive topical MEBO ointment twice every 12 daily
MEBO Wound Ointment
both are used for second pressure ulcer
Interventions
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MEBO Wound Ointment
both are used for second pressure ulcer
zinc oxide
both are used to treat second degree pressure ulcer but with no superiority
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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King Abdullah Medical City
OTHER_GOV
Responsible Party
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Principal Investigators
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Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu
Role: PRINCIPAL_INVESTIGATOR
King Abdullah Medical City in Holy Capital
Locations
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King Abdulla Medical City in Holy capital
Mecca, Western Reagan, Saudi Arabia
King Abdulla Medical City in Holy capital
Mecca, Western Reagan, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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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
Other Identifiers
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23071104
Identifier Type: OTHER
Identifier Source: secondary_id
23-1032
Identifier Type: -
Identifier Source: org_study_id
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