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| ID | Type | Description | Link |
|---|---|---|---|
| 23071104 | Other Identifier | Saudi Food and Drug Authority (SFDA) |
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randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The zinc oxide group | Active Comparator | The zinc oxide group will receive topical zinc oxide twice every 12 hours daily |
|
| MEBO group | Active Comparator | patients in the MEBO group will receive topical MEBO ointment twice every 12 daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEBO Wound Ointment | Drug | both are used for second pressure ulcer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | The duration of treatment will be record at the assessment sheet so Recovery time will be determined from this sheet. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wedian Almowallad, Master | Contact | +96612 5549999 | 18004 | Almwlld.W@kamc.med.sa |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Ebtisam AbdElatif Ebrahim, Master degree of science in nu | King Abdullah Medical City in Holy Capital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulla Medical City in Holy capital | Recruiting | Mecca | Western Reagan | 24211 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27384210 | Background | 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. | |
| 29392094 | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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we are still conducting the study after publication we might be interested and ready for sharing the full plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2023 | Jun 29, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2023 | Sep 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015034 | Zinc Oxide |
| ID | Term |
|---|---|
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
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A randomized control clinical trial
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no masking in this study
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| zinc oxide |
| Drug |
both are used to treat second degree pressure ulcer but with no superiority |
|
| King Abdulla Medical City in Holy capital | Completed | Mecca | Western Reagan | 24211 | Saudi Arabia |
| 26231383 | 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. |
| 25732278 | 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. |
| 28639707 | 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. |
| 19934462 | 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. |
| 17987872 | 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. |
| 20946425 | 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. |
| 28723796 | 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. |
| 20386331 | 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. |
| 6104076 | 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. |
| 470359 | 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. |
| 17521821 | 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. |
| 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 |
| 21991159 | 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. |
| 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) |
| 19073386 | 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. |
| 23917394 | 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. |
| 25550296 | 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. |
| 24393344 | 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. |
| 25991879 | 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. |
| 29463211 | 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. |
| 28833356 | 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. |
| 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 |
| 29223413 | 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. |
| 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. |
| 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 | View source |
| 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 | View source |
| Related Info | View source |