Zinc Oxide VS MEBO

King Abdullah Medical City

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: MEBO Wound Ointment; Drug: zinc oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT07193849

23-1032

23071104 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

The zinc oxide group

Active Comparator group

Description:

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

Treatment:

Drug: zinc oxide

MEBO group

Active Comparator group

Description:

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

Treatment:

Drug: MEBO Wound Ointment