Pressure Injury, Pressure Injury Stage 2, Bedsore, Pressure Ulcers Stage II, Pressure Ulcer, Buttock
Conditions
Keywords
pressure injury, pressure ulcer, MEBO, Zinc oixid
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.
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
Interventions
both are used for second pressure ulcer
DRUGzinc oxide
both are used to treat second degree pressure ulcer but with no superiority
Sponsors
King Abdullah Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking in this study
Intervention model description
A randomized control clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | 30 days | The duration of treatment will be record at the assessment sheet so Recovery time will be determined from this sheet. |
Countries
Saudi Arabia
Contacts
Primary Contactwedian Almowallad, Master
Outcome results
None listed