Pressure Ulcers
Conditions
Keywords
skin ulcers
Brief summary
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
Detailed description
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.
Interventions
DEVICETheraHoney HD
Honey
DEVICESkinTegrity
Hydrogel
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female subjects of any age * Sacral wounds with necrotic tissue
Exclusion criteria
* 3rd degree burns * know hypersensitivity to products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wounds Healed | 3 weeks | Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 3 weeks | Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TheraHoney HD Honey product
TheraHoney HD: Honey | 11 |
| SkinTegrity Skin moisturizer
SkinTegrity: Hydrogel | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | Total | TheraHoney HD | SkinTegrity |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 9 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 11 | 1 / 10 |
| serious Total, serious adverse events | 1 / 11 | 2 / 10 |
Outcome results
Primary
Percentage of Wounds Healed
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TheraHoney HD | Percentage of Wounds Healed | 63.1 percentage of wounds | Standard Deviation 38.4 |
| SkinTegrity | Percentage of Wounds Healed | 6.1 percentage of wounds | Standard Deviation 74.7 |
Secondary
Number of Participants With Adverse Events
Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
Time frame: 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TheraHoney HD | Number of Participants With Adverse Events | 1 Participants |
| SkinTegrity | Number of Participants With Adverse Events | 2 Participants |