Surgery
Conditions
Brief summary
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.
Detailed description
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day. The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.
Interventions
DRUG2% CHG Cloth solution
Investigational CHG
DEVICEVehicle Cloth
Excipients from CHG cloth only
DRUGActive Comparator
Active comparator
OTHERSaline
Negative control
OTHERSLS
Provides a slight irritation for a positive control
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Free of skin disorders * Signed consent
Exclusion criteria
* Allergies to latex * Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing * severe illness * Pregnant (females)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grading Scale for Visual Evaluation of Skin Condition | 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249) | Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading |
Countries
United States
Participant flow
Recruitment details
39 of the 249 participants participated in both the Irritation and Sensitization Studies.
Pre-assignment details
Participants received up to 5 products simultaneously on their skin. SLS was only used in the Irritation study (39 subjects) as a positive control.
Participants by arm
| Arm | Count |
|---|---|
| 2% CHG, Vehicle, DynaHex, Saline Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study) | 249 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Irritation | Adverse Event | 6 |
| Sensitization | Adverse Event | 55 |
Baseline characteristics
| Characteristic | 2% CHG, Vehicle, DynaHex, Saline |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 226 Participants |
| Age, Continuous | 38 years |
| Region of Enrollment United States | 249 participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 249 | 0 / 249 | 15 / 249 | 0 / 249 | 1 / 39 |
| serious Total, serious adverse events | 0 / 249 | 0 / 249 | 0 / 249 | 0 / 249 | 0 / 39 |
Outcome results
Primary
Grading Scale for Visual Evaluation of Skin Condition
Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
Time frame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Population: Participants received more than one product at a time.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 2% CHG Cloth | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| 2% CHG Cloth | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Day 21 | 2.9 Scores Ranging (0-7) |
| 2% CHG Cloth | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| 2% CHG Cloth | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Day 35 | 0.12 Scores Ranging (0-7) |
| Vehicle Cloth | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| Vehicle Cloth | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Day 35 | 0.03 Scores Ranging (0-7) |
| Vehicle Cloth | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Day 21 | 1.4 Scores Ranging (0-7) |
| Vehicle Cloth | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| DynaHex (2% CHG) | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Day 35 | 0.03 Scores Ranging (0-7) |
| DynaHex (2% CHG) | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Day 21 | 3.3 Scores Ranging (0-7) |
| DynaHex (2% CHG) | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| DynaHex (2% CHG) | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| Saline | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| Saline | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Day 21 | 0.7 Scores Ranging (0-7) |
| Saline | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Day 35 | 0 Scores Ranging (0-7) |
| Saline | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| Sodium Lauryl Sulfate (SLS) | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Day 35 | 0 Scores Ranging (0-7) |
| Sodium Lauryl Sulfate (SLS) | Grading Scale for Visual Evaluation of Skin Condition | Sensitization Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |
| Sodium Lauryl Sulfate (SLS) | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Day 21 | 3.0 Scores Ranging (0-7) |
| Sodium Lauryl Sulfate (SLS) | Grading Scale for Visual Evaluation of Skin Condition | Irritation Mean Visualization Score Baseline | 0 Scores Ranging (0-7) |