Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-02-12

Brief Summary

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This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADHESIVE BANDAGE #1

bandage applied to wounded site.

Group Type EXPERIMENTAL

ADHESIVE BANDAGE #1

Intervention Type DEVICE

Bandage applied daily to wounded site for 14 days

ADHESIVE BANDAGE #2

bandage applied to wounded site.

Group Type EXPERIMENTAL

ADHESIVE BANDAGE #2

Intervention Type DEVICE

Bandage applied daily to wounded site for 14 days

ADHESIVE BANDAGE #3

bandage applied to wounded site

Group Type EXPERIMENTAL

ADHESIVE BANDAGE #3

Intervention Type DEVICE

Bandage applied daily to wounded site for 14 days

Antibacterial Bandage with 0.8% BZK

bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site

Group Type EXPERIMENTAL

Antibacterial Bandage with 0.8% BZK

Intervention Type DEVICE

bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days

Intact and No Bandage

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Group Type OTHER

Intact and No Bandage

Intervention Type OTHER

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Wounded and No Bandage

This test site will be wounded and no bandage applied, serving as a positive control site.

Group Type OTHER

Wounded and No Bandage

Intervention Type OTHER

This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Interventions

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ADHESIVE BANDAGE #1

Bandage applied daily to wounded site for 14 days

Intervention Type DEVICE

ADHESIVE BANDAGE #2

Bandage applied daily to wounded site for 14 days

Intervention Type DEVICE

ADHESIVE BANDAGE #3

Bandage applied daily to wounded site for 14 days

Intervention Type DEVICE

Antibacterial Bandage with 0.8% BZK

bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days

Intervention Type DEVICE

Intact and No Bandage

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Intervention Type OTHER

Wounded and No Bandage

This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18 to 55 years of age.
2. Fitzpatrick skin types I to III.
3. Must be able to comprehend and follow the requirements of the study
4. Avoid excessive sun exposure
5. Willing to refrain from topical product use on the back for the duration of the study.
6. Subjects must agree not to immerse their bandages in water for the duration of the study.
7. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control

Exclusion Criteria

1. Excessively hairy back, acne, scars and pigmentation or nevi t
2. . Pregnant or Lactating, or planning on becoming pregnant;
3. . Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
4. . Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
5. Participation in any other clinical study within 30 days of Visit 1;
6. . Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
7. Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
8. Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
9. Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
10. . Subjects with a known history of keloid or hypertrophic scar formation;
11. Subjects diagnosed with any blood clotting disorder;
12. Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;

14\. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes