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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Bandage applied daily to wounded site for 14 days
Bandage applied daily to wounded site for 14 days
Bandage applied daily to wounded site for 14 days
TKL Research Inc.
Fair Lawn, New Jersey, United States
Microbial Community Richness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
Time frame: Baseline (Day 0)
Microbial Community Richness - (Day 1)
Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 1
Microbial Community Richness - (Day 2)
Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 2
Microbial Community Richness - (Day 3)
Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 3
Microbial Community Richness - (Day 4)
Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 4
Microbial Community Richness - (Day 5)
Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 5
Microbial Community Richness - (Day 6)
Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
This test site will be wounded but will not be treated with a bandage, serving as the positive control site.
Time frame: Day 6
Microbial Community Richness - (Day 7)
Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.
Time frame: Day 7
Microbial Community Richness - (Day 14)
Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Time frame: Day 14
Microbial Community Diversity - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Time frame: Baseline (Day 0)
Microbial Community Diversity - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Time frame: Day 1
Microbial Community Diversity - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Time frame: Day 2
Microbial Community Diversity - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Time frame: Day 3
Microbial Community Diversity - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Time frame: Day 4
Microbial Community Diversity - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Time frame: Day 5
Microbial Community Diversity - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Time frame: Day 6
Microbial Community Diversity - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Time frame: Day 7
Microbial Community Diversity - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Time frame: Day 14
Microbial Community Evenness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Time frame: Day 0
Microbial Community Evenness - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Time frame: Day 1
Microbial Community Evenness - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Time frame: Day 2
Microbial Community Evenness - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Time frame: Day 3
Microbial Community Evenness - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Time frame: Day 4
Microbial Community Evenness - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Time frame: Day 5
Microbial Community Evenness - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Time frame: Day 6
Microbial Community Evenness - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Time frame: Day 7
Microbial Community Evenness - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
Time frame: Day 14
Skin Barrier Function -Baseline (Day 0)
The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).
Time frame: Day 0
Skin Barrier Function - Day 1
The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 1
Skin Barrier Function - Day 2
The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 2
Skin Barrier Function - Day 3
The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 3
Skin Barrier Function - Day 4
The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 4
Skin Barrier Function - Day 5
The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 5
Skin Barrier Function - Day 6
The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 6
Skin Barrier Function - Day 7
The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 7
Skin Barrier Function - Day 14
The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).
Time frame: Day 14
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 0
Redness: Wound Area Oxyhemoglobin Level - Day 1
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 1
Redness: Wound Area Oxyhemoglobin Level - Day 2
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 2
Redness: Wound Area Oxyhemoglobin Level - Day 3
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 3
Redness: Wound Area Oxyhemoglobin Level - Day 4
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 4
Redness: Wound Area Oxyhemoglobin Level - Day 5
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 5
Redness: Wound Area Oxyhemoglobin Level - Day 6
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 6
Redness: Wound Area Oxyhemoglobin Level - Day 7
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 7
Redness: Wound Area Oxyhemoglobin Level - Day 14
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Time frame: Day 14