This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications
The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Brijjit® is a non-invasive device which serves as a force modulating tissues bridges (FMTB) to aid in wound healing. This device used in would closure and serves to modify the mechanical forces on a wound which are implicated in adverse outcomes including scar formation and complications like wound dehiscence. Brijjit® is a flexible device which attaches via adhesive to the tissue on either side of the wound, approximates the tissue and off-loads forces.
NYU Langone Health
New York, New York, United States
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: screening/baseline visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 2 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 4 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
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Time frame: week 6 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 8 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 3-month post-surgery visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 6-months post-surgery visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 12-months post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: screening/baseline visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 2 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 4 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 6 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: week 8 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 3-month post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 6-months post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Time frame: 12-months post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: screening/baseline visir
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: week 2 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: week 4 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: week 6 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: week 8 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: 3-month post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: 6-months post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Time frame: 12-months post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: screening/baseline visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: week 2 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: week 4 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: week 6 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: week 8 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: 3-month post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: 6-months post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Time frame: 12-months post-surgery visit