An interventional study of CO2 Laser Administration in Skin Scarring, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to female participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
Browse Cicatrix studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a group which will receive laser therapy to one breast incision at the first post-operative visit
Other: CO2 Laser Administration
a group which will receive laser therapy to one breast incision 6 weeks after surgery
Other: CO2 Laser Administration
The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).
Change in Vancouver Scar Scale Score
Total of score of each measure below: * Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 * Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 * Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 * Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3
Time frame: 1 Week to Post Laser 1-Year
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Aug 2019, 21 months after the start.
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This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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