A Phase 2 interventional study of tissue bonding and sutures in Basal Cell Carcinoma, Squamous Cell Carcinoma and Atypical Nevus, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-10.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
The broad aim of this study is to evaluate the efficacy of photochemical tissue bonding (PTB) for the closure of skin excisions. We will test the hypothesis that full thickness skin excisions treated with PTB can heal with less scarring than those treated with the conventional suture closure method.
Hypertrophic scarring is a frequent endpoint after traditional surgical excision of skin cancers of the chest. These scars create significant long-term morbidity to the patient. There is a clinical need for an alternative treatment that would reduce factors associated with hypertrophic and possibly keloid scar formation by providing minimal tension, low infection risk and an absence of foreign body material. This would result in a normal appearing and healed scar without associated patient morbidity. Photochemical tissue bonding may provide this alternate treatment. PTB differs from sutures by continuously joining the tissue surfaces on a molecular level rather than only at discrete suture points. In addition, PTB does not incite foreign body reactions nor create tissue injury during passage of the needle and tying a knot, injuries that may initiate scarring.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
History of underlying photosensitivity condition Skin phototypes V-VI Use of photosensitizing medication History of Accutane use within the past 12 months History of underlying bleeding disorder or use of anticoagulant (e.g. coumadin) Active smoker Known pregnancy or lactating mother Allergies or reactions to lidocaine or epinephrine Underlying immunodeficiency Inability to comply with study requirements Pacemaker or defibrillator in place
superficial closure with PTB
Procedure: tissue bonding
superficial sutures
Procedure: sutures
application of rose bengal and treatment with green light
interrupted superficial sutures
scar appearance
Time frame: 6 months
patient satisfaction
Time frame: 6 months
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital