Clinical trial NCT00586040: Photochemical Tissue Bonding
Official title: Photochemical Tissue Bonding (PTB) for Excisional Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Atypical Nevus
Keywords: skin cancer
skin excision
laser
superficial sutures
wound healing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histopathology confirmed basal cell carcinoma or well-differentiated squamous cell carcinoma without subcutaneous fat invasion on the chest, arm or abdomen or a diagnosis of atypical or dysplastic nevi on the chest, arm or abdomen.
* Able to follow involved post-operative care instructions
* Able to comply with study requirements
* Age 20-60 years

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

Primary outcomes:
measure: scar appearance
timeFrame: 6 months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Irene E Kochevar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsao S, Yao M, Tsao H, Henry FP, Zhao Y, Kochevar JJ, Redmond RW, Kochevar IE. Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Br J Dermatol. 2012 Mar;166(3):555-63. doi: 10.1111/j.1365-2133.2011.10710.x. Epub 2012 Jan 19.