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Photochemical Tissue Bonding (PTB) for Excisional Wound Healing


Phase 2
20 Years
60 Years
Not Enrolling
Both
Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevus

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Trial Information

Photochemical Tissue Bonding (PTB) for Excisional Wound Healing


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

scar appearance

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Irene E Kochevar, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

2006p001528

NCT ID:

NCT00586040

Start Date:

September 2007

Completion Date:

April 2009

Related Keywords:

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Atypical Nevus
  • skin cancer
  • skin excision
  • laser
  • superficial sutures
  • wound healing
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Dysplastic Nevus Syndrome

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617