Photochemical Tissue Bonding (PTB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586040
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : April 10, 2009
Information provided by:
Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Squamous Cell Carcinoma Atypical Nevus Procedure: tissue bonding Procedure: sutures Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photochemical Tissue Bonding (PTB) for Excisional Wound Healing
Study Start Date : September 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1
superficial closure with PTB
Procedure: tissue bonding
application of rose bengal and treatment with green light

Active Comparator: 2
superficial sutures
Procedure: sutures
interrupted superficial sutures

Primary Outcome Measures :
  1. scar appearance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: 6 months ]

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586040

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Irene E Kochevar, PhD Massachusetts General Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Irene E. Kochevar, Massachusetts General Hospital Identifier: NCT00586040     History of Changes
Other Study ID Numbers: 2006p001528
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009

Keywords provided by Massachusetts General Hospital:
skin cancer
skin excision
superficial sutures
wound healing

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Basal Cell