Photochemical Tissue Bonding (PTB)

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00586040
First received: December 21, 2007
Last updated: April 9, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Basal Cell Carcinoma
Squamous Cell Carcinoma
Atypical Nevus
Procedure: tissue bonding
Procedure: sutures
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photochemical Tissue Bonding (PTB) for Excisional Wound Healing

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • scar appearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00586040

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

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irene E. Kochevar, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00586040     History of Changes
Other Study ID Numbers: 2006p001528
Study First Received: December 21, 2007
Last Updated: April 9, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Dysplastic Nevus Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Nevus
Nevi and Melanomas
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 23, 2014