Photochemical Tissue Bonding

Squamous Cell Carcinoma Clinical Trial

— PTB  

Official title:

Photochemical Tissue Bonding (PTB) for Excisional Wound Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586040
• Other study ID #: 2006p001528
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: April 9, 2009
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atypical Nevus
• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Procedure:
• tissue bonding
application of rose bengal and treatment with green light
• sutures
interrupted superficial sutures

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar appearance		6 months	No
Secondary	patient satisfaction		6 months	No

External Links

•   Department of Dermatology, Massachusetts General Hospital
•   Irene E Kochevar
•   Wellman Center for Photomedicine