Photochemical Tissue Bonding

Study Overview
=================
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.

Official Title
-----------------
Photochemical Tissue Bonding (PTB) for Excisional Wound Healing

Conditions
-----------------
Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevus

Intervention / Treatment
-----------------
* Procedure: tissue bonding
* Procedure: sutures


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>superficial closure with PTB | Procedure: tissue bonding<br>* application of rose bengal and treatment with green light<br>|
| Active Comparator: 2<br>superficial sutures | Procedure: sutures<br>* interrupted superficial sutures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar appearance |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin cancer, skin excision, laser, superficial sutures, wound healing