Photochemical Tissue Bonding (PTB)
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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 |
- scar appearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| 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 May 23, 2013