NCT00586040

Photochemical Tissue Bonding

Photochemical Tissue Bonding (PTB) for Excisional Wound Healing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Basal Cell Carcinoma
• Squamous Cell Carcinoma
• Atypical Nevus

Interventions

Type	Name	Description
PROCEDURE	tissue bonding	application of rose bengal and treatment with green light
PROCEDURE	sutures	interrupted superficial sutures

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-01-04
• Last updated: 2009-04-10

Locations

1 site across 1 country: United States