Photochemical Tissue Bonding

Phase 2

Completed

• Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma; Atypical Nevus
• Interventions: Procedure: tissue bonding; Procedure: sutures

• Registration Number: NCT00586040
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tissue bonding	superficial closure with PTB
2	sutures	superficial sutures

Primary Outcome Measures

Name	Time	Method
scar appearance	6 months

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	6 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States