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Photochemical Tissue Bonding (PTB)

Primary Purpose

Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tissue bonding
sutures
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring skin cancer, skin excision, laser, superficial sutures, wound healing

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

superficial closure with PTB

superficial sutures

Outcomes

Primary Outcome Measures

scar appearance

Secondary Outcome Measures

patient satisfaction

Full Information

First Posted
December 21, 2007
Last Updated
April 9, 2009
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00586040
Brief Title
Photochemical Tissue Bonding
Acronym
PTB
Official Title
Photochemical Tissue Bonding (PTB) for Excisional Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevus
Keywords
skin cancer, skin excision, laser, superficial sutures, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
superficial closure with PTB
Arm Title
2
Arm Type
Active Comparator
Arm Description
superficial sutures
Intervention Type
Procedure
Intervention Name(s)
tissue bonding
Intervention Description
application of rose bengal and treatment with green light
Intervention Type
Procedure
Intervention Name(s)
sutures
Intervention Description
interrupted superficial sutures
Primary Outcome Measure Information:
Title
scar appearance
Time Frame
6 months
Secondary Outcome Measure Information:
Title
patient satisfaction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene E Kochevar, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22032650
Citation
Tsao S, Yao M, Tsao H, Henry FP, Zhao Y, Kochevar JJ, Redmond RW, Kochevar IE. Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Br J Dermatol. 2012 Mar;166(3):555-63. doi: 10.1111/j.1365-2133.2011.10710.x. Epub 2012 Jan 19.
Results Reference
derived
Links:
URL
http://www.massgeneral.org/wellman/
Description
Wellman Center for Photomedicine
URL
http://www.mgh.harvard.edu/mghdermatology/
Description
Department of Dermatology, Massachusetts General Hospital

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Photochemical Tissue Bonding

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