Basal Cell CarcinomaPhase 2PTBNCT00586040
Photochemical Tissue Bonding
A Phase 2 study testing tissue bonding and sutures in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevus
- What is being tested?
- tissue bonding and sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Photochemical Tissue Bonding (PTB) for Excisional Wound Healing
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.
Read the 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.
- Being tested
- tissue bonding, sutures
- Keywords
- skin cancer, skin excision, laser, superficial sutures, wound healing
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Dysplastic Nevus Syndrome, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue bondingProcedure or surgery
application of rose bengal and treatment with green light
suturesProcedure or surgery
interrupted superficial sutures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | superficial closure with PTB Receives: Procedure: tissue bonding |
| 2 | Active comparator | superficial sutures Receives: Procedure: sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
scar appearance
Measured: 6 months
Secondary outcomes (1)
patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Irene E Kochevar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586040
- Sponsor's protocol ID
- 2006p001528
- Acronym
- PTB
- Status last verified
- Apr 2009
- First submitted
- 21 Dec 2007
- Last updated
- 10 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22032650
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photochemical Tissue Bonding (PTB) for Excisional Wound Healing
- ClinicalTrials.gov ID
- NCT00586040
- Acronym / sponsor ID
- PTB / 2006p001528
- Keywords
- skin cancer, skin excision, laser, superficial sutures, wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: tissue bondingsuperficial closure with PTB |
| 2 | Active comparator | Procedure: suturessuperficial sutures |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue bondingapplication of rose bengal and treatment with green light | Procedure or surgery | 1 |
| suturesinterrupted superficial sutures | Procedure or surgery | 2 |
Primary outcome
scar appearance
Time frame: 6 months
1 secondary outcome
patient satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
- Derived from this study: PubMed 22032650Tsao 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.
- Wellman Center for PhotomedicineLink provided by the sponsor.
- Department of Dermatology, Massachusetts General HospitalLink provided by the sponsor.
- Irene E KochevarLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene E Kochevar, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tissue bonding and sutures in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scar appearance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2009.