Skin LesionNCT00798798
Effect of Externally Implantable Tissue Expansion Device on Scar Length
A study testing Externally Implantable Tissue Expansion Device in people with Skin Lesion, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin Lesion
- What is being tested?
- Externally Implantable Tissue Expansion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2010
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ages 18-80 years old
- Subjects who are undergoing an excision of a large cutaneous lesion
- Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
- Subjects undergoing surgery on the trunk or extremities
- The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
- Subjects who are willing to undergo no other treatments for the scars for the duration of the study.
Who cannot join
- Subjects with scalp wounds
- Subjects who are unable to understand the protocol or give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Dermatology
Chicago, Illinois, 60611
About this study
The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.
- Conditions
- Skin Lesion
- Being tested
- Externally Implantable Tissue Expansion Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Externally Implantable Tissue Expansion DeviceDevice
Will Apply Externally Implantable Tissue Expansion Device for 2 Days
| Study group | Role | What they receive |
|---|---|---|
| Implantable Tissue Expansion Device | Experimental | Will apply externally implantable tissue expansion device for 2 days Receives: Device: Externally Implantable Tissue Expansion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface area (in cm2) of subject's scar
Measured: 3 months
Secondary outcomes (1)
Treating physicians will note any adverse effects
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Inability to recruit eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798798
- Sponsor's protocol ID
- MA-STU2545
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2008
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Externally Implantable Tissue Expansion Device on Scar Length
- ClinicalTrials.gov ID
- NCT00798798
- Acronym / sponsor ID
- MA-STU2545
- Conditions
- Skin Lesion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit eligible subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Nov 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 purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable Tissue Expansion Device | Experimental | Device: Externally Implantable Tissue Expansion DeviceWill apply externally implantable tissue expansion device for 2 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ages 18-80 years old
- Subjects who are undergoing an excision of a large cutaneous lesion
- Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
- Subjects undergoing surgery on the trunk or extremities
- The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Key exclusion criteria (2 listed)
- Subjects with scalp wounds
- Subjects who are unable to understand the protocol or give informed consent
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 |
|---|---|---|
| Externally Implantable Tissue Expansion DeviceWill Apply Externally Implantable Tissue Expansion Device for 2 Days | Device | Implantable Tissue Expansion Device |
Primary outcome
Surface area (in cm2) of subject's scar
Time frame: 3 months
1 secondary outcome
Treating physicians will note any adverse effects
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Externally Implantable Tissue Expansion Device in people with Skin Lesion, run by Northwestern University 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 3 Dec 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Surface area (in cm2) of subject's scar (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2021.