Effect of Externally Implantable Tissue Expansion Device on Scar Length
This study has been withdrawn prior to enrollment.
(Inability to recruit eligible subjects)
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00798798
First received: November 24, 2008
Last updated: February 7, 2012
Last verified: February 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 24, 2008 | ||||||||
| Last Updated Date | February 7, 2012 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Surface area (in cm2) of subject's scar [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00798798 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Treating physicians will note any adverse effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Externally Implantable Tissue Expansion Device on Scar Length | ||||||||
| Official Title ICMJE | Effect of Externally Implantable Tissue Expansion Device on Scar Length | ||||||||
| Brief 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. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Skin Lesion | ||||||||
| Intervention ICMJE | Device: Externally Implantable Tissue Expansion Device
Will Apply Externally Implantable Tissue Expansion Device for 2 Days |
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| Study Arm (s) | Experimental: Implantable Tissue Expansion Device
Will apply externally implantable tissue expansion device for 2 days
Intervention: Device: Externally Implantable Tissue Expansion Device |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||
| Enrollment ICMJE | 0 | ||||||||
| Completion Date | October 2010 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00798798 | ||||||||
| Other Study ID Numbers ICMJE | MA-STU2545 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Murad Alam, Northwestern University | ||||||||
| Study Sponsor ICMJE | Northwestern University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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