Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
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| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2011 | ||||
| Last Updated Date | October 10, 2012 | ||||
| Start Date ICMJE | February 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Visual Analog Scale (VAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ] The Visual Analog or Analogue Scale (VAS)* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style. The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound.
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| Original Primary Outcome Measures ICMJE |
Evidence of superior cosmetic and functional outcome with cyanoacrylate vs fast absorbing gut [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01298167 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery | ||||
| Official Title ICMJE | Fast Absorbing Gut Suture Versus Cyanoacrylate Tissue Adhesive in the Epidermal Closure of Linear Repairs Following Mohs Micrographic Surgery | ||||
| Brief Summary | The purpose of the study is to look at which nonpermanent superficial closure method, cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and functional outcome in repairs of facial wounds after Mohs surgery. |
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| Detailed Description | Cyanoacrylate is a rapidly polymerizing topical adhesive commonly used as an alternative to traditional sutures. Both cyanoacrylate and fast absorbing gut suture eliminate the need for suture removal which can represent a significant savings in patient and staff time as well as related healthcare resources. Both cyanoacrylate and fast absorbing gut suture are currently routinely used for epidermal closure at Yale following Mohs micrographic surgery. Physician preference currently dictates which epidermal closure method is chosen for a given surgery. Cyanoacrylate has been reported to decrease trauma to the epidermal edges, minimize suture tract marks in surgical scars, and decrease the risk of inflammatory reaction to suture material. Cyanoacrylate, however, does not allow for wound eversion. Wound eversion minimizes the risk of a depressed scar from tissue contraction during healing. As with all sutures, fast absorbing gut suture allows for wound eversion which is reported to maximize the likelihood of a good epidermal approximation. On the other hand, fast absorbing gut suture degrades by proteolysis which can result in an inflammatory reaction. Any inflammatory reaction on the skin while healing can affect the final cosmetic outcome (ie. post-inflammatory hyperpigmentation). A recent article (Tierney 2009), reported that tissue adhesive may not be as effective in achieving optimal cosmesis as fast absorbing gut for defects on the trunk and extremities. However, we would like to study these two methods for the repair of facial wounds, which are in low tension areas as compared to trunk and extremities. Therefore, it is unknown exactly which of these two method is better than the other in epidermal closure of facial wounds follow Mohs micrographic surgery. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Cyanoacrylate tissue glue versus Fast absorbing gut
All wounds will be closed using a linear, bilayered closure method, where the buried intradermal absorbing suture (5-0, Polysorb) will be placed along the length of the incision, consistent with standard surgical procedure. Only patients with wounds with a length of 3cm or greater will be enrolled. Each wound will be measured, and the length divided in half. Half of the surgical wound will be randomly selected (by coin toss) for epidermal reapproximation with cyanoacrylate, whereas the other half will be repaired with 6-0 fast absorbing gut suture in standard running fashion. |
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| Study Arm (s) |
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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 | Completed | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT01298167 | ||||
| Other Study ID Numbers ICMJE | 1101007845 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Yale University | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | October 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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