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Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

Primary Purpose

Non-melanoma Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pressure Dressing
Simple Adhesive Dressing
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-melanoma Skin Cancer focused on measuring Pressure Dressing, Post-operative Care, Simple Adhesive Dressing, Mohs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer.

Exclusion Criteria:

  • Lack of indication for Mohs
  • Significant comorbidities
  • Case of a high-risk location or tumor size which necessitates consultation with other specialties in advance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Pressure Dressing

    Simple Adhesive Dressing

    Arm Description

    Participants randomized to this group will receive the standard post-operative dressing following their Mohs procedure: a pressure dressing consisting of high absorbency gauze and retention tape.

    Participants randomized to this group will receive the experimental post-operative dressing following their Mohs procedure: a simple adhesive dressing consisting of a non-adherent pad and transparent dressing.

    Outcomes

    Primary Outcome Measures

    Patient Satisfaction
    Patients are asked to complete a survey regarding their satisfaction with their post-operative dressing. Surveys will be distributed at their first clinical follow-up visit. They are asked to rate their overall satisfaction and difficulty sleeping, bathing, and returning to normal activity following their Mohs procedure.
    Complications
    The number of complications requiring medical attention in each arm of the study. These complications include: infection, bleeding, wound dehiscence, splitting or retained stitches, pain, and cosmetic disfigurement.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    August 18, 2016
    Sponsor
    Dartmouth-Hitchcock Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02780934
    Brief Title
    Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction
    Official Title
    Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dartmouth-Hitchcock Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether using a pressure- vs. simple adhesive dressing affects the postoperative course and wound healing outcomes following Mohs surgery.
    Detailed Description
    The investigators will randomize patients undergoing Mohs surgery to receive either a pressure or a simple adhesive dressing following their procedure. The hypothesis is that patients with the simple adhesive dressings will be more satisfied and comfortable with their wound care on follow-up. These patients are also expected to cite greater convenience managing the simple dressing at home. Finally, the investigators anticipate no difference in the number of postoperative complications between the two groups and expect that there will be a lower cost associated with the simple adhesive dressing as compared to the pressure dressing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-melanoma Skin Cancer
    Keywords
    Pressure Dressing, Post-operative Care, Simple Adhesive Dressing, Mohs

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pressure Dressing
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to this group will receive the standard post-operative dressing following their Mohs procedure: a pressure dressing consisting of high absorbency gauze and retention tape.
    Arm Title
    Simple Adhesive Dressing
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this group will receive the experimental post-operative dressing following their Mohs procedure: a simple adhesive dressing consisting of a non-adherent pad and transparent dressing.
    Intervention Type
    Other
    Intervention Name(s)
    Pressure Dressing
    Intervention Description
    Patients in this group will receive the standard post-operative bandage: a pressure dressing consisting of high absorbency gauze and retention tape.
    Intervention Type
    Other
    Intervention Name(s)
    Simple Adhesive Dressing
    Intervention Description
    Patients in this group will receive the experimental bandage: a simple adhesive dressing consisting of a non adherent pad and transparent dressing.
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction
    Description
    Patients are asked to complete a survey regarding their satisfaction with their post-operative dressing. Surveys will be distributed at their first clinical follow-up visit. They are asked to rate their overall satisfaction and difficulty sleeping, bathing, and returning to normal activity following their Mohs procedure.
    Time Frame
    Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure
    Title
    Complications
    Description
    The number of complications requiring medical attention in each arm of the study. These complications include: infection, bleeding, wound dehiscence, splitting or retained stitches, pain, and cosmetic disfigurement.
    Time Frame
    Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer. Exclusion Criteria: Lack of indication for Mohs Significant comorbidities Case of a high-risk location or tumor size which necessitates consultation with other specialties in advance.

    12. IPD Sharing Statement

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    Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

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