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
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
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
NCT ID
NCT02780934
First Posted
May 18, 2016
Last Updated
August 18, 2016
Sponsor
Dartmouth-Hitchcock Medical Center
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
Learn more about this trial
Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction
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