Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

Non-melanoma Skin Cancer Clinical Trial

Official title:

Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780934
• Other study ID #: CPHS# 29015
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: August 18, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Other:
• Pressure Dressing
Patients in this group will receive the standard post-operative bandage: a pressure dressing consisting of high absorbency gauze and retention tape.
• Simple Adhesive Dressing
Patients in this group will receive the experimental bandage: a simple adhesive dressing consisting of a non adherent pad and transparent dressing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure	No
Primary	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.	Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure	Yes