Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

NCT02780934 | Completed

• 1 other identifier: CPHS# 29015
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-melanoma Skin Cancer

Keywords

Pressure Dressing; Post-operative Care; Simple Adhesive Dressing; Mohs

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Pressure Dressing

ACTIVE COMPARATOR

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.

Other: Pressure Dressing

Simple Adhesive Dressing

EXPERIMENTAL

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.

Other: Simple Adhesive Dressing

Interventions

Pressure Dressing OTHER

Patients in this group will receive the standard post-operative bandage: a pressure dressing consisting of high absorbency gauze and retention tape.

Pressure Dressing

Simple Adhesive Dressing OTHER

Patients in this group will receive the experimental bandage: a simple adhesive dressing consisting of a non adherent pad and transparent dressing.

Simple Adhesive Dressing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 24, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08