Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction

August 18, 2016 updated by: Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pressure Dressing
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
Patients in this group will receive the standard post-operative bandage: a pressure dressing consisting of high absorbency gauze and retention tape.
EXPERIMENTAL: Simple Adhesive Dressing
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
Patients in this group will receive the experimental bandage: a simple adhesive dressing consisting of a non adherent pad and transparent dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure
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
Time Frame: Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (ESTIMATE)

May 24, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPHS# 29015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-melanoma Skin Cancer

Clinical Trials on Pressure Dressing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe