Medipore Tape Study

August 4, 2016 updated by: NYU Langone Health

The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction

This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic, effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve cosmetic wound healing and scaring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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

15 years to 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing arthroscopic ACL reconstruction with bone-patella-tendon-bone autograft at the Ambulatory Surgical Center and Hospital for Joint Diseases will be eligible for enrollment.
  • Patient is indicated for ACL reconstructive surgery with bone-patella-tendon-bone autograft

Exclusion Criteria:

  • Subjects/Parents who are mentally impaired and are unable to give consent
  • Patients with prior vertical anterior knee incisions
  • Patients with known skin reactions to adhesive
  • Patients with high risk for abnormal scar formation and keloids

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Standard Post Operative Skin Care
Other: Standard Post Operative Skin Care
Control group subjects will receive the standard post-operative skin care which are steri-strips covered with gauze, and this will be removed at the first visit. No additional skin dressings will be used in the control group.
Experimental: Treatment Group
Medipore Tape will be applied to ACL reconstruction Incision
Other: Medipore Tape
  • One layer of Medipore tape will be placed across the incision.
  • Patients will be instructed on how to change the tape, and will be encouraged to change the tape as often as once per week for hygiene.

When patients return to the office for their regularly scheduled visit, the Medipore tape will be changed and a picture of the scar will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
Time Frame: 6 Months
6 Months
Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 6 Months
6 Months
Dermatology Life Quality Index (DLQI)
Time Frame: 6 Months
Quantitative assessment of health-related quality of life.
6 Months

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Eric Strauss, MD, New York University Medical School

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

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00048

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.

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