Back to resultsMedipore Tape Study
Primary Purpose
Scarring
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Post Operative Skin Care
Medipore Tape
Sponsored by
About this trial
This is an interventional treatment trial for Scarring focused on measuring Cosmetic Wound Healing, anterior cruciate ligament (ACL)
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Treatment Group
Arm Description
Standard Post Operative Skin Care
Medipore Tape will be applied to ACL reconstruction Incision
Outcomes
Primary Outcome Measures
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
Dermatology Life Quality Index (DLQI)
Quantitative assessment of health-related quality of life.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02676115
Brief Title
Medipore Tape Study
Official Title
The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring
Keywords
Cosmetic Wound Healing, anterior cruciate ligament (ACL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard Post Operative Skin Care
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Medipore Tape will be applied to ACL reconstruction Incision
Intervention Type
Other
Intervention Name(s)
Standard Post Operative Skin Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Medipore Tape
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
Time Frame
6 Months
Title
Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
6 Months
Title
Dermatology Life Quality Index (DLQI)
Description
Quantitative assessment of health-related quality of life.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Strauss, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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