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CompletedNCT02676115Updated Aug 8, 2016

Medipore Tape Study

An interventional study of Standard Post Operative Skin Care and Medipore Tape in Scarring, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 15 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-08.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Scarring

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Keywords

  • Cosmetic Wound Healing
  • anterior cruciate ligament (ACL)
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's enrollment of 60 is above the median of 39 across 251 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Control Group

    Standard Post Operative Skin Care

    Other: Standard Post Operative Skin Care

  • Experimental
    Treatment Group

    Medipore Tape will be applied to ACL reconstruction Incision

    Other: Medipore Tape

Interventions

  • OtherStandard 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.

  • OtherMedipore 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.

06

What researchers measure

Primary outcomes

  1. Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score

    Time frame: 6 Months

  2. Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 6 Months

  3. Dermatology Life Quality Index (DLQI)

    Quantitative assessment of health-related quality of life.

    Time frame: 6 Months

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02676115
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Feb 8, 2016
Start date
Feb 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Aug 8, 2016

Study contacts

Eric Strauss, MD
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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