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Completed

NCT Number: NCT02676115

Medipore Tape Study

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.

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Key information

Conditions

Scarring Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Post Operative Skin Care

Other

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.

Medipore Tape

Other
  • 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 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)

    Time frame: 6 Months

    Quantitative assessment of health-related quality of life.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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