Medipore Tape Study

NCT02676115 | Completed

• 1 other identifier: 15-00048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Scarring

Keywords

Cosmetic Wound Healing; anterior cruciate ligament (ACL)

Outcome Measures

Primary Outcomes (3)

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

  6 Months

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

  6 Months

• Dermatology Life Quality Index (DLQI)

  Quantitative assessment of health-related quality of life.

  6 Months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard Post Operative Skin Care

Other: Standard Post Operative Skin Care

Treatment Group

EXPERIMENTAL

Medipore Tape will be applied to ACL reconstruction Incision

Other: Medipore Tape

Interventions

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.

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.

Treatment Group

Eligibility Criteria

• Age: 15 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Strauss, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 8, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (1)