Medipore Tape Study

Not Applicable

Completed

• Conditions: Scarring
• Interventions: Other: Standard Post Operative Skin Care; Other: Medipore Tape

• Registration Number: NCT02676115
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Post Operative Skin Care	Standard Post Operative Skin Care
Treatment Group	Medipore Tape	Medipore Tape will be applied to ACL reconstruction Incision

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States