Medipore Tape Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Scarring

Intervention / Treatment
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* Other: Standard Post Operative Skin Care
* Other: Medipore Tape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Standard Post Operative Skin Care | Other: Standard Post Operative Skin Care<br>* 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.<br>|
| Experimental: Treatment Group<br>Medipore Tape will be applied to ACL reconstruction Incision | Other: Medipore Tape<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmetic Wound Healing, anterior cruciate ligament (ACL)