Medipore Tape Study

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02676115
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scarring	Other: Standard Post Operative Skin Care; Other: Medipore Tape	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Standard Post Operative Skin Care	Other: Standard 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.
Experimental: Treatment Group Medipore Tape will be applied to ACL reconstruction Incision	Other: Medipore 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.

Outcome Measures

Primary Outcome Measures

1. Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score [6 Months]

2. Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS) [6 Months]

3. Dermatology Life Quality Index (DLQI) [6 Months]

   Quantitative assessment of health-related quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 95 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Eric Strauss, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02676115
• Other Study ID Numbers: 15-00048
• First Posted: Feb 8, 2016
• Last Update Posted: Aug 8, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by NYU Langone Health: Cosmetic Wound Healing; anterior cruciate ligament (ACL)
• Additional relevant MeSH terms: Cicatrix

Study Results

No Results Posted as of Aug 8, 2016