Medipore Tape Study

Scarring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676115
• Other study ID #: 15-00048
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: August 4, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Scarring

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score		6 Months	No
Primary	Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)		6 Months	No
Primary	Dermatology Life Quality Index (DLQI)	Quantitative assessment of health-related quality of life.	6 Months	No