Medipore Tape Study

NCT ID: NCT02676115

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scarring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Standard Post Operative Skin Care

Group Type ACTIVE_COMPARATOR

Standard Post Operative Skin Care

Intervention Type 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.

Treatment Group

Medipore Tape will be applied to ACL reconstruction Incision

Group Type EXPERIMENTAL

Medipore Tape

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric Strauss, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York University School of Medicine

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-00048

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microporous Tape and Post Surgical Scars
NCT06768047 NOT_YET_RECRUITING NA