ScarringNCT02676115
Medipore Tape Study
A study testing Standard Post Operative Skin Care and Medipore Tape in people with Scarring, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Scarring
- What is being tested?
- Standard Post Operative Skin Care and Medipore Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction
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.
- Conditions
- Scarring
- Being tested
- Standard Post Operative Skin Care, Medipore Tape
- Keywords
- Cosmetic Wound Healing, anterior cruciate ligament (ACL)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Post Operative Skin CareOther
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 TapeOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard Post Operative Skin Care Receives: Other: Standard Post Operative Skin Care |
| Treatment Group | Experimental | Medipore Tape will be applied to ACL reconstruction Incision Receives: Other: Medipore Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
Measured: 6 Months
Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
Measured: 6 Months
Dermatology Life Quality Index (DLQI)
Quantitative assessment of health-related quality of life.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Strauss, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676115
- Sponsor's protocol ID
- 15-00048
- Status last verified
- Aug 2016
- First submitted
- 3 Feb 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Wound Taping Protocol to Improve Cosmetic Scar After Anterior Cruciate Ligament (ACL) Reconstruction
- ClinicalTrials.gov ID
- NCT02676115
- Acronym / sponsor ID
- 15-00048
- Conditions
- Scarring
- Keywords
- Cosmetic Wound Healing, anterior cruciate ligament (ACL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Post Operative Skin CareStandard Post Operative Skin Care |
| Treatment Group | Experimental | Other: Medipore TapeMedipore Tape will be applied to ACL reconstruction Incision |
Who may qualify
- Ages
- 15 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Post Operative Skin CareControl 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. | Other | 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. | Other | Treatment Group |
Primary outcome
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score
Time frame: 6 Months
Quantitative Assessment of Scar using Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 6 Months
Dermatology Life Quality Index (DLQI)
Time frame: 6 Months
Quantitative assessment of health-related quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Strauss, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Post Operative Skin Care and Medipore Tape in people with Scarring, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients' own appraisal of their scar assessed quantitatively by change in Manchester Scar Scale (MSS) Score (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.