NCT03016078

Brief Summary

The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

January 4, 2017

Results QC Date

January 16, 2018

Last Update Submit

February 13, 2018

Conditions

Arthroplasties, Hip ReplacementArthroplasties, Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Damage to the Incision and Surrounding Skin

    The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: * Blistering (Yes/No) by visit * Redness under dressing (Yes/No) by visit * Redness outside dressing (Yes/No) by visit * Maceration under dressing (Yes/No) by visit * Maceration outside dressing (Yes/No) by visit

    Daily visits, up to 7 days

Secondary Outcomes (7)

  • Number of Participants With Leakage of the Dressing

    Daily visits, up to 7 days

  • Number of Participants With Dressing Sticking to the Staples/Sutures

    Daily visits, up to 7 days

  • Number of Participants With Bleeding Caused by Dressing Removal

    Daily visits, up to 7 days

  • Participants' Dressing Wear Time (Days)

    7 days

  • Number of Dressing Changes Per Subject

    Daily visits, up to 7 days

  • +2 more secondary outcomes

Study Arms (1)

Mepilex Border Post-Op Ag Dressing

OTHER

A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties

Device: Mepilex Border Post-Op Ag

Interventions

Mepilex Border Post-Op AgDEVICE

To investigate if there was any skin damage under the dressing from operation day to last visit.

Mepilex Border Post-Op Ag Dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Available for a follow-up visit including dressing change 7 days after surgery
  • Plan for elective primary hip or knee arthroplasty
  • Plan for incision size ≤18 cm
  • Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
  • Undergoing elective primary arthroplasty of the hip or knee.

You may not qualify if:

  • Known allergy/hypersensitivity to any of the components of the dressing
  • Multi-trauma
  • Undergoing arthroplasty due to tumor
  • Previous incision at the same knee or same side of the hip
  • Wound at the surgical site prior to surgery
  • Neurological deficit of operated side (hemiplegia, etc.)
  • Documented skin disease at time of enrollment, as judged by the investigator
  • Previously enrolled in the present investigation
  • Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
  • Dressing size does not fit the incision area (\>18 cm)
  • Complications that would increase wound risks if investigational dressing is applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The CORE Institute Gilbert

Gilbert, Arizona, 85297, United States

Location

Results Point of Contact

Title
Global Clinical Research Director
Organization
Mölnlycke Health Care
info@monlycke.com
+46 31 722 30 00

Study Officials

  • Steven Myerthall, Dr

    Center for Orthopedic Research and Education, The CORE Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 10, 2017

Study Start

February 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 7, 2017

Last Updated

February 14, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-02

Locations

US(1)