NCT02353507

Brief Summary

The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 27, 2016

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

January 28, 2015

Last Update Submit

April 25, 2016

Conditions

Bandages

Outcome Measures

Primary Outcomes (2)

  • Wound Infection Rates

    Up to 21 days of use

  • Days required for wound healing

    Up to 21 days of use

Secondary Outcomes (1)

  • Pain Levels during Dressing Removal

    Up to 21 days

Study Arms (2)

Opticell Ag+

ACTIVE COMPARATOR

Absorbent, antibacterial, barrier dressing

Device: Opticell Ag+

Aquacel Ag+

ACTIVE COMPARATOR

Absorbent, antibacterial, barrier dressing

Device: Aquacel Ag+

Interventions

Opticell Ag+DEVICE
Opticell Ag+
Aquacel Ag+DEVICE
Aquacel Ag+

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient status at the site
  • Written consent obtained from the subject
  • Burn injury must have been incurred within 36 hours prior to enrollment.
  • Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
  • Burn injury must exceed 3% total body surface area.

You may not qualify if:

  • Subject is pregnant.
  • Bone fractures.
  • Inhalation-related trauma.
  • Sensitive and/or allergic to materials containing silver.
  • Burn injury exceeds 40% total body surface area.
  • Burn injury diagnosis indicates deep partial or full thickness wounds.
  • Burn a result of electrical/chemical injury or frostbite.
  • An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 27, 2016

Record last verified: 2015-02