NCT01636362

Brief Summary

Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

6 active sites

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

June 26, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 5, 2014

Completed
Last Updated

October 7, 2014

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

June 26, 2012

Results QC Date

August 26, 2014

Last Update Submit

September 29, 2014

Conditions

BurnsWound Healing

Keywords

Partial-thickness second degree burnsMepitel AgSilver dressing

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects Healed at Day 14.

    \> = 95 % epitheliazation

    Healing will be assessed after 14 days.

  • Proportion of Subjects Healed at Day 21.

    The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.

    Healing will be assessed after 21 days.

Secondary Outcomes (1)

  • Percent of Study Burn Healed.

    At day 21

Study Arms (1)

Mepitel Ag

EXPERIMENTAL

Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Device: Mepitel Ag

Interventions

Mepitel AgDEVICE

Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Mepitel Ag

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
  • Study site is from 1-15% BSA
  • Study site is a single, isolated burn area
  • From 2 years and above
  • Thermal burn injury
  • Signed Informed Consent/Assent Form
  • Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.

You may not qualify if:

  • Completely non-exuding or dry wound bed at study site
  • Full thickness \>5%
  • Burn greater than 24 hrs old
  • Burns to face or neck
  • Suspicion of infection of study burn
  • Use of chemical/enzymatic and biological debridement within 7 days of investigation start
  • Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
  • Subject with lung injury or subject being on a ventilator
  • Subject with dermatologic skin disorders or necrotizing processes
  • Subject with insulin dependent diabetes mellitus
  • Electrical, chemical etiology
  • Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
  • Non-compliant subject
  • Subject previously included in this investigation
  • Subject included in other ongoing clinical investigation at present or during the past 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Wishard

Indianapolis, Indiana, 46202, United States

Location

Paul Silverstein, MD

Oklahoma City, Oklahoma, 73116, United States

Location

S:t Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Joan Wilson
Organization
Molnlycke Health Care AB
joan.wilson@molnlycke.com
706 504 8997

Study Officials

  • Paul Silverstein, MD

    INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
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

June 26, 2012

First Posted

July 10, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 7, 2014

Results First Posted

September 5, 2014

Record last verified: 2013-12

Locations

US(6)