NCT01289340

Brief Summary

the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
4.7 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

February 2, 2011

Last Update Submit

October 6, 2020

Conditions

Pain

Keywords

wound healingpainburn

Outcome Measures

Primary Outcomes (1)

  • complete wound healing

    final burn wound closure

    up to two to three weeks

Study Arms (3)

Polymem (R)

superficial burns treated with Polymem wound dressing until complete wound healing

Biaten IBU

burns treated with Biaten IBU until complete wound healing.

Hartmen dressing

burns treated with hartman or saline wet dressing until wound healing

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients ages 18-40 with no co-morbidities nor pregnant.

You may qualify if:

  • patients with minor superficial partial thickness burns

You may not qualify if:

  • co-morbidities, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beilinson hospital, RMC

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

PainBurns

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Dean D Ad El, MD

    Rabin medcial Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 3, 2011

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

March 1, 2017

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IL(1)