A Comparison of Hydrogel Dressings and Ocular Lubricants... | NCT00513734

Studies
A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

NCT00513734

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

Aug 9, 2007Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Keratitis

Interventions

Hydrogel dressing
Lacrilube ointment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Feb 2005Actual

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 9, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2007

Last Update Posted Date

Aug 9, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.

Detailed Description

Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Geliperm Hydrogel Dressing	Other: Hydrogel dressing
2	Active Comparator	Lacrilube ointment	Other: Lacrilube ointment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrogel dressing	Other	3x3cm hydrogel dressing over closed eye	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of clinically significant corneal exposure		throughout length of admission to ITU

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted to Intensive care and expected to stay for more than 2 days

Exclusion Criteria:

Primary orbital injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Healy, FRCA	Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007634	Keratitis
D014456	Ulcer

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D047070	Bandages, Hydrocolloid

Ancestor Terms

ID	Term
D001458	Bandages
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided