Use of Morphine Gel Topically in Patients With Stage 2-3... | NCT00755989

Studies
Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds

NCT00755989

Sponsor

Banner Health

Status

Withdrawn

Last Update Posted

Jul 20, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Wounds

Interventions

None available

Countries

United States

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study {I is no longer with banner Health, please remove this study from Banner Health's list.

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 18, 2008

First Submission Date that Met QC Criteria

Sep 18, 2008

First Posted Date

Sep 19, 2008Estimated

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

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

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

Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.

Detailed Description

Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm Title 1	Other	None available - study is no longer active.	Other: None available

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None available	Other		Arm Title 1	STudy is no longer active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and efficacy with the use of morphine gel applied topically for pain control		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated consent form & HIPAA
>/= 18 yo
Single stage 2-3 wound evaluated by our wound care team
Alert and oriented (thinking ability clear and intact, physician approval)
English language proficiency, likely to be able to participate in all scheduled evaluations

Exclusion Criteria:

Allergy to morphine, codeine, or versa base
pts taking medications for acute condition, other than for the wound pain (can be taking chronic pain meds if current dose stable for past 3 mo)
Patients with neuropathies
Patients with respiratory conditions
Patients that are pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Whitmer, MSN,FNP, APRN BC-PCM	Banner Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan Medical Center		Phoenix	Arizona	85006	United States

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided