Silver Nitrate Application and Topical Corticosteroids fo... | NCT02398539

Studies
Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

NCT02398539

Sponsor

Akron Children's Hospital

Status

Unknown status

Last Update Posted

May 29, 2015Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Hypergranulation Tissue; Gastrostomy Tube Site

Interventions

Silver Nitrate
Triamcinolone

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

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Mar 20, 2015

First Submission Date that Met QC Criteria

Mar 20, 2015

First Posted Date

Mar 25, 2015Estimated

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

May 28, 2015

Last Update Posted Date

May 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eloise Lemon, Principal Investigator, Akron Children's HospitalPrincipal Investigator

Lead Sponsor

Akron Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:

Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.	Drug: Silver Nitrate
Group 2	Active Comparator	Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.	Drug: Triamcinolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silver Nitrate	Drug	Silver Nitrate Sticks	Group 1
Triamcinolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal reduction in granulation tissue		During maximum of 4 weeks of therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients <18
Evaluated for hypergranulation at the G-tube site
Inpatient and out-patient

Exclusion Criteria:

Children not meeting the above criteia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eloise Lemon, MSN, MHA, RN	Contact	(330) 543-3193		ELEMON@CHMCA.ORG

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akron Children's Hospital	Recruiting	Akron	Ohio	44308	United States

Intervention Browse Module

MeSH Terms

ID	Term
D012835	Silver Nitrate
D014221	Triamcinolone

Ancestor Terms

ID	Term
D009566	Nitrates
D017942	Nitric Acid
D017672	Nitrogen Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided