Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

NCT ID: NCT02398539

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Hypergranulation Tissue; Gastrostomy Tube Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician.

Group Type ACTIVE_COMPARATOR

Silver Nitrate

Intervention Type DRUG

Silver Nitrate Sticks

Group 2

Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver.

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

0.5% cream

Interventions

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Silver Nitrate

Silver Nitrate Sticks

Intervention Type DRUG

Triamcinolone

0.5% cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pediatric patients \<18
2. Evaluated for hypergranulation at the G-tube site
3. Inpatient and out-patient

Exclusion Criteria

Children not meeting the above criteia
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akron Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eloise Lemon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akron Children's Hospital

Akron, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eloise Lemon, MSN, MHA, RN

Role: CONTACT

Phone: (330) 543-3193

Email: [email protected]

Facility Contacts

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Eloise Lemon

Role: primary

Other Identifiers

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150110

Identifier Type: -

Identifier Source: org_study_id