Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to compare the incidence of postoperative hypergranulation tissue formation after gastrostomy tube placement among children randomized to one of three treatments, in addition to measuring tube dislodgements and rates of resource utilization for complications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children

NCT07300865

Gastrostomy Complications Gastrostomy Size Food Intolerance +1 more

RECRUITING NA

Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

NCT04287647

Gastroparesis

RECRUITING NA

Comparative Anti-Reflux Procedures in Neurologically Impaired Children

NCT01307982

Gastroesophageal Reflux Nervous System Diseases Fundoplication +1 more

COMPLETED NA

Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique

NCT04096456

Gastrostomy Gastrostomy Complications Gastrostomy Tube Site Complication +1 more

UNKNOWN

Nasogastric Tube Clamping Trial vs. Immediate Removal

NCT04001985

Small Bowel Obstruction Ileus

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypergranulation tissue is one of the major immediate complications of gastronomy tube placement. This study aims to determine if using a foam dressing upon placement will prevent its formation, as it has been demonstrated as an effective treatment in healing hypergranulation tissue formation post-operatively. Study participants will be randomized into one of three treatments after gastronomy tube placement (1) standard care, (2) plain foam treatment or (3) silver foam dressing. These treatments will be applied for 30 days post-operatively in addition to standard care of cleaning the gastronomy site daily with soap and water, if assigned to foam intervention. All study materials are free for duration of 30 day intervention and participation will not interfere with routine post-operative care of gastronomy tube site. The total duration of trial will be 6 months and will not require additional study visits outside of routine care. The rate of G-tube dislodgements and associated outcomes will also be measured during the trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard postop gastrostomy tube care

At the completion of the operative procedure for gastrostomy tube placement, the surgical incisions and the gastrostomy tube will be covered with dermabond, steristrips, and/or tegaderm dressings, according to surgeon preference. Standard postop gastrostomy tube care. Insertion site cleaned with soap and water. No dressing added.

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard hydrocolloid dressing

At the completion of the operative procedure for gastrostomy tube placement, the surgical incisions will be covered with dermabond, steristrips, and/or tegaderm dressings, according to the surgeons preference. The gastrostomy tube will have a thin layer of hydrocolloid dressing (HD) placed around the gastrostomy tube. The HD will be changed once every other day fo the first 30 days after gastrostomy tube placement. After 30 days, care will revert to standard care.

Group Type EXPERIMENTAL

Standard Hydrocolloid Dressing

Intervention Type PROCEDURE

Treatment placed over insertion site.

Silver hydrocolloid dressing

At the completion of the operative procedure for gastrostomy tube placement, the surgical incisions will be covered with dermabond, steristrips, and/or tegaderm dressings, according to surgeon preference. The gastrostomy tube will have a thin layer of silver hydrocolloid dressing (HD) placed around the gastrostomy tube. The silver HD will be changed once every other day for the first 30 days after gastrostomy tube placement. After 30 days, care will revert to standard care.

Group Type EXPERIMENTAL

Silver Hydrocolloid Dressing

Intervention Type PROCEDURE

Place dressing against skin under gastrostomy tube

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Hydrocolloid Dressing

Treatment placed over insertion site.

Intervention Type PROCEDURE

Silver Hydrocolloid Dressing

Place dressing against skin under gastrostomy tube

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FDA Class II-K medical products Hollister Wound Care (Hollister Incorporated) FDA Class II-K medical products Hollister Wound Care (Hollister Incorporated)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children between 1 month and 17 years of age who undergo gastrostomy tube placement by a member of the pediatric surgery faculty at Children's Memorial Hospital will be eligible for inclusion in this study.

Exclusion Criteria

* Children undergoing gastrostomy tube placement by gastroenterology or interventional radiology at Children's Memorial Hospital.
* Mother or caregiver of the patient is currently pregnant, breastfeeding and/or planning on getting pregnant within the next 60 days (silver HD has not been studied in pregnant or breastfeeding women)

Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No