Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01501539

Enrollment

171

Registered

2011-12-29

Start date

2010-12-31

Completion date

2017-06-30

Last updated

2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Inflammation

Keywords

Hypergranulation tissue, Gastrostomy tube, Hydrocolloid dressing, Silver hydrocolloid dressing, Gastrostomy tube dislodgement, Wound infection, Peristomal skin breakdown

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREStandard Hydrocolloid Dressing

Treatment placed over insertion site.

PROCEDURESilver Hydrocolloid Dressing

Place dressing against skin under gastrostomy tube

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 17 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The primary outcome is to measure change in Hypergranulation tissue formation around Gastrostomy tube.	2 time points: 2 weeks and 6 months post insertion.

Secondary

Measure	Time frame
The secondary outcome is to measure change in visual assessment of postoperative condition of gastrostomy tube insertion site.	2 timepoints: 2 weeks and 6 months post insertion.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026