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Completed

NCT Number: NCT01501539

Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

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.

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Key information

Conditions

Soft Tissue Inflammation Infections Wound Infection

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Hydrocolloid Dressing

Procedure

Treatment placed over insertion site.

Other names: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)

Silver Hydrocolloid Dressing

Procedure

Place dressing against skin under gastrostomy tube

Other names: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)

Primary outcomes

  1. The primary outcome is to measure change in Hypergranulation tissue formation around Gastrostomy tube.

    Time frame: 2 time points: 2 weeks and 6 months post insertion.

Secondary outcomes

  1. The secondary outcome is to measure change in visual assessment of postoperative condition of gastrostomy tube insertion site.

    Time frame: 2 timepoints: 2 weeks and 6 months post insertion.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2011
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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