Clinical trial NCT01501539: Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement
Official title: Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Inflammation
Keywords: Hypergranulation tissue
Gastrostomy tube
Hydrocolloid dressing
Silver hydrocolloid dressing
Gastrostomy tube dislodgement
Wound infection
Peristomal skin breakdown
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 171
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The primary outcome is to measure change in Hypergranulation tissue formation around Gastrostomy tube.
timeFrame: 2 time points: 2 weeks and 6 months post insertion.
Secondary outcomes:
measure: The secondary outcome is to measure change in visual assessment of postoperative condition of gastrostomy tube insertion site.
timeFrame: 2 timepoints: 2 weeks and 6 months post insertion.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Katherine A Barsness, MD
role: PRINCIPAL_INVESTIGATOR
References: