Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Soft Tissue Inflammation

Treatments: Procedure: Silver Hydrocolloid Dressing; Procedure: Standard Hydrocolloid Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01501539

IRB # 2011-14460

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 3 patient groups

Standard postop gastrostomy tube care

No Intervention group

Description:

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.

Standard hydrocolloid dressing

Experimental group

Description:

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.

Treatment:

Procedure: Standard Hydrocolloid Dressing

Silver hydrocolloid dressing

Experimental group

Description:

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.

Treatment:

Procedure: Silver Hydrocolloid Dressing