Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

NCT01501539 | Completed

• 1 other identifier: IRB # 2011-14460
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Standard postop gastrostomy tube care

NO INTERVENTION

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

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.

Procedure: Standard Hydrocolloid Dressing

Silver hydrocolloid dressing

EXPERIMENTAL

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.

Procedure: Silver Hydrocolloid Dressing

Interventions

Standard Hydrocolloid Dressing PROCEDURE

Treatment placed over insertion site.

Also known as: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)

Standard hydrocolloid dressing

Silver Hydrocolloid Dressing PROCEDURE

Place dressing against skin under gastrostomy tube

Also known as: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)

Silver hydrocolloid dressing

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Katherine A Barsness, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Surgery

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)