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Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

This study is currently recruiting participants.
Verified November 2011 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01501539
First received: December 20, 2011
Last updated: December 27, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypergranulation Tissue
 Procedure: Standard Hydrocolloid Dressing
Procedure: Standard of Care
Procedure: Silver Hydrocolloid Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 171
Study Start Date: December 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard postop gastrostomy tube care
At the completion of the operative procedure for gastrostomy tube placement, he surgical incisions and the gastrostomy tube will be covered with dermabond, steristrips, and/or tegaderm dressings, according to surgeon preference.
 Procedure: Standard of Care
Insertion site cleaned with soap and water. No dressing added.
Other Name: Standard postop gastrostomy tube care
Experimental: Standard hydrocolloid dressing
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 60 days after gastrostomy tube placement. After 60 days, care will revert to standard care.
 Procedure: Standard Hydrocolloid Dressing
Treatment placed over insertion site.
Other Names:
  • FDA Class II-K medical products
  • Hollister Wound Care (Hollister Incorporated)
Experimental: Silver hydrocolloid dressing
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 60 days after gastrostomy tube placement. After 60 days, care will revert to standard care.
 Procedure: Silver Hydrocolloid Dressing
Place dressing against skin under gastrostomy tube
Other Names:
  • FDA Class II-K medical products
  • Hollister Wound Care (Hollister Incorporated)

  Eligibility

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501539

Contacts
Contact: Andrea Chen, MS 773-880-8139 ajchen@childrensmemorial.org

Locations
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Principal Investigator: Katherine A Barsness, MD            
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Katherine A Barsness, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01501539     History of Changes
Other Study ID Numbers: IRB # 2011-14460
Study First Received: December 20, 2011
Last Updated: December 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Hypergranulation tissue
Gastrostomy tube
Hydrocolloid dressing
Silver hydrocolloid dressing
 Gastrostomy tube dislodgement
Wound infection
Peristomal skin breakdown

ClinicalTrials.gov processed this record on May 21, 2013