Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Information provided by (Responsible Party):
Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01501539
First received: December 20, 2011
Last updated: November 11, 2015
Last verified: November 2015
  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
Soft Tissue Inflammation
Procedure: Standard Hydrocolloid Dressing
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: July 2016 (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, 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.
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 30 days after gastrostomy tube placement. After 30 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 30 days after gastrostomy tube placement. After 30 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)

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

Ages Eligible for Study:   1 Month to 17 Years   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501539

Contacts
Contact: Talin Robinson, MS 312-227-4733 trobinson@luriechildens.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

Responsible Party: Katherine Barsness, MD, Attending Physician, Department of Surgery, 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: November 11, 2015
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

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 22, 2016