Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement

Soft Tissue Inflammation Clinical Trial

Official title:

Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501539
• Other study ID #: IRB # 2011-14460
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: February 6, 2018
• Start date: December 2010
• Est. completion date: June 2017

Study information

• Verified date: February 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Soft Tissue Inflammation

Intervention

Procedure:
• Standard Hydrocolloid Dressing
Treatment placed over insertion site.
• Silver Hydrocolloid Dressing
Place dressing against skin under gastrostomy tube

Locations

Country	Name	City	State
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.