Soft Tissue InflammationNCT01501539
Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement
A study testing Standard Hydrocolloid Dressing and Silver Hydrocolloid Dressing in people with Soft Tissue Inflammation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Soft Tissue Inflammation
- What is being tested?
- Standard Hydrocolloid Dressing and Silver Hydrocolloid Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings
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.
Read the 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.
- Conditions
- Soft Tissue Inflammation
- Being tested
- Standard Hydrocolloid Dressing, Silver Hydrocolloid Dressing
- Keywords
- Hypergranulation tissue, Gastrostomy tube, Hydrocolloid dressing, Silver hydrocolloid dressing, Gastrostomy tube dislodgement, Wound infection, Peristomal skin breakdown
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Hydrocolloid DressingProcedure or surgery
Also called FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)
Treatment placed over insertion site.
Silver Hydrocolloid DressingProcedure or surgery
Also called FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)
Place dressing against skin under gastrostomy tube
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Silver Hydrocolloid Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to measure change in Hypergranulation tissue formation around Gastrostomy tube.
Measured: 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.
Measured: 2 timepoints: 2 weeks and 6 months post insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Barsness, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Katherine A Barsness, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501539
- Sponsor's protocol ID
- IRB # 2011-14460
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2011
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement: A Randomized Controlled Trial of Hydrocolloid Dressings
- ClinicalTrials.gov ID
- NCT01501539
- Acronym / sponsor ID
- IRB # 2011-14460
- Conditions
- Soft Tissue Inflammation
- Keywords
- Hypergranulation tissue, Gastrostomy tube, Hydrocolloid dressing, Silver hydrocolloid dressing, Gastrostomy tube dislodgement, Wound infection, Peristomal skin breakdown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Standard Hydrocolloid DressingAt 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. |
| Silver hydrocolloid dressing | Experimental | Procedure: Silver Hydrocolloid DressingAt 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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Hydrocolloid DressingAlso: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)Treatment placed over insertion site. | Procedure or surgery | Standard hydrocolloid dressing |
| Silver Hydrocolloid DressingAlso: FDA Class II-K medical products, Hollister Wound Care (Hollister Incorporated)Place dressing against skin under gastrostomy tube | Procedure or surgery | Silver hydrocolloid dressing |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Barsness, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Hydrocolloid Dressing and Silver Hydrocolloid Dressing in people with Soft Tissue Inflammation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.