Clinical trial NCT02519738
Conditions: Other Abnormal Granulation Tissue Nos
Sponsor: University of Michigan
Start date: 2015-01-15; Completion date: 2018-11-13
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common problem seen in the pediatric surgery population. There is no standard treatment that has been identified in clinical practice to treat granulation tissue effectively. Clinicians prescribe treatments of varying nature to help treat this condition. By conducting this study, the investigators hope to identify if there is any difference in the treatment groups and if there is any superiority for one treatment over the other. The three arms in the study are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will continue over a period of three weeks, and the progress will be followed using surveys and photographs.

Detailed description:
Hypergranulation tissue surrounding gastrostomy tube sites in pediatric patients is a significant problem. This tissue may cause drainage or bleeding that bothers patients and parents. Numerous methods of treatment are used for treatment of hypergranulation tissue, but no data exists to support one method of treatment over another. The investigators plan to perform a prospective randomized trial of three different therapies (silver nitrate cauterization, topical kenalog, and soap cloth abrasion) to identify the best treatment modality. Participants will be followed via office visit at four and eight weeks after initiation of therapy. Measurements of the granulation tissue and photographs will be obtained pre treatment and at each post treatment visit. In addition parents will be asked to fill out a pre and post treatment survey regarding improvement in symptoms. Investigators plan to enroll 120 patients total with the intention of having 40 participants in each group.

Arms: arm 1: Silver Nitrate is supplied in the form of pre-packaged applicator sticks to parents and patients. The concentration is 75% Silver Nitrate and 25% Potassium Nitrate. Application will be done 3 times a week for a period of 3 weeks. arm 2: Kenalog is a topical corticosteroid that shares anti-inflammatory, anti-pruritic, and vasoconstrictive actions.The dosage of Kenalog used in the study is 0.5%. Application is topical, and the frequency is 3 times a day for the 3 week trial period. FDA approved use of Kenalog in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It has not been studied whether Kenalog has any proven advantage over Silver nitrate in the treatment of granulation tissue, but it has been used for the treatment of granulation tissue at the gastrostomy site with good effect. arm 3: Washcloth abrasion will be done with regular soap and water applied to a washcloth. The granulation tissue will be gently washed and abraded once daily for three weeks.
Interventions: intervention 1: Silver Nitrate intervention 2: Kenalog (Triamcinolone) intervention 3: Washcloth Abrasion
Intervention descriptions: intervention 1: Silver nitrate to be applied 3 times weekly for a period of 3 weeks. intervention 2: Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks. intervention 3: Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
Principal Investigator: Ronald Hirschl, MD 
 
IRB Project Title: Granulation tissue at G tube site: treatment with Kenalog vs 
chemical cauterization with Silver Nitrate vs soap washcloth abrasion 
 
Site(s) where study will be performed: C.S. Mott Children’s Hospital 
 
Protocol Version 1.0 
 
 
IRB approval date: 11/12/2021 
 
NCT02519738 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
PROTOCOL 
 
Principal Investigator: Ronald Hirschl, MD 
IRB Project Title: Granulation tissue at G tube site: treatment with Kenalog vs chemical 
cauterization with Silver Nitrate vs soap washcloth abrasion 
Site(s) where study will be performed: C.S. Mott Children’s Hospital 
Protocol Version 1.0  
 
1.0 
Introduction - Background and Rationale: Hypergranulation tissue surrounding gastrostomy 
tube sites in pediatric patients is a significant problem. This tissue may cause drainage or bleeding 
that bothers patients and parents. Numerous methods of treatment are used for treatment of 
hypergranulation tissue, but no data exists to support one method of treatment over another. We 
plan to perform a prospective randomized trial of three different therapies (silver nitrate 
cauterization, topical kenalog, and soapcloth abrasion) to identify the best treatment modality. 
Steroids topically or by intralesional injection has been used to control granulation or 
hypertrophied scars/keloid. A pertinent reference pertaining to the use of kenalog are as follows: 
 
Lahiri A, Tsiliboti D and Gaze NR.Experience with difficult keloids. 
British J of Plastic Surgery. 2001; 54(7):633-635 
 
We will follow the patients via office visit at four and eight weeks after initiation of therapy. 
Measurements of the granulation tissue and photographs will be obtained pre treatment and at 
each post treatment visit. In addition parents will be asked to fill out a pre and post treatment 
survey regarding improvement in symptoms. We plan to enroll 120 patients total with the intention 
of having 40 participants in each group.  
 
2.0 
Hypothesis/Key Questions: The aim of this study is to prove that kenalog treatments are equal 
or superior to conventional cauterization with silver nitrate or use of soapcloth abrasion in reducing 
granulation tissue which forms following insertion of a feeding gastrostomy tube. We will perform 
measurements, use photographs and survery parents to answer this question. 
 
3.0 
Objectives: Evaluate the use of Kenalog vs Silver nitrate cauterization vs soapcloth abrasion 
around gastrostomy tube sites to reduce the development of granulation tissue. 
 
We will follow the patients via office visit at four and eight weeks after initiation of therapy. 
Measurements of the granulation tissue and photographs will be obtained pre treatment and at 
each post treatment visit. In addition parents will be asked to fill out a pre and post treatment 
survey regarding improvement in symptoms. We plan to enroll 120 patients total with the intention 
of having 40 participants in each group.  
 
 
4.0 
Selection of Patients 
4.1 
Inclusion Criteria (list): birth - 17 years of age, granulation tissue present around 
gastrostomy tube site for at least 1 week 
4.2 
Exclusion Criteria (list): allergy to any of the potential medications (silver nitrate or 
kenalog), Non-english speaking patients will be excluded due to inability to effectively 
communicate study details, risks and benefits. 
4.3 
Age Range: 0-17 years of age 
 
5.0 
Study Methodology: 
Prospective, randomized study utilizing children ages birth to 17 years, with granulation tissue 
present around their gastrostomy tube for at least one week. Patients will be randomized to one of 
the three treatment groups in equal numbers. Once the inclusion criteria are met, informed 
consent will be obtained from the parent and randomization will occur. Patients will be randomized 
to either Kenalog (0.5% ointment three times a day for three weeks) or cauterization with silver 
nitrate (three times a week for three weeks) or abrasion/washing with a soap washcloth (once 
daily for three weeks). At the end of the three week period, if granulation tissue is still present, the 
patients will undergo a rest period of one week, followed by another three week course. These 
children will be followed at four weeks and eight weeks via clinic visits. At the clinic visits, 
photographs and measurements will be obtained and parent surveys completed. 
 
 


 
6.0 
Study Methods 
6.1 
Source (location) of records or patients to be recruited:: Patients presenting to the 
Pediatric surgery service at Mott Children's Hospital either as an inpatient or outpatient, 
for treatment of granulation tissue at their gastrostomy site. The patients and their 
parents will be interviewed and the prospect of participating in this clinical trial will be 
discussed with them in a private consultation room where they will have opportunities to 
question the trial and protocol. 
 
6.2 
Describe how the charts to be reviewed will be identified: Patients meeting criteria will be 
identified through department specific queries from case schedules. 
 
6.3 
Describe who will identify charts to be reviewed:  The study team 
 
 
7.0 
Confidentiality of data   
7.1 
Describe how data (both paper and electronic) will be stored to safe-guard confidentiality 
(e.g. in a locked cabinet, password protected computer):  All electronic data will be kept 
on password protected, encrypted devices within the University of Michigan system 
which meet current security standards. Any paper records utilized during this review will 
be kept in a locked cabinet within the Pediatric Surgery research space and/or PI’s office. 
 
7.2 
Specify who will have access to harvested patient data:  Access will be given to 
personnel approved by the IRB.  
 
7.3 
Clarify long harvested patient data will be stored and how it will be destroyed when no 
longer needed:  We plan to keep this data for future use as this data will contribute to a 
future project. The data obtained will help to inform future projects and may be included 
as we further investigate this cohort/disease.  
 
8.0 
Consent Process (if applicable):  
Written comprehensive consent will be obtained in a face to face manner in the clinic or patient's 
hospital room at the initial encounter. Ages 0-6 will are requesting a waiver of assent. If the child is 
7-9 years of age or older and neurologically intact, informed assent will also be obtained from the 
child at that time via oral script. and children 10-17 will provide written assent, with children 10-14 
assenting on the written assent document and children 15-17 assenting on the consent document, 
which one parent provides parental permission on. 
 
For patients who are 7 years old or older and without neurological impairment and who have age 
appropriate neurodevelopment assent will be obtained. For children less than 7 years of age or 
with neurological impairment, a request for waiver of informed assent is requested, as this would 
not be feasible. The oral assent will be used and we will ask the child to "teach back" the 
information to ensure their understanding. 
 
9.0 
Risks and Benefits:  
9.1 
Overall Risks:  
Breach of confidentiality: Breach of confidentiality is not expected, though is always a risk 
despite measures the study team takes to mitigate the risk. 
 
 
 
Silver Nitrate:  
Very hazardous in case of skin contact (irritant), of ingestion. Hazardous in case of skin 
contact (permeator), of eye contact (irritant), of inhalation. Slightly hazardous in case of 
skin contact (corrosive). The amount of tissue damage depends on length of contact. The 
parents of the children will recieve instructions on administration of the drug and the 
duration of contact with the skin. Therefore, likelihood of causing further injury will be 
minimal. Eye contact can result in corneal damage or blindness. Skin contact can 
produce inflammation and blistering when a prolonged exposure is done. Education will 
be given to the parents regarding application and therapy. Inhalation of dust will produce 
irritation to gastro-intestinal or respiratory tract, characterized by burning, sneezing and 
coughing. Severe over-exposure can produce lung damage, choking, unconsciousness 
or death. Prolonged exposure mayresult in skin burns and ulcerations. Over-exposure by 
inhalation may cause respiratory irritation. There is no anticipated exposure of the 
respiratory system to the silver nitrate as this is being used only on the abdominal portion 


 
of the skin at the gastric tube site. 
 
 
 
Kenalog: 
 
 
Infrequent is a possible mild eye irritant 
Rapidly absorbed through skin, repeated exposure may cause skin dryness or cracking. 
May be harmful if absorbed through skin. The drug used in the concentration for the 
study has not been shown to be harmful to skin. Education regarding the potential side 
effects, application and skin care will be given to the parents. May cause damage to 
organs through prolonged or repeated exposure if swallowed. May cause damage to 
organs through prolonged or repeated exposure if inhaled. The drug is being used for 
topical application and will not be near the respiratory tract. Target Organs adrenal 
glands, bone, muscle, gastrointestinal tract, immune system, eyes, nervous system, skin, 
female reproductive organs, (embryo/fetus) Signs and Symptoms Chronic: muscle 
weakness, muscle pain, bone fractures, infection, oedema, headache, difficulty sleeping, 
vertigo, restlessness, euphoria, mental disturbance, depression, anxiety, mood changes, 
seizure disorders, nosebleeds, cough, fever, nausea, vomiting, anorexia, gastrointestinal 
disturbance, sore throat, dry mouth, taste disturbance, speech difficulty, congestion, 
redness and swelling of eyes, vision changes, facial swelling, skin thinning, acne, 
redness and swelling of skin, hives, bruising, superficial burning sensation, tingling. 
Medical conditions aggravated include: Diabetes, Liver disorders, infection, 
immunodeficiency, hypertension, myasthenia gravis, osteoporosis, peptic ulcer, psychotic 
disorders, colitis, kidney disorders. These are infrequently seen in children, and mostly 
seen in adults. 
 
Soapy washcloth: There are no foreseeable risks involved with using soapy washcloth 
as an arm in this study. 
 
  
9.2 
Benefits:  
This study may provide improved knowledge about the best way to treat granulation 
tissue in the future. In addition, the benefit of treatment of each patient's granulation 
tissue outweighs the risk of adverse effects of the treatment. 
 
10.0 
Statistical Considerations  
ANOVA and Chi square tests will be used to evaluate the differences between the three treatment 
groups. Actual measurements of the granulation site, blinded evaluation of the pictures and 
analysis of pre and post surveys will be incorporated into the data analysis.