Silver Nitrate vs. Triamcinolone for Proud Flesh

Overseen By Francesco M Egro, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Francesco Egro

Disqualifiers: Allergies, Non-traumatic wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, silver nitrate and triamcinolone (a corticosteroid), for managing proud flesh (extra tissue) in wounds from injuries. Researchers aim to determine which treatment is most effective or if a combination of both yields better results. Participants will be divided into three groups: one using silver nitrate, another using triamcinolone, and a third using both in sequence. The trial seeks individuals with non-infected, superficial, or partial-thickness wounds showing extra tissue growth. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both silver nitrate and triamcinolone are generally safe for treating overgrown tissue, though some side effects may occur.

For silver nitrate, studies have found it can occasionally cause mild skin issues, such as redness or a slight burn, particularly if it contacts healthy skin. These effects are rare and typically heal on their own. Careful application can help prevent these issues.

Triamcinolone may lead to skin thinning, dryness, or local irritation like itching or burning, especially with long-term use. As a type of steroid, triamcinolone can sometimes cause additional side effects, such as skin thinning or weakening.

When used together, these treatments aim to enhance effectiveness by combining their effects. Silver nitrate helps remove excess tissue, while triamcinolone reduces swelling. However, users should remain vigilant for the side effects mentioned above.

Overall, both treatments have been used successfully in other conditions, indicating they are well-tolerated when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for proud flesh (hypergranulation tissue) because they offer new ways to tackle this stubborn condition. Silver nitrate works by cauterizing the tissue and has antimicrobial properties, making it different from standard treatments like corticosteroids, which mostly focus on reducing inflammation. Triamcinolone, a type of corticosteroid, is already used to reduce inflammation effectively, but combining it with silver nitrate could enhance healing by attacking the problem from multiple angles. The experimental approach of using silver nitrate initially, followed by triamcinolone, aims to harness both the antimicrobial benefits of silver nitrate and the anti-inflammatory effects of triamcinolone, potentially speeding up recovery and offering a comprehensive treatment strategy.

What evidence suggests that this trial's treatments could be effective for hypergranulation tissue?

This trial will compare the effectiveness of triamcinolone, silver nitrate, and their combination for treating overgrown tissue in wounds. Studies have shown that triamcinolone effectively treats overgrown tissue, with some studies reporting up to 100% complete healing and most patients noticing improvements within 2 to 4 weeks. Silver nitrate has also been used, but evidence for its effectiveness is less strong, particularly for issues like ingrown toenails. However, it can help reduce the size of some overgrown tissues. The combination group in this trial will receive both treatments, potentially benefiting from silver nitrate's initial tissue-reducing effect and triamcinolone's ability to reduce inflammation. ^{1 2 6 7 8}

Who Is on the Research Team?

Francesco M Egro, MD, MSc, MRCS

Principal Investigator

Department of Plastic Surgery, University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with hypergranulation tissue from traumatic wounds. Participants must be treated at UPMC Mercy and willing to use either silver nitrate, triamcinolone, or both in succession. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

My wound is on the surface or partway through the skin.

Patients must provide consent to participate in the study

I have a non-infected wound with excessive tissue growth and am admitted to the hospital.

Exclusion Criteria

My wounds are not from an injury but may be from surgery or pressure sores.

My wounds are not deep, infected, or complicated.

My wounds do not have excessive tissue growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical silver nitrate, topical triamcinolone, or a combination of both treatments for managing hypergranulation tissue.

8 weeks

Inpatient stay followed by outpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including photographic documentation and various scar and skin quality measures.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Silver Nitrate
• Silver Nitrate + Triamcinolone
• Triamcinolone

Trial Overview The study compares three treatments: topical silver nitrate alone, topical triamcinolone alone, and a combination of both used one after the other. It's a randomized controlled trial aiming to find out which treatment best reduces or resolves hypergranulation tissue.

How Is the Trial Designed?

Group I: Combination group Experimental Treatment 1 Intervention

The combination group receives treatment with silver nitrate sticks applied directly to the hypergranulation tissue during their inpatient stay. Upon discharge, patients switch from silver nitrate to triamcinolone 0.5%, which they apply once daily to affected areas in the outpatient setting. This treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout. This combination approach aims to leverage both the initial cauterizing and antimicrobial effects of silver nitrate with the subsequent anti-inflammatory benefits of triamcinolone.

Group II: Triamcinolone only Active Control 1 Intervention

Patients in the triamcinolone group receive triamcinolone 0.5% applied topically to the hypergranulation tissue during their inpatient stay. Upon discharge, patients continue with the same triamcinolone 0.5% treatment, applying it once daily to affected areas in the outpatient setting. Treatment continues until either resolution of hypergranulation tissue (typically within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Standard wound care practices including appropriate dressings and antibiotics are maintained throughout the treatment period.

Group III: Silver nitrate only Active Control 1 Intervention

During the inpatient phase, patients in this group receive treatment with silver nitrate sticks applied directly to the hypergranulation tissue. Upon discharge, patients transition to using 0.5% silver nitrate solution for outpatient care, which is applied once daily to the affected areas. The switch to solution form for outpatient treatment is made because it is less painful and easier to apply, particularly on difficult-to-access areas of the body. Treatment continues until either resolution of hypergranulation tissue (typically occurring within 3-4 weeks) or until 8 weeks have passed without resolution, at which point the patient is considered a treatment failure if open areas persist. Throughout the treatment period, standard wound care practices including appropriate dressings and antibiotics are maintained.

Who Is Running the Clinical Trial?

Francesco Egro

Lead Sponsor

Trials

2

Recruited

320+

Published Research Related to This Trial

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

The study tested the common belief that higher concentrations of topical corticosteroids lead to greater biological activity using a vasoconstriction assay, which is linked to clinical effectiveness.

Results showed that for many brand-name formulations, higher concentrations do not always correlate with increased efficacy, indicating that the effectiveness of topical corticosteroids can vary significantly even among different concentrations of the same medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The same glucocorticoid in brand-name products. Does increasing the concentration result in greater topical biologic activity? Stoughton, RB., Wullich, K.[2010]

Intramuscular triamcinolone acetonide (Kenalog®) has a unique ability to provide long-lasting anti-inflammatory effects, making it distinct from other corticosteroids, which may be due to its low solubility in blood and slow absorption rate.

The efficacy of triamcinolone acetonide at low doses for treating dermatologic diseases suggests that its mechanism of action involves complex binding properties and metabolic pathways that are not yet fully understood, indicating potential for further research in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enigma of Intramuscular Triamcinolone Acetonide (Kenalog®) Efficacy. Shahinfar, S., Maibach, H.[2023]

Amcinonide cream was classified as a very strong corticosteroid, while prednicarbate cream was found to be moderately strong, based on a series of tests including the vasoconstriction test conducted on healthy young individuals.

The vasoconstriction test proved to be an effective screening method for determining the potency of corticosteroid preparations, with results largely consistent across various other tests, although clinical evaluations are recommended for further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative evaluation of the potencies of external corticoids with various test methods]. Koch, EM., Ott, R.[2016]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a study involving healthy volunteers, the vasoconstrictor activity of three formulations of fluocinolone acetonide (gel, cream, and ointment) was tested, revealing that the cream was the most potent, followed by the gel and ointment.

Diluting the cream formulation up to 1 in 10 did not significantly reduce its potency, suggesting that the current potency classifications in the British National Formulary for these formulations may need to be updated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical formulations of fluocinolone acetonide. Are creams, gels and ointments bioequivalent and does dilution affect activity? Gao, HY., Li Wan Po, A.[2019]

A 24-year-old woman experienced an immediate hypersensitivity reaction to intralesional triamcinolone acetonide after 10 years of successful treatment for keloid scars, highlighting that such reactions, while uncommon, can occur even after multiple prior injections without issues.

Allergy testing confirmed a positive reaction specifically to triamcinolone acetonide, indicating that IgE-mediated hypersensitivity should be considered in patients receiving repeated injections of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. Laisuan, W., Wongsa, C., Dchapaphapeaktak, N., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34687202/

Hypertrophic Granulation Wounds Treated With Silver ... Median length and width were decreased by 5 mm with silver nitrate cautery treatment, and by 14 mm with 1% hydrocortisone treatment (P < .05).

2. seslhd.health.nsw.gov.au seslhd.health.nsw.gov.au/sites/default/files/documents/SESLHDPR%20400%20-%20Wound%20Management%20of%20Hypergranulation%20Tissue_0.pdf

SESLHD PROCEDURE COVER SHEET • Moisten the tip of the silver nitrate stick with sterile water. • Touch the silver nitrate stick onto the hypergranulation tissue for 5 seconds6. It will.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4986970/

Treatment of hypergranulation tissue in burn wounds with ... All patients showed an improvement in the treated areas with a complete regression of hypergranulation tissue and closure of the burn wounds. No ...

4. researchgate.net researchgate.net/publication/374583872_The_use_of_silver_nitrate_AgNO3_as_a_caustic_agent_for_the_treatment_of_hypergranulation_tissue_affecting_ingrown_toenails_A_scoping_review

(PDF) The use of silver nitrate (AgNO3) as a caustic agent ... This review found very little evidence to support the use of silver nitrate for treating the hypergranulation tissue affecting ingrown toenails.

5. internationalfootankle.org internationalfootankle.org/journal/index.php/JIFAF/article/download/70/60/191

The use of silver nitrate (AgNO3) as a caustic agent for the ... In conclusion, this review found very little evidence to support the use of silver nitrate for treating the hypergranulation tissue affecting ingrown toenails.

6. thewoundpros.com thewoundpros.com/post/silver-nitrate-what-you-need-to-know

Silver Nitrate: What You Need To Know Tissue Damage: Prolonged or excessive exposure to silver nitrate can lead to chemical burns or irritating the surrounding healthy tissue. Care should be taken ...

7. childrenswi.org childrenswi.org/teaching-sheet/trach-vent/silver-nitrate-for-granulation-tissue

Silver Nitrate for Granulation Tissue Sometimes silver nitrate may cause a mild skin injury. This is rare. The skin can be burned and red. It will heal. Do not let the medicine touch any other skin ...

8. aithor.com aithor.com/essay-examples/hypergranulation-tissue-causes-and-treatment

Hypergranulation Tissue: Causes and Treatment Silver nitrate is the treatment of choice to chemically debulk hypergranulation tissue. Silver nitrate is widely used for wound debridement ...