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

270 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Silver Nitrate vs. Triamcinolone for Proud Flesh?

Triamcinolone acetonide, a component of the treatment, is known for its strong anti-inflammatory effects and long-lasting action, which can be beneficial in treating skin conditions. This suggests it may help reduce inflammation and promote healing in proud flesh. ^{1 2 3 4 5}

Is triamcinolone safe for use in humans?

Triamcinolone, used in various forms like Kenalog, has been associated with some side effects such as weight gain, menstrual disturbances, increased blood pressure, and skin reactions. These side effects were observed in a small percentage of patients, indicating that while generally safe, it can cause adverse effects in some individuals. ^{1 2 5 6 7}

What makes the drug triamcinolone unique for treating proud flesh?

Triamcinolone is unique because it can be administered intramuscularly, providing long-lasting effects with a seemingly low dose compared to other corticosteroids, which may be beneficial for conditions like proud flesh where prolonged anti-inflammatory action is needed. ^{1 2 6 7 8}

What is the purpose of this trial?

This randomized controlled trial aims to compare the efficacy of silver nitrate, triamcinolone, and a successive use of both treatments in managing hypergranulation tissue in traumatic wounds. Conducted over a four-year period at UPMC Mercy, the study will involve patients presenting with hypergranulation tissue. Participants will be randomly assigned to receive either topical silver nitrate, topical triamcinolone, or a combination of the two in succession. The study will assess treatment outcomes based on the reduction or resolution of hypergranulation tissue, with the goal of identifying the most effective therapeutic approach. This research will provide valuable insights into optimizing treatment strategies for hypergranulation tissue in traumatic wounds.

Research Team

Francesco M Egro, MD, MSc, MRCS

Principal Investigator

Department of Plastic Surgery, University of Pittsburgh Medical Center

Eligibility Criteria

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.

I am not allergic to silver nitrate or triamcinolone.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Enigma of Intramuscular Triamcinolone Acetonide (Kenalog®) Efficacy. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Comparative evaluation of the potencies of external corticoids with various test methods]. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Topical formulations of fluocinolone acetonide. Are creams, gels and ointments bioequivalent and does dilution affect activity? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

7. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]