Silver Nitrate Vs. Triamcinolone for Treatment of Hypergranulation Tissue

Francesco Egro

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Granulation Tissue; Wound Healing

Treatments: Drug: triamcinolone; Drug: Silver Nitrate; Drug: Silver nitrate + triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06681194

STUDY24070165

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be 18 years or older.
• Patients must be admitted to the institution with non-infected, traumatic wounds exhibiting hypergranulation tissue.
• Patients must provide consent to participate in the study.
• Eligible wounds include superficial or partial-thickness wounds.
• Wounds will be categorized based on size and depth, with variations controlled for in the statistical analysis.

Exclusion criteria

• Patients with known allergies or contraindications to silver nitrate or triamcinolone.
• Patients with wounds that do not exhibit hypergranulation tissue.
• Patients with wounds not primarily due to traumatic injury (e.g., surgical wounds, pressure ulcers).
• Full-thickness, infected, or complex wounds will be excluded, as these may require different management strategies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

Triamcinolone only

Active Comparator group

Description:

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.

Treatment:

Drug: triamcinolone

Silver nitrate only

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Nitrate

Combination group

Experimental group

Description:

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.

Treatment:

Drug: Silver nitrate + triamcinolone