Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Francesco Egro
- Study ID
- NCT06681194
- Phase
- PHASE2/PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Granulation Tissue
- Wound Healing
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Silver Nitrate — DRUGSee "Silver nitrate only" study arm
- triamcinolone — DRUGSee "Triamcinolone only" study arm
- Silver nitrate + triamcinolone — DRUGSee "Combination group" study arm
Study Details
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.
Key Dates
- Start date
- Jun 1, 2025
- Status verified
- Nov 2024
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 270 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Triamcinolone onlyPatients 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.
- Active Comparator: Silver nitrate onlyDuring 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.
- Experimental: Combination groupThe 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.
Primary Outcome Measure
Reduction in Hypergranulation Tissue Size [ Time Frame: From enrollment to 1 year after resolution of hypergranulation ]
Central Contacts
- Francesco M Egro, MD4048617944
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Mercy Hospital | Pittsburgh | Pennsylvania | 15213 | Francesco M Egro, MD, MSc, MRCS (PRINCIPAL_INVESTIGATOR) Jenny A Ziembicki, MD (SUB_INVESTIGATOR) Alain C Corcos, MD, FACS (SUB_INVESTIGATOR) Garth A Elias, MD (SUB_INVESTIGATOR) Justine S Kim, MD (SUB_INVESTIGATOR) Guy M Stofman, MD (SUB_INVESTIGATOR) |
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