Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue

A Comparative Study of Silver Nitrate, Triamcinolone, and Their Successive Combined Use on Hypergranulation Tissue in Traumatic Wounds: A Randomized Control 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.

Study Overview

• Status: Withdrawn
• Conditions: Wound Healing; Granulation Tissue
• Intervention / Treatment: Drug: triamcinolone; Drug: Silver Nitrate; Drug: Silver nitrate + triamcinolone

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triamcinolone only; 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.	Drug: triamcinolone; See "Triamcinolone only" study arm
Active Comparator: Silver nitrate only; 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.	Drug: Silver Nitrate; See "Silver nitrate only" study arm
Experimental: Combination group; 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.	Drug: Silver nitrate + triamcinolone; See "Combination group" study arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vancouver Scar Scale (VSS)	The scale measures scar characteristics based on color, pliability, height, and area. The VSS consists of three components: 1) Color (0-3), 2) Pliability (0-3), and 3) Height (0-3), with a total area score calculated based on the size of the scar. The overall score ranges from 0 to 13, where 0 indicates normal skin and higher scores represent worse scar quality. Specifically, higher values in color, pliability, and height indicate more severe scarring, while the area score provides an additional measure of size. The individual scores for color, pliability, and height can be summed to compute the total score, with the area score added to provide a comprehensive assessment of scar severity.	From enrollment to 1 year after resolution of hypergranulation
Time to healing	This outcome records the duration required for the wound to reach significant improvement or closure, helping to assess the treatment's efficiency.	From enrollment to 1 year after resolution of hypergranulation
Patient and Observer Scar Assessment Scale (POSAS)	The scale measures the quality of scars from both patient and observer perspectives. The scale includes two main components: the Patient Scale and the Observer Scale. Each component consists of 6 items rated on a scale from 1 to 10, where 1 represents "no scar" and 10 represents "the worst scar imaginable," allowing for a total score range of 6 to 60 for each scale. Higher scores indicate worse outcomes, reflecting greater scar severity and patient distress. To compute a total score, the subscale scores can be summed, providing an overall assessment of scar quality from both perspectives.	From enrollment to 1 year after resolution of hypergranulation
Reduction in Hypergranulation Tissue Size	The investigators will report the changes in hypergranulation tissue size, assessing the change from baseline to follow-up. This will include measuring the hypergranulation size and tracking the percentage reduction over time for participants, with photographic documentation taken at baseline, resolution, and up to one year post-resolution to visually compare size changes. The outcome will evaluate the efficacy of each treatment through clinical observation and standardized wound assessment tools, ensuring that volume is documented as a distinct entry to comply with reporting requirements.	From enrollment to 1 year after resolution of hypergranulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutometry	This outcome assesses the structural integrity of the skin post-treatment, measured using a cutometer. The cutometer evaluates skin firmness and elasticity by applying a vacuum to the skin and measuring the degree of deformation. This assessment provides quantitative data on how well the skin maintains its structure after hypergranulation treatment, allowing for a comparison of improvements over time.	From enrollment to 1 year after resolution of hypergranulation
Scar color	Using colorimetry, this outcome measures changes in skin/scar color, providing insights into the effects of the treatments on skin appearance.	From enrollment to 1 year after resolution of hypergranulation
Treatment satisfaction	The satisfaction scale for evaluating hypergranulation treatment uses a numeric scale from 1 to 10, where respondents indicate their level of satisfaction with the treatment. A score of 1 represents "Very Dissatisfied," indicating complete unhappiness with the treatment, while a score of 10 signifies "Completely Satisfied," reflecting total contentment with the treatment and its outcomes. This scale allows patients to provide a clear, quantifiable assessment of their treatment experience, which can inform improvements in care and patient outcomes.	From enrollment to 1 year after resolution of hypergranulation
Numeric Rating Scale (NRS)	The Numeric Rating Scale (NRS) for pain is a subjective measure used to assess a patient's level of pain on a scale from 0 to 10. Patients are asked to rate their pain by selecting a number that best represents their current pain level. This scale allows healthcare providers to quickly gauge the severity of pain and monitor changes over time, facilitating appropriate pain management strategies.	From enrollment to 1 year after resolution of hypergranulation
Complications	This outcome will report the number of participants experiencing any complications related to hypergranulation treatment, including infection, skin sloughing, and delayed wound healing. By tracking these complications, the investigators will evaluate the safety profile of each treatment method. Specifically, the investigators will document the incidence of each complication, providing a clear metric for assessing the overall safety and tolerability of the treatments used. This information will be crucial for understanding the risks associated with each approach and guiding future treatment decisions.	From enrollment to 1 year after resolution of hypergranulation
Durometry	The mechanical properties of the skin will be evaluated using a durometer, which measures the hardness of the skin. This measurement reflects the skin's resilience and texture following treatment. By documenting changes in skin hardness, the investigators can gain insights into how the treatment affects the skin's overall quality and tactile properties, contributing to a comprehensive understanding of treatment efficacy.	From enrollment to 1 year after resolution of hypergranulation
Elastometry	Skin elasticity will be assessed using an elastometer, which quantifies the skin's ability to stretch and return to its original shape. This outcome reflects improvements in the skin's mechanical properties and overall health post-treatment. By analyzing the elasticity of the skin, the investigators can better understand the treatment's impact on skin recovery and resilience, providing valuable information for patient care and outcomes.	From enrollment to 1 year after resolution of hypergranulation

Collaborators and Investigators

• Sponsor: Francesco Egro
• Investigators: Principal Investigator: Francesco M Egro, MD, MSc, MRCS, Department of Plastic Surgery, University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• McShane DB, Bellet JS. Treatment of hypergranulation tissue with high potency topical corticosteroids in children. Pediatr Dermatol. 2012 Sep-Oct;29(5):675-8. doi: 10.1111/j.1525-1470.2012.01724.x. Epub 2012 May 21.
• Moio M, Mataro I, Accardo G, Canta L, Schonauer F. Treatment of hypergranulation tissue with intralesional injection of corticosteroids: preliminary results. J Plast Reconstr Aesthet Surg. 2014 Jun;67(6):e167-8. doi: 10.1016/j.bjps.2014.03.017. Epub 2014 Mar 26. No abstract available.
• Baumann ME, DeBruler DM, Blackstone BN, Coffey RA, Boyce ST, Supp DM, Bailey JK, Powell HM. Direct comparison of reproducibility and reliability in quantitative assessments of burn scar properties. Burns. 2021 Mar;47(2):466-478. doi: 10.1016/j.burns.2020.07.018. Epub 2020 Aug 2.
• Linneman PK, Litt J. Hypertrophic Granulation Wounds Treated With Silver Nitrate Sticks or With Topical Steroid: Rate of Wound Closure. J Burn Care Res. 2022 Mar 23;43(2):403-407. doi: 10.1093/jbcr/irab196.
• Maynell KB, West W 3rd, Marek J, Wright B, Bodnar M, Le NK, Whalen K, Taylor L, Troy J, Smith D Jr, Laun J. Utilization of Topical Polysporin and Triamcinolone for the Treatment of Hypergranulation Tissue. J Burn Care Res. 2024 May 6;45(3):669-674. doi: 10.1093/jbcr/irad205.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): February 2, 2026
• Study Completion (Actual): February 3, 2026

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Inorganic Chemicals; Nitrogen Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Nitric Acid; Nitrates; Silver Compounds; Triamcinolone; Silver Nitrate
• Other Study ID Numbers: STUDY24070165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators may provide deidentified patient information journals if requested; however, the investigators are currently undecided about the likelihood of such requests. While the investigators recognize the importance of data sharing for advancing research, the investigators must consider patient confidentiality and ethical considerations when determining the approach.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No