Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue

NCT06681194 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY24070165
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing; Granulation Tissue

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (7)

• Cutometry

  From enrollment to 1 year after resolution of hypergranulation

• Scar color

  From enrollment to 1 year after resolution of hypergranulation

• Treatment satisfaction

  From enrollment to 1 year after resolution of hypergranulation

• Complications

  From enrollment to 1 year after resolution of hypergranulation

• Numeric Rating Scale (NRS)

  From enrollment to 1 year after resolution of hypergranulation

Study Arms (3)

Triamcinolone only

ACTIVE COMPARATOR

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

Silver nitrate only

ACTIVE COMPARATOR

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

Combination group

EXPERIMENTAL

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

Interventions

Silver Nitrate DRUG

See "Silver nitrate only" study arm

Silver nitrate only

triamcinolone DRUG

See "Triamcinolone only" study arm

Triamcinolone only

Silver nitrate + triamcinolone DRUG

See "Combination group" study arm

Combination group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francesco Egro: lead

Study Sites (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 24725728 BACKGROUND

• 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.

  PMID: 32839037 BACKGROUND

• 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.

  PMID: 22612258 BACKGROUND

• 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.

  PMID: 34687202 BACKGROUND

• 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.

  PMID: 38165005 BACKGROUND

MeSH Terms

Interventions

Silver Nitrate; Triamcinolone

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Francesco M Egro, MD, MSc, MRCS

  Department of Plastic Surgery, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco M Egro, MD

CONTACT

4048617944‬; egrofm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Plastic Surgery

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2025

Record last verified: 2024-11

Locations

US (1)