Silver Nitrate vs. Triamcinolone for Treatment of Hypergranulation Tissue

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancesco Egro

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Silver Nitrate

    Drug

    See "Silver nitrate only" study arm

  • triamcinolone

    Drug

    See "Triamcinolone only" study arm

  • Silver nitrate + triamcinolone

    Drug

    See "Combination group" study arm

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Triamcinolone onlyActive comparator 1 intervention
Group B: Silver nitrate onlyActive comparator 1 intervention
Group C: Combination groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation
2

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation
3

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation
4

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation

Secondary outcomes

1

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation
2

Scar color

Using colorimetry, this outcome measures changes in skin/scar color, providing insights into the effects of the treatments on skin appearance.

Time frame
From enrollment to 1 year after resolution of hypergranulation
3

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation
4

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.

Time frame
From enrollment to 1 year after resolution of hypergranulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Francesco Egro

Lead sponsor

University of Pittsburgh

Sponsor institution

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