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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
See "Silver nitrate only" study arm
See "Triamcinolone only" study arm
See "Combination group" study arm
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States
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
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
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
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
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
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
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
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 1 year after resolution of hypergranulation