Wound Healing, Granulation Tissue
Conditions
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.
Interventions
DRUGSilver Nitrate
See Silver nitrate only study arm
DRUGtriamcinolone
See Triamcinolone only study arm
DRUGSilver nitrate + triamcinolone
See Combination group study arm
Sponsors
Francesco Egro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Hypergranulation Tissue Size | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Vancouver Scar Scale (VSS) | From enrollment to 1 year after resolution of hypergranulation | 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 to healing | From enrollment to 1 year after resolution of hypergranulation | This outcome records the duration required for the wound to reach significant improvement or closure, helping to assess the treatment's efficiency. |
| Patient and Observer Scar Assessment Scale (POSAS) | From enrollment to 1 year after resolution of hypergranulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Cutometry | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Elastometry | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Durometry | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Scar color | From enrollment to 1 year after resolution of hypergranulation | Using colorimetry, this outcome measures changes in skin/scar color, providing insights into the effects of the treatments on skin appearance. |
| Treatment satisfaction | From enrollment to 1 year after resolution of hypergranulation | 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. |
| Complications | From enrollment to 1 year after resolution of hypergranulation | 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. |
Countries
United States
Contacts
Primary ContactFrancesco M Egro, MD
Outcome results
None listed