A Comparative Study of Silver Nitrate, Triamcinolone, and Their Successive Combined Use on Hypergranulation Tissue in Traumatic Wounds: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Reduction in Hypergranulation Tissue Size
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: triamcinolone (Drug)
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.
干预措施: Silver Nitrate (Drug)
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.
干预措施: Silver nitrate + triamcinolone (Drug)
结局指标
主要结局
Reduction in Hypergranulation Tissue Size
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Durometry(From enrollment to 1 year after resolution of hypergranulation)
- Elastometry(From enrollment to 1 year after resolution of hypergranulation)
研究者
Francesco Egro
Associate Professor, Plastic Surgery
University of Pittsburgh