Comparison of Patient Outcomes With Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Erythema Assessment scale
研究概览
简要总结
Purpose - This exploratory, split-wound study aims to evaluate the potential difference in skin reactions to two different types of sutures, dyed and undyed, used to close wounds after surgery. The study will assess whether dyed sutures to elicit increased tissue reactivity like redness, itching, and scarring and whether undyed sutures may be more optimal for wound healing and cosmetic response. Enrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.
Primary Objective - The primary objective is to assess the response of wounds closed with both dyed and undyed sutures after cutaneous surgery to determine if there is a difference in wound healing and tissue reactivity with one compared to the other.
Enrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 who are scheduled for a standard of care surgical excision
排除标准
- •Patients who are unable to give informed consent
研究组 & 干预措施
Dyed Sutures
Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Dyed Sutures.
干预措施: Polyglactin 910 (Dyed) (Device)
Undyed Sutures
Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Undyed Sutures.
干预措施: Polyglactin 910 (Undyed) (Device)
结局指标
主要结局
Clinical Erythema Assessment scale
时间窗: 3 months post-procedure
Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.
Presence of Hypertrophic Scarring
时间窗: 3 months post-procedure
Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.
Presence of Suture Extrusion
时间窗: 3 Months post-procedure
Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.
Presence of Dehiscence
时间窗: 3 months post-procedure
Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.
Presence of Surgical Site Infection
时间窗: 3 Months post-procedure
Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.
Presence of Hyperpigmentation
时间窗: 3 months post-procedure
Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.
Presence of Edema
时间窗: 3 months post-procedure
Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Failure to Epithelialize
时间窗: 3 months post-procedure
Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.
Presence of Suture Granuloma
时间窗: 3 months post-procedure
Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.
Presence of Contact Dermatitis
时间窗: 3 months post-procedure
Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.
Patient-Rated Pruritus
时间窗: 3 months post-procedure
Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
Patient-Rated Pain/Tenderness
时间窗: 3 months post-procedure
Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
Presence of Wound Induration
时间窗: 3 months post-procedure
Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Presence of Exudate
时间窗: 3 months post-procedure
Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.
Clinical Erythema Assessment scale
时间窗: 2 weeks post-procedure
Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.
Clinical Erythema Assessment scale
时间窗: 4 weeks post-procedure
Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.
Presence of Hypertrophic Scarring
时间窗: 2 weeks post-procedure
Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.
Presence of Hypertrophic Scarring
时间窗: 4 weeks post-procedure
Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.
Presence of Suture Extrusion
时间窗: 2 weeks post-procedure
Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.
Presence of Suture Extrusion
时间窗: 4 weeks post-procedure
Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.
Presence of Surgical Site Infection
时间窗: 2 weeks post-procedure
Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.
Presence of Surgical Site Infection
时间窗: 4 weeks post-procedure
Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.
Presence of Edema
时间窗: 2 weeks post-procedure
Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Presence of Edema
时间窗: 4 weeks post-procedure
Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Presence of Wound Induration
时间窗: 2 weeks post-procedure
Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Presence of Wound Induration
时间窗: 4 weeks post-procedure
Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.
Presence of Hyperpigmentation
时间窗: 2 weeks post-procedure
Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.
Presence of Hyperpigmentation
时间窗: 4 weeks post-procedure
Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.
Presence of Exudate
时间窗: 2 weeks post-procedure
Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.
Presence of Exudate
时间窗: 4 weeks post-procedure
Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.
Presence of Dehiscence
时间窗: 2 weeks post-procedure
Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.
Presence of Dehiscence
时间窗: 4 weeks post-procedure
Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.
Failure to Epithelialize
时间窗: 2 weeks post-procedure
Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.
Failure to Epithelialize
时间窗: 4 weeks post-procedure
Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.
Presence of Suture Granuloma
时间窗: 2 weeks post-procedure
Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.
Presence of Suture Granuloma
时间窗: 4 weeks post-procedure
Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.
Presence of Contact Dermatitis
时间窗: 2 weeks post-procedure
Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.
Presence of Contact Dermatitis
时间窗: 4 weeks post-procedure
Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.
Patient-Rated Pruritus
时间窗: 2 weeks post-procedure
Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
Patient-Rated Pruritus
时间窗: 4 weeks post-procedure
Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
Patient-Rated Pain/Tenderness
时间窗: 2 weeks post-procedure
Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
Patient-Rated Pain/Tenderness
时间窗: 4 weeks post-procedure
Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.
次要结局
未报告次要终点
研究者
Sarah Campbell
Assistant Professor
West Virginia University