A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Scored cosmetic appearance by blinded physician
研究概览
简要总结
The study aims to compare outcomes in patient comfort, cosmetic appearance, and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic.
详细描述
I. Purpose, Background and Rationale A. Aim and Hypotheses
-
Standard of care for epidermal wound closure in dermatology is generally considered to be sutures, however many specialties utilize staples due to their increased speed of closure. In particular, high tension wound areas within dermatology may be more suitable for closure with staples given their higher tensile strength when compared to sutures.
-
The hypothesis is that for high tension areas:
-
Staples will provide improved cosmetic outcomes compared with sutures along with a reduction in closure times.
-
Patient comfort during the placement of staples, as well as the healing and removal process, will be no different than what patients with sutures experience.
B. Background and Significance
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
- Single (Outcomes Assessor)
盲法说明
Physician evaluating scars post closure will be blinded
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
- •18 and over
- •Willing to return to KU for follow up clinic visits on at least 2 occasions
- •Lesion location on high tension area as defined by: back, shoulder, scapula, elbow, scalp
- •Incisions between the lengths of 3cm to 12 cm
- •Skin pathology as defined by BCC, SCC, Melanoma
- •No known history of keloid or excessive scar formation
- •No known contraindication or skin sensitivity to suture or staple material
- •No contraindication to lidocaine with epinephrine
排除标准
- •<18 years old
- •Non english speaking
- •Needs surrogate decision maker
研究组 & 干预措施
Suture group
1/2 of the total number of patients will be randomized into the suture group (excision wound will be closed with suture), the intervention is the method of closure (sutures or staples)
干预措施: Wound Closure with sutures vs staples (Other)
Staples group
1/2 of the total number of patients will be randomized into the staples group (excision wound will be closed with staples), the intervention is the method of closure (sutures or staples)
干预措施: Wound Closure with sutures vs staples (Other)
结局指标
主要结局
Scored cosmetic appearance by blinded physician
时间窗: 6 months post procedure
A blinded physician will grade the cosmetic appearance of the scar using a visual analog scale and Vancouver scar scale
Scored cosmetic appearance by patient
时间窗: 6 months post procedure
The patient will grade the cosmetic appearance of the scar using a visual analog scale
Patient self reported comfort with placement of either sutures or staples
时间窗: at time of surgery
Patients will fill out a survey after either suture or staple placement to assess how comfortable placement of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.
Patient self reported comfort with removal of either sutures or staples
时间窗: 2 weeks after placement
Patients will fill out a survey after either suture or staple removal to assess how comfortable the removal of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.
Scored cosmetic appearance by blinded physician
时间窗: 2 weeks post procedure
A blinded physician will grade the cosmetic appearance of the scar using a visual analog scale and Vancouver scar scale
Scored cosmetic appearance by patient
时间窗: 2 weeks post procedure
The patient will grade the cosmetic appearance of the scar using a visual analog scale
次要结局
- Number and types of complications reported(procedure until 6 month follow up)