Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color: A Prospective, Randomized Split-wound Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- POSAS
研究概览
简要总结
The present study assesses if dissolvable (fast gut) or non-dissolvable (polypropylene) epidermal sutures produce better cosmetic results in terms of dyspigmentation and scarring in patients of skin of color. Through a split-wound study design, patients undergoing standard elliptical excisions at least 3 cm in length will receive each suture type. Measurements of dyspigmentation and scarring will be made at 7 days (for the head and neck), 10 days (for the trunk and extremities), and 3 months for all locations.
详细描述
Subjects who consent to the study will have the following information recorded on the date of surgery: age, sex, indication for surgery, surgical site, scar length, size and type of buried intradermal suture, experience of surgeon (attending, fellow or resident), and New Immigration Scale (NIS) skin color. Basic patient medical data pertinent to wound healing/scar formation will be extracted from the medical record including history of hypertrophic scar/keloids, smoking, diabetes mellitus, and immunosuppression.
The subjects will undergo elliptical excision per standard of care. A single polyglactin 910 suture buried intradermal suture will be placed at the center of the wound. If additional buried intradermal sutures are needed, they will be placed equidistant from the center of the wound such that each side has an equivalent number of intradermal sutures. 5-0 polyglactin 910 will be used for wounds on the head and neck and 3-0 or 4-0 polyglactin 910 will be used for wounds on the trunk and extremities.
Following placement of the intradermal sutures, the subject's wound will be demarcated into halves, labeled either "A" or "B." "A" refers to the left or the superior side, and "B" refers to the right or inferior side. Prior to the study commencement, "A=fast gut" will be written on 17 index cards and "B=fast gut" will be written on 17 index cards. The index cards will be sealed in individual envelopes, shuffled to randomize, and stored securely with the study materials. At the time of surgery, the surgeon will randomly select an envelope which indicates which side will receive which suture type (either 5-0 fast absorbing gut or 5-0 polypropylene). This size of epidermal sutures will be used regardless of site of wound. The intervention will be applied sequentially with side A always being closed first. A simple running suture will be used on each half. The surgeon will aim to keep suture technique including spacing and distance from wound edge identical.
Following the procedure, a standard dressing will be applied and wound care will be discussed. Patients will be seen, as is routinely performed clinically, for suture removal for the polypropylene side in 7 days if the closure was on the head and neck and 10 days if the closure was on the trunk or extremities. Any residual component of fast gut suture that has not yet dissolved will be removed by the medical assistant or nurse so that the physician observer is blinded to which sutures were placed on which side. The following information will be collected at this suture removal visit:
- Photo of the scar
- Patients will perform the patient portion of the POSAS (Patient and Observer Scar Assessment Scale), a validated scale of scar cosmesis.
- A co-investigator not present at the time of the surgical procedure will perform the physician portion of the POSAS
- Scar width will be measured 1 cm from midline on each side of the wound. Measurements will be recorded in 0.5 mm increments.
- Pain incurred with suture removal will be measured via a 10 point Visual Analog Scale immediately after sutures are removed, with 1 representing no pain and 10, the worst pain imaginable.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Sutures will be removed in their entirety before scar assessment by a co-investigator such that the outcomes assessor is blinded to which suture was used on which side of the scar.
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
- •Age 18 years or older
- •Undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater. Benign and malignant lesions will be included, including those that have undergone Mohs micrographic surgery prior to standard linear closure. All body sites will be included.
- •Able to give informed consent
- •Able to return for 3 month follow up
- •New Immigration Scale (NIS) skin color 4 or greater - The NIS is an 11 point scale, ranging from zero to 10, with zero representing albinism and 10 representing the darkest possible skin.
排除标准
- •High-tension closures not amenable to 5-0 simple running epidermal sutures
- •Known allergy to suture material
研究组 & 干预措施
A= left/superior half of wound
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
干预措施: 5-0 Polypropylene epidermal suture (Device)
A= left/superior half of wound
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
干预措施: 5-0 Fast gut epidermal suture (Device)
B= right/inferior half of wound
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
干预措施: 5-0 Polypropylene epidermal suture (Device)
B= right/inferior half of wound
Patients with skin of color undergoing dermatologic surgery with planned standard elliptical excision with wound length of 3 cm or greater
干预措施: 5-0 Fast gut epidermal suture (Device)
结局指标
主要结局
POSAS
时间窗: 3 months from procedure
Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.
Skin hyperpigmentation index
时间窗: 3 months from procedure
1-4 scale, higher value indicates worse outcomes (greater dyspigmentation), lower values represent better outcomes
POSAS
时间窗: Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities
Patient and Observer Scar Assessment Scale (POSAS) outcome (6-60 scale). 6 subscales (which assess scar pain, itch, color, stiffness, thickness, and irregularity) comprise the POSAS measure and each are measured 1-10. Subscales will be summed to get a total score out of 60. Higher values represent worse outcomes.
次要结局
- Complications(3 months from procedure)
- Scar width(3 months from procedure)
- Scar width(Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities)
- Complications(Suture removal date which is 7 days from the procedure if the excision is on the head or neck and 10 days from the procedure if the excision is on the trunk or extremities)
研究者
Melissa Pugliano-Mauro
Assistant Professor
University of Pittsburgh
