跳至主要内容
临床试验/NCT05267002
NCT05267002Unknown不适用

One Week Versus Two Week Removal of Nylon Cutaneous Sutures for Linear Layered Closures on the Face: a Randomized Evaluator-blinded Prospective Split-scar Trial

DermSurgery Associates1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
Scar Cosmesis Assessment and Rating scale (SCAR) score

研究概览

简要总结

Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks.

There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. This has not been formally studied. It is possible the outcomes are the same between both groups, or that one has a better cosmetic outcome than the other.

Your skin cancer will be removed as usual. After this, your wound will be sutured in the usual fashion, except the top sutures will be divided into two separate halves. You will return at 1 week for one half of the top sutures to be removed, and at 2 weeks for the other half to be removed. Which half is removed first will be determined at random at your 1 week visit. At two months, you will return for standardized photographs which will be used by physicians to rate the cosmetic outcomes of the wound halves based on a standardized scale. Most likely, there will be no difference between the wound halves at 2 months and the study is complete. There is a small chance that there will be a cosmetic difference seen at 2 months, in which case you will return at 1 year for repeat standardized photographs and ratings. All data and photographs will be kept secure and any identifying information will be destroyed at the end of the study.

详细描述

This is an investigator initiated, single-center, prospective, randomized, evaluator-blinded split-scar study. Subjects will be recruited at the time of repair for Mohs surgery or excision based on the inclusion criteria above. Procedures will be performed by fellowship trained Mohs surgeons or fellows in training. The same surgeon will close the entire wound. At the time of wound closure, the wound will be divided into two equal halves. Subcutaneous 4-0 or 5-0 polyglecaprone sutures will be used to fully approximate the wound edges. Subcutaneous sutures will begin with one subcutaneous suture immediately in the center of the wound, followed by symmetrical subcutaneous sutures on both sides of the defect until the wound edges are approximated.

Once the wound edges are approximated, 5-0 nylon sutures will be used to align the epidermal edges in a running fashion, with sutures spaced 3-5mm apart and 2-3 mm from the wound edge. Suturing will begin at the wound poles and run towards the center. The running nylon sutures will be tied off separately for each wound half, which will facilitate suture removal in 1 or 2 weeks. Order of suturing the halves will be at the preference of the surgeon, as randomization will take place later at suture removal. The entire wound will then be dressed with a bandage, which will be left on 24 hours, at which point they may wash the site and change the bandage daily.

The patient will next present at 1 week (7 days) for randomization and suture removal of one half. The half that is either superior or on the patient's right will be labeled "A," and the other half will be labeled "B". This labeling will be photographed into the patient's electronic medical record and will be kept consistent for the remainder of the study. The patient will then be randomized using a random number generator (random.org), generating a number 1 or 2. If randomization yields a 1, then half A is removed first. If randomization yields a 2, then half B is removed first. The patient will return again at 2 weeks for removal of the second half of the nylon sutures.

At two months, patients will have standardized wound photographs taken: the wound will be re-labeled with "A" or "B" as it was at the time of suture removal. A Nikon SLR camera with 105mm macro lens, Wireless speedlight mounted on a ring, aperture F11, shutter 1/250 second, and Iso 64 will be consistent for all photographs. A standard grey background will be used, and the photograph will be taken at 90 degrees to the wound with the full face filling the frame.

The primary outcome will be the Scar Cosmesis Assessment and Rating scale (SCAR) score, with photographic assessment by three blinded fellowship-trained board-certified Mohs surgeons who were not involved with the original surgery or wound repair. There will be a preliminary statistical analysis, and if there is no difference between groups at 2-months, then the study will be ended (prior research has shown that if there is no difference at interim follow up, then the probability of difference at 1-year follow up is low enough as to not justify additional office visits for the patient). If there is a statistical difference seen at 2-months, then the study will continue through a 12-month visit, at which point repeat clinical photographs will be taken and evaluated as above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The primary outcome will be the Scar Cosmesis Assessment and Rating scale (SCAR) score, with photographic assessment by three blinded fellowship-trained board-certified Mohs surgeons who were not involved with the original surgery or wound repair.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •i. Adult patients >18 years ii. Undergoing Mohs surgery or excision with layered repair
  • •intermediate or complex layered closures measuring 2.6-7.5 cm on the face (including the forehead, temples, nose, cheeks, chin)
  • •Wound edges must be able to be approximated with subcutaneous sutures. iii. Ability to follow up at 1 week, 2 weeks, 2 months, and 1 year iv. Participants able to be enrolled at time of wound repair.

排除标准

  • •i. Facial defects involving the eyelid, mucosal lip, and ear ii. Pregnant or breastfeeding women iii. Children <18 years iv. Inability to comprehend English v. Inability to consent vi. Incarceration

研究组 & 干预措施

Suture removal at 1 week

Experimental

Cutaneous nylon suture removal of half of the split-scar at one week.

干预措施: Suture removal timing (Procedure)

Suture removal at 2 weeks

Experimental

Cutaneous nylon suture removal of half of the split-scar at two weeks.

干预措施: Suture removal timing (Procedure)

结局指标

主要结局

Scar Cosmesis Assessment and Rating scale (SCAR) score

时间窗: 2months (and possibly one year, see protocol)

1. Scar Cosmesis Assessment and Rating scale (SCAR), rated by three blinded observers based on digital photographs, with each half of the scar scored separately. This is a 0-13 rating with 0 representing the best possible scar.

次要结局

  • pain level with suture removal(measured at 1 and 2 weeks after suture removal)
  • difficulty of suture removal(measured at 1 and 2 weeks)
  • Patient scar satisfaction(At 2 months)
  • Presence of suture tracks(2 months)
  • Patient preference for 1 vs 2 week suture removal.(Asked at 2 months)
  • Rates of complications(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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