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临床试验/NCT02166138
NCT02166138Unknown不适用

Non-Ablative Fractional Resurfacing of Total Knee Replacement Scars

Charles Cornell, MD1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
108
试验地点
1
主要终点
The change in POSAS scores between patients in the laser treated group and the not laser treated group at 4 weeks, 8 weeks, 3 month, and 1 year follow up visits.

研究概览

简要总结

The condition to be studied is post-surgical scarring following primary total knee replacement, specifically whether fractional non-ablative laser therapy can be used to significantly decrease the morbidity of scarring.

详细描述

Patients undergoing unilateral, primary total knee replacement will be enrolled in the study in the treating surgeon's office at the time surgery is indicated and scheduled. Patient's will be asked to enroll in the study if they are indicated by the treating surgeon for primary total knee replacement, are 18 years of age or older, and, if they have no history of wound healing problems, chronic infection or connective tissue disorder and if they have a Fitzpatrick skin type between I and VI. Patients will be excluded from the study if they: have any prior history of surgery on the indicated knee; have a mental or psychological illness that prohibits them from consenting or completing the necessary forms; if they refuse to consent to be in the study; or, if they have a history of wound healing problems, or a diagnosed skin or connective tissue disease. Standard baseline health information and demographics will be collected at the time of enrollment (gender, age, co-morbidities, etc.).

On the day of surgery, patients will be randomized to have their surgical incision treated with the non-ablative fractional laser or treated with the placebo laser. Randomization will be computer-generated and stored in opaque sealed envelopes. For each patient, randomization will take place prior to surgery in the holding area on the day of surgery. At discharge, the laser technician will open the sealed envelope to reveal the allocation into control or experimental groups. The technician will then treat the patient appropriately as per the protocol. Proper randomization will be ensured by the technician, principal investigator and co-investigators. The patients, principal investigator and co-investigators collecting the data will be blinded to the randomization. The technician providing the laser therapy will not be blinded.

The incisional length will be determined by the treating surgeon at the time of surgery based on what he deems will be adequate given the patient's body habitus and the technical demands of the surgery. The skin incision will always be made with a new, sharp, sterile 10 blade. Subcutaneous dissection will be done with the scalpel as well.

Closure of the wound will be done with 0-vicryl sutures for the arthrotomy and deep subcutaneous tissue. The sutures will be tied in an interrupted simple pattern. The superficial subcutaneous tissue layer will be closed with interrupted buried 2.0-vicryl sutures. The skin will be closed with a 4.0 monocryl running subcuticular stitch. The wound will be dressed with a sterile dressing that will come off on post operative day two.

After the primary dressing is taken down, the wound will be left open to air unless there is active drainage. If active drainage is present, sterile gauze will be kept on the wound until it is dry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

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

  • •Patients will be included if:
  • •They are indicated for primary total knee replacement
  • •Have no history of wound healing problems, chronic infection, or known skin or connective tissue disease.
  • •Are 18 years of age or older
  • •Have a skin type classified as a Fitzpatrick type I-VI.

排除标准

  • •Patients will be excluded for the following reasons:
  • •Any prior history of surgery on their knee
  • •Mental or psychological illness that prohibits the patient from completing the necessary forms

研究组 & 干预措施

Laser treated Group

Experimental

Patients in this group will be given the laser treatment with the non-abilative 1540 nm wavelength. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits. Thus, patients in this group will be getting the Non-Abilative laser treatment.

干预措施: Non-Abilative Laser treatment (Procedure)

Not Laser treated Group

Placebo Comparator

Patients in this group will be given the laser treatment with the 1540 non-abilative laser device, but the device will not be set to provide treatment. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits.

结局指标

主要结局

The change in POSAS scores between patients in the laser treated group and the not laser treated group at 4 weeks, 8 weeks, 3 month, and 1 year follow up visits.

时间窗: 4 week, 8 week, 3 month, and 1 year follow up visits

The primary outcome will be the difference in patient reported POSAS score between those patients that received laser therapy and those who did not receive laser therapy. The POSAS will be collected at the 4 week, 8 week, 3 month and 12 month time points. The POSAS consists of two scales: the patient scale and the observer scale. Both scales consist of six items that are scored numerically. The six items on the observer scale are: scar vascularity, pigmentation, pliability, thickness, relief and surface area. The six items scored by patients are: pain, itching, color, pliability, thickness and relief. Each of the six items is scored from 1-10 with 10 indicating the worst imaginable scar outcome. Each of the scores for the six items is added up for a cumulative score between 6 and 60 where 6 represents normal skin and 60 represents the worst scar imaginable. Both the patient and observer scale have been found to be reliable and valid in the evaluation of linear, surgical scars.

次要结局

  • KOOS(4 week, 8 week, 3 month, and 1 year follow up visits)

研究者

发起方
Charles Cornell, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Charles Cornell, MD

MD

Hospital for Special Surgery, New York

研究点 (1)

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