Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
研究概览
简要总结
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern
详细描述
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be unknown to PI and additional care providers until an envelope is opened by research staff at the time of final layer closure in the OR.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult females 18-65 years of age
- •Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
- •Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
- •Willing to follow wound care therapy as instructed by study staff.
- •Willing to return for follow up visits and undergo study evaluations.
排除标准
- •Individuals diagnosed with known allergy to general adhesives/adhesive tape
- •Individuals with a history of using the following prescription medications:
- •Accutane within the past year;
- •Systemic steroid use within the past year
- •Individuals who have significant scarring on the test site/area(s)
- •Individuals with malnutrition
- •Individuals who have a body mass index >35
- •Individual who have a history of radiation therapy
- •Individual who have a history of breast cancer
- •Active smokers
- •Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease
- •Individual who have an observable pre-operative or intra-operative breast asymmetry that, in the investigators opinion, would interfere with the evaluation of the efficacy of the wound therapy
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
时间窗: 6 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M
时间窗: 3 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M
时间窗: 12 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M
时间窗: 12 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M
时间窗: 3 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M
时间窗: 6 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
次要结局
- Scar Area Assessment(Week 2, Week 4, Week 6 and Week 8)
- Change in Tissue Stiffness(Baseline, 3 Months, 6 Months, and 12 Months)
- Histology Collagen 1(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
- Interleukin-8 (IL8)(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
- Measure of the Skins Function(Baseline, 3 Months, 6 Months, and 12 Months)
- Change in Tissue Density(Baseline, 3 Months, 6 Months, and 12 Months)
- Change in Tissue Thickness(Baseline, 3 Months, 6 Months, and 12 Months)
- Change in Tissue Energy Absorption(Baseline, 3 Months, 6 Months, and 12 Months)
- Gene Regulation- Elastin(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
- Gene Analysis- Macrophage(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
- Histology Collagen 3(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
- Scar Maximum Depth(Week 2, Week 4, Week 6 and Week 8)
- Change in Mechanical Properties of Human Tissue(Baseline, 3 Months, 6 Months, and 12 Months)
- Interleukin-6 (IL6)(Baseline, 4 Week, 8 Week, 3 Months, 12 Months)
研究者
Jeffrey M. Kenkel
Professor of Medicine
University of Texas Southwestern Medical Center