The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Soft Tissue Ischemia/Loss
研究概览
简要总结
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental. The objective is to compare the techniques and the incidence of perfusion related problems in patient's undergoing mastectomy with immediate breast reconstruction.
详细描述
This study's aim is to evaluate and compare a variety of interventions and their effect on the incidence of perfusion related problems in patients with breast cancer undergoing mastectomy and implant-based immediate breast reconstruction (IBR). The ability to identify, prevent and treat these perfusion related problems can help maximize aesthetic results after breast surgery, improve patient satisfaction with both mastectomy and breast reconstruction, and reduce healthcare cost associated with mastectomy and reconstruction complications.The study team will perform a randomized pilot study comprised of eight groups. All of these groups employ accepted techniques, medications and dressings and therefore are not experimental.
Group 1: Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.
Group 2 - Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.
Group 3 - Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.
Group 4 - Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be female.
- •Patients must be between the ages of 18 and 99 years.
- •Patients must undergo mastectomy with our attending breast oncology surgeons followed by possible implant-based immediate breast reconstruction (IBR) performed by our attending plastic surgeons at WFBMC.
- •Patients must have the ability to understand and the willingness to sign an IRB-approved informed consent document.
排除标准
- •Patients who are under the age of 18 or over the age of
- •Patients who are undergoing mastectomy without immediate breast reconstruction including immediate breast reconstruction with autologous tissue (or combination of autologous tissue with tissue expanders or implants), or patients with a history of mastectomy presenting for delayed breast reconstruction.
- •Patients with pre-existing conditions in which use of indocyanine-green is contraindicated or must be used with caution, including those with a history of allergy to iodides or iodinated dye, those with chronic kidney disease, those with hepatic failure or cirrhosis of the liver, and females who are nursing, pregnant, or may become pregnant.
- •Pregnant women are excluded from this study because pregnancy precludes immediate breast reconstruction in our patient population.
- •Patients with pre-existing conditions in which use of nitroglycerin paste is contraindicated, including those with a history of cardiac insufficiency, hypotension, sensitivity to nitrites, severe liver impairment, glaucoma, hyperthyroidism, recent head trauma, severe anemia, or taking certain medication (i.e. alteplase, aspirin, beta-blocker, calcium channel blocker, diuretics or thiazides).
- •Patients with pre-existing conditions in whom use of incisional negative pressure wound therapy is contraindicated including those with evidence of surgical site infection ( i.e. erythema, purulent drainage), clinical signs of hematoma (i.e. wound swelling, fluctuance, blood drainage), history of persistent cancer, exposed blood vessel on site of proposed therapeutic use, or sensitivity to acrylics and adhesives.
研究组 & 干预措施
Group 1
Breast skin after mastectomy will be clinically examined by the surgeon to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No treatment, including dye study, ointment, or vacuum dressing will be applied to the breast after implant placement.
干预措施: No treatment (Other)
Group 2
Breast skin after mastectomy will be clinically examined by the surgeon, and nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This cream does not have systemic effects but may improve blood flow to the remnant breast skin after mastectomy.
干预措施: Nitroglycerin (Drug)
Group 3
Breast skin after mastectomy will be clinically examined by the surgeon, and an incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after implant placement, which may improve blood flow to the skin and help wound healing.
干预措施: Negative Pressure Wound Therapy/ Wound VAC (Device)
Group 4
Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.
干预措施: Nitroglycerin (Drug)
Group 4
Breast skin after mastectomy will be clinically examined by the surgeon, and both NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions after implant placement.
干预措施: Negative Pressure Wound Therapy/ Wound VAC (Device)
Group 5
Blood flow to breast skin after mastectomy will be examined using a fluorescent dye study called fluorescent angiography (FA) to determine if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No further intervention will be used after implant placement.
干预措施: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) (Other)
Group 6
Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.
干预措施: Nitroglycerin (Drug)
Group 6
Blood flow to breast skin breast skin will be examined using FA, and NTG cream will be applied to the skin after the implant is placed.
干预措施: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) (Other)
Group 7
Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.
干预措施: Negative Pressure Wound Therapy/ Wound VAC (Device)
Group 7
Blood flow to breast skin breast skin will be examined using FA, and an iVAC will be placed over breast skin incisions after the implant is placed.
干预措施: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) (Other)
Group 8
Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.
干预措施: Nitroglycerin (Drug)
Group 8
Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.
干预措施: Negative Pressure Wound Therapy/ Wound VAC (Device)
Group 8
Blood flow to breast skin breast skin will be examined using FA, and both NTG cream and iVAC will be used as interventions after the implant is placed.
干预措施: Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg) (Other)
结局指标
主要结局
Number of Soft Tissue Ischemia/Loss
时间窗: Up to 30 days
Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up
Number of Participants With Surgical Site Infection
时间窗: Up to 30 days
Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture
Number of Participants With Delayed Wound Healing
时间窗: Up to 30 days
manifesting as suture dehiscence and opening of an incisional wound
次要结局
- Number of Participants With Operative Intervention Secondary to Perfusion Related Problems(Up to 30 days)
- Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications(up to 30 days)
- Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics(Up to 30 days)