Negative Pressure Wound Therapy for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Obesity+4 More
Negative Pressure Wound Therapy - Procedure
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether negative pressure wound therapy may help improve wound healing for obese patients undergoing breast reconstruction surgery.

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Eligible Conditions

  • Obesity
  • Malignant Breast Neoplasm
  • Body Mass Index Greater Than or Equal to 30
  • Mammoplasty Patient

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Negative Pressure Wound Therapy will improve 2 primary outcomes in patients with Obesity. Measurement will happen over the course of Up to 3 months.

Up to 3 months
Rate of wound dehiscence
Wound healing complications

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Group I (wound care with a standard dressing)
1 of 2
Group II (NPWT)
1 of 2
Active Control
Experimental Treatment

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Negative Pressure Wound Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Group II (NPWT)
Procedure
Patients receive NPWT after surgery for 7 days.
Group I (wound care with a standard dressing)
Procedure
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Negative Pressure Wound Therapy
2017
N/A
~920

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
Patients are willing and able to give consent.
Body mass index (BMI) greater than or equal to 30.0.

Patient Q&A Section

What is breast cancer?

"Breast cancer begins when cells grow incorrectly, divide incorrectly or do not die after development. The body attempts to fight the abnormal cells. Breast cancer causes tumours by continually growing new cells. This can be a result of inheritance of genes that control cell growth or the result of exposure to a toxic substance. In most cases the cause is unknown. Diagnosis is usually by inspection of the breasts and nipple for anything suspicious under a microscope. Diagnosis may also include a chest X-ray or CT scan." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"Results from a recent clinical trial confirms the previously observed disparity in prostate cancer among black men and breast cancer among white women by showing a substantially higher incidence of black women aged 50 years and older diagnosed with breast cancer. The data also suggest that the disparity is unlikely to be the result of differences in staging, access, or treatment. Results from a recent clinical trial highlight the need to evaluate breast cancer disparities in further studies, particularly among older black women, and to develop and test innovative breast cancer risk-reduction strategies among such populations." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include lump, swelling or changing size, nipple discharge, and nipple pain. They are most noticeable in women in early puberty who experience menstruation. Breast cancer usually manifests as delayed menstruation or as a lump in the breast. As the cancer progresses, symptoms progress to a lump, new lump near the existing one, nipple discharge, red color or ulcer, and feeling different sensations. When breast cancer is suspected in a postmenopausal woman, a full medical history is essential. When breast cancer is suspected in a premenopausal woman, it is advisable to discuss all the symptoms to a general practitioner. Screening is an option to be evaluated based on the symptoms." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Common options include surgery, chemotherapy, radiation therapy, and targeted therapy, or a combination of these. Often mastectomy is recommended to allow treatment to take effect.\n" - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"There is no clear single cause for breast cancer; instead, various agents are thought to affect risk. The link between risk factors and a specific cause for breast cancer is being strengthened with improved study methods and techniques. The role of environmental factors in breast cancer will become clearer if new prospective studies provide further evidence in this direction." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"There is currently no evidence for the usefulness of radical mastectomy. Treatment of early breast cancer may improve survival, but treatment is only curative for a minority. Overall survival for all breast cancer patients is not improved by systemic treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"The age of diagnosis for invasive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is 71.0 years. The mortality rate from breast cancer is 5.0%. It should be noted the time of diagnosis can be either recent (within the past 3 years) or late (more than 10 years). It is important to understand that many stage 1 cancers never progress to stage 2 and early stage. It is also an important thing to understand that mortality rates are also affected by the stage of the cancer. More importantly, if there was a cure available, people would live longer." - Anonymous Online Contributor

Unverified Answer

What is negative pressure wound therapy?

"Findings from a recent study of this study do not prove wound healing with negative pressure wound therapy; however, it does suggest that the method might provide a better cosmetic outcome than conventional wound dressing with dressings. Moreover, negative pressure wound therapy does not necessarily have a negative effect on wound healing. A better cosmetic outcome may translate into an increased patient satisfaction with care." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"Breast carcinomas are associated with alterations in normal tissue, a large fraction of which are caused by DNA damage. DNA damage and other genomic lesions are frequently associated with epigenetic changes and with other phenotypic alterations in breast carcinoma. Genetic damage may be induced by hormones, metabolic changes, and viral agents. There is a complex interplay between these causes of genomic damage and these other lesions in breast cancer, but at this time it remains insufficiently understood." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast cancer?

"Clinical trials are of some value in assessing the effectiveness of new treatments. Clinical trials may also be used to obtain further insights into certain subgroups of patients. Trials of personalized chemotherapy for breast cancer and of targeted therapies are being studied. Trials in which specific therapies are studied in particular subpopulations of patients could provide evidence for effectiveness of adjuvant and neoadjuvant chemotherapy, chemotherapy before operation, and hormone receptor antagonists." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of negative pressure wound therapy?

"To our knowledge, this is the first study examining the common side effects of NPWT in a post hoc analysis of a randomised trial. The common problems arising in the course of the trial were not different from reports published in the literature on NPWT. It is therefore the opinion of the authors that NPWT is safe as an adjuvant therapy in the treatment of non-healing wound healing, particularly for the relief of pain. Further studies are probably needed to validate these observations in a broader study population and to optimise patient selection for NPWT." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"Most nurses are concerned about the severity of breast cancer and do not believe in the risk in their patient's condition. The level of confidence in their treatment can be influenced by the familiarity of their patients to their own health status and the perceived severity of their condition. The more familiarity a clinician can gain from his/her experiences in caring for patients with breast cancer, the higher confidence they have in their treatment. In a recent study, findings imply that future interventions should focus on enhancing nurses' knowledge and confidence about the severity of breast cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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