Body Mass Index Greater Than or Equal to 30NCT04003038
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
A study testing Negative Pressure Wound Therapy and Wound Care Management in people with Body Mass Index Greater Than or Equal to 30 and Malignant Breast Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient
- What is being tested?
- Negative Pressure Wound Therapy and Wound Care Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2019to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are unable to provide consent.
- Patients who are suspected or known to be pregnant.
- Known allergy to topical adhesives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Edward I. Chang, 713-794-1247
Edward I. Chang
About this study
Official title: A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate.
II. Long-term follow-up on wound healing complications.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
GROUP II: Patients receive negative pressure wound therapy (NPWT) after surgery for 7 days.
After completion of study, patients are followed up at 2 weeks, and at 1 and 3 months.
- Conditions
- Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity
- Being tested
- Negative Pressure Wound Therapy, Wound Care Management
- Medical subject headings
- Breast Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyProcedure or surgery
Also called NPWT, Vacuum-Assisted Wound Closure
Receive wound care with NPWT
Wound Care ManagementProcedure or surgery
Also called Wound Care, Wound Care Treatment, Wound Management, Wound Treatment
Receive wound care with a standard dressing (bandage)
| Study group | Role | What they receive |
|---|---|---|
| Group I (wound care with a standard dressing) | Active comparator | Patients receive wound care with a standard dressing (bandage) after surgery for 7 days. Receives: Procedure: Wound Care Management |
| Group II (NPWT) | Experimental | Patients receive NPWT after surgery for 7 days. Receives: Procedure: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound dehiscence
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Measured: Up to 3 months
Wound healing complications
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start2 May 2019
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Mass Index Greater Than or Equal to 30Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward H Chang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003038
- Sponsor's protocol ID
- 2018-0004
- Other IDs
- NCI-2019-02777, 2018-0004, P30CA016672
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
- ClinicalTrials.gov ID
- NCT04003038
- Acronym / sponsor ID
- 2018-0004
- Conditions
- Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.
Detailed description
PRIMARY OBJECTIVES:
- Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate.
II. Long-term follow-up on wound healing complications.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
GROUP II: Patients receive negative pressure wound therapy (NPWT) after surgery for 7 days.
After completion of study, patients are followed up at 2 weeks, and at 1 and 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (wound care with a standard dressing) | Active comparator | Procedure: Wound Care ManagementPatients receive wound care with a standard dressing (bandage) after surgery for 7 days. |
| Group II (NPWT) | Experimental | Procedure: Negative Pressure Wound TherapyPatients receive NPWT after surgery for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who are unable to provide consent.
- Patients who are suspected or known to be pregnant.
- Known allergy to topical adhesives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyAlso: NPWT, Vacuum-Assisted Wound ClosureReceive wound care with NPWT | Procedure or surgery | Group II (NPWT) |
| Wound Care ManagementAlso: Wound Care, Wound Care Treatment, Wound Management, Wound TreatmentReceive wound care with a standard dressing (bandage) | Procedure or surgery | Group I (wound care with a standard dressing) |
Primary outcome
Rate of wound dehiscence
Time frame: Up to 3 months
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Wound healing complications
Time frame: Up to 3 months
Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward H Chang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Wound Care Management in people with Body Mass Index Greater Than or Equal to 30 and Malignant Breast Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward H Chang (713-794-1247, eichang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of wound dehiscence (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.