NCT04003038

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
May 2019Apr 2028

Study Start

First participant enrolled

May 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

9 years

First QC Date

June 27, 2019

Last Update Submit

April 20, 2026

Conditions

Body Mass Index Greater Than or Equal to 30Malignant Breast NeoplasmMammoplasty PatientObesity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 3 months

Study Arms (2)

Group I (wound care with a standard dressing)

ACTIVE COMPARATOR

Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.

Procedure: Wound Care Management

Group II (NPWT)

EXPERIMENTAL

Patients receive NPWT after surgery for 7 days.

Procedure: Negative Pressure Wound Therapy

Interventions

Negative Pressure Wound TherapyPROCEDURE

Receive wound care with NPWT

Also known as: NPWT, Vacuum-Assisted Wound Closure
Group II (NPWT)
Wound Care ManagementPROCEDURE

Receive wound care with a standard dressing (bandage)

Also known as: Wound Care, Wound Care Treatment, Wound Management, Wound Treatment
Group I (wound care with a standard dressing)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are unable to provide consent.
  • Patients who are suspected or known to be pregnant.
  • Known allergy to topical adhesives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsObesity

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Edward H Chang

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward H Chang

CONTACT

713-794-1247eichang@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

May 2, 2019

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(1)