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Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery

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ClinicalTrials.gov Identifier: NCT04003038
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Body Mass Index Greater Than or Equal to 30 Malignant Breast Neoplasm Mammoplasty Patient Obesity Procedure: Negative Pressure Wound Therapy Procedure: Wound Care Management Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group I (wound care with a standard dressing)
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Procedure: Wound Care Management
Receive wound care with a standard dressing (bandage)
Other Names:
  • Wound Care
  • Wound Care Treatment
  • Wound Management
  • Wound Treatment

Experimental: Group II (NPWT)
Patients receive NPWT after surgery for 7 days.
Procedure: Negative Pressure Wound Therapy
Receive wound care with NPWT
Other Names:
  • NPWT
  • Vacuum-Assisted Wound Closure




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003038


Contacts
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Contact: Edward H Chang 713-794-1247 eichang@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Edward I. Chang    713-794-1247      
Principal Investigator: Edward I. Chang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Edward H Chang M.D. Anderson Cancer Center

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04003038     History of Changes
Other Study ID Numbers: 2018-0004
NCI-2019-02777 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0004 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases