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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (wound care with a standard dressing) | Active Comparator | Patients receive wound care with a standard dressing (bandage) after surgery for 7 days. |
|
| Group II (NPWT) | Experimental | Patients receive NPWT after surgery for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Procedure | Receive wound care with NPWT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward H Chang | Contact | 713-794-1247 | eichang@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Edward H Chang | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Wound Care Management | Procedure | Receive wound care with a standard dressing (bandage) |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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