Breast Cancer Clinical Trial
— NPWTinDIEPOfficial title:
Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
NCT number | NCT05338281 |
Other study ID # | 120134 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2023 |
Est. completion date | October 2025 |
Verified date | April 2023 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy - Patients going either unilateral or bilateral reconstruction Exclusion Criteria: - Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. - - Patients who have contraindications to the ciNPT - Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study. - Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada | Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative Surgical Site Infection (SSI) | The post-operative SSI at the abdomen will be determined following the Center for Disease Control (CDC) criteria. This includes one or more of the following:
1. Purulent drainage from the incision, 2. Organisms identified from an aseptically-obtained specimen 3. Superficial incision with one of the following signs or symptoms localized pain or tenderness; localized swelling; erythema; or heat. d. Diagnosis of a superficial incisional SSI by a physician or designee |
30 days after operation | |
Secondary | The rate of seroma diagnosis | The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography. | 30 days after operation | |
Secondary | The rate of hematoma diagnosis | The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography. | 30 days after operation | |
Secondary | The rate of wound dehiscence | The diagnosis of wound dehiscence will be made by clinical exam. | 30 days after operation |
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