Breast CancerNPWTinDIEPNCT05338281
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
A study testing Negative Pressure Wound Therapy in people with Breast Cancer and Surgical Site Infection, run by Western University, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Surgical Site Infection, Wound Dehiscence
- What is being tested?
- Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
- Patients going either unilateral or bilateral reconstruction
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
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.
Read the detailed description
The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.
- Conditions
- Breast Cancer, Surgical Site Infection, Wound Dehiscence
- Being tested
- Negative Pressure Wound Therapy
- Keywords
- DIEP, Negative Pressure Wound Therapy, Breast Reconstruction
- Medical subject headings
- Breast Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called Prevena™ Incision Management System
The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital. Receives: Device: Negative Pressure Wound Therapy |
| Standard Dressing | Active comparator | This group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape. Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- Diagnosis of a superficial incisional SSI by a physician or designee
Measured: 30 days after operation
Secondary outcomes (3)
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.
Measured: 30 days after operation
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.
Measured: 30 days after operation
The rate of wound dehiscence
The diagnosis of wound dehiscence will be made by clinical exam.
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study startSep 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Study details changed, new Trial Registration process begun for modified protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Principal investigator, Tanya DeLyzer, Western University, Canada
- Investigators
- Tanya DeLyzer, MD, FRCSC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338281
- Sponsor's protocol ID
- 120134
- Acronym
- NPWTinDIEP
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT
- ClinicalTrials.gov ID
- NCT05338281
- Acronym / sponsor ID
- NPWTinDIEP / 120134
- Conditions
- Breast Cancer, Surgical Site Infection, Wound Dehiscence
- Keywords
- DIEP, Negative Pressure Wound Therapy, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study details changed, new Trial Registration process begun for modified protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 21 Apr 2022 (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.
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.
Detailed description
The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyThis group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, AND the negative pressure wound therapy. The Prevena™ Incision Management System will be placed at the abdominal flap donor site after incision is closed. The Prevena™ will remain for up to 5 days, or until patient is discharged from the hospital. |
| Standard Dressing | Active comparator | Device: Negative Pressure Wound TherapyThis group will receive the usual care of the abdominal donor wound following DIEP flap-based breast reconstruction surgery, and standard dressing which will be composed of gauze, secured with paper tape. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
- Patients going either unilateral or bilateral reconstruction
Key exclusion criteria (4 listed)
- 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.
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: Prevena™ Incision Management SystemThe negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements. | Device | Negative Pressure Wound Therapy, Standard Dressing |
Primary outcome
Postoperative Surgical Site Infection (SSI)
Time frame: 30 days after operation
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
3 secondary outcomes
The rate of seroma diagnosis
Time frame: 30 days after operation
The rate of hematoma diagnosis
Time frame: 30 days after operation
The rate of wound dehiscence
Time frame: 30 days after operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tanya DeLyzer, MD, FRCSC principal investigator
London Health Sciences Centre
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 in people with Breast Cancer and Surgical Site Infection, run by Western University, Canada at 1 site in Canada.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Apr 2023. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Surgical Site Infection (SSI) (time frame: 30 days after operation). 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 19 Apr 2023.