Breast CancerALEXNCT03942575
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
A study testing Negative pressure wound therapy in people with Breast Cancer and Wound Complication, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Wound Complication, Wound Infection
- 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
- 162 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 May 2019to 1 Jun 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Female sex
- Indication for mastectomy or modified radical mastectomy
Who cannot join
- Patients undergoing breast conserving therapy
- Patients undergoing direct breast reconstruction
- Unable to comprehend implications and extent of study and sign for informed consent
- Participation in other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of Postoperative Wound Complications Following the Use of Avelle Negative Pressure Wound Therapy in Patients Undergoing Mastectomy and Flap fiXation: a Pilot Study
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
Read the detailed description
Rationale:
Patients and breast cancer surgeons are frequently confronted with complications after mastectomy. These complications are manifold and mainly consist of: surgical site infections, seroma, wound dehiscence and wound necrosis. These complications are caused by numerous variables and therefore a multifactorial approach is required. Due to extensive research over the years, insight has been gained in how to reduce the rate of surgical site infections and wound healing problems. For example, pre-operatively and intra-operatively the complication rate can partly be influenced by optimizing intrinsic patient factors before surgery and using prophylactic antibiotics (1). There is however room for improvement in the postoperative phase. Negative pressure wound therapy (NPWT) has proven to be useful in reducing wound complications in all sorts of wounds. Limited evidence has been published on NPWT after breast cancer surgery and the effect of such in reducing wound complications.
This is a pilot study to evaluate the effect of negative pressure wound therapy in reducing postoperative wound complications after mastectomy, which might serve as a basis for a randomized controlled trial..
Objective:
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
Study design:
A prospective cohort will be compared to a historical control group. Fifty consecutive patients will undergo mastectomy with flap fixation using tissue glue and skin sutures, closed suction drainage AND Avelle negative pressure wound therapy.
These results will be compared to the results of a historical control group consisting of 112 patients who have undergone mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and in whom negative wound pressure therapy was omitted.
Follow-up will be conducted for three months post mastectomy.
Study population:
Female patients > 18 years diagnosed with invasive breast cancer or DCIS ( ductal carcinoma in situ) with an indication to perform mastectomy.
Intervention (if applicable):
Application of Avelle negative pressure wound therapy after standard mastectomy with flap fixation and closed suction drainage.
Main study parameters/endpoints:
Patients with postoperative wound complications during the first three postoperative months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at one week and three months. Additional study postoperative check-up will be performed at six weeks. Therefore, patients will be required to undergo one additional check-up. During out patients' visits, wound complication will be evaluated. Application of Avelle negative pressure wound therapy is expected to reduce wound complications and thereby benefit the post mastectomy wound healing process. The only potential risk for the patient is that the wound therapy would be ineffective or that the patient could develop an allergic reaction to the product. The latter is also a known risk of standard wound dressings.
- Being tested
- Negative pressure wound therapy
- Keywords
- Negative pressure wound therapy
- Medical subject headings
- Breast Neoplasms, 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
Wound dressing with negative pressure on closed incisions
| Study group | Role | What they receive |
|---|---|---|
| No negative pressure wound therapy | No intervention | Historical cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and where negative wound pressure therapy has been omitted |
| Negative pressure wound therapy | Experimental | Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy Receives: Device: Negative pressure wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with post-operative wound complications
Number of patients with post-operative wound complications defined as follows:
- Surgical site infection (SSI) is defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months.
- Wound necrosis. Defined as a wound with necrotic tissue that consists of an accumulation of dead cells, tissue and cellular debris and often requires debridement.
- Wound dehiscence or breakdown defined as a wound that ruptures along a surgical incision and the edges of the wound no longer align.
Measured: During the first three postoperative months
Secondary outcomes (2)
Number of unplanned visits to the ER or breast cancer clinic
Number of unplanned visits to the ER or breast cancer clinic. Planned visits are standard follow-up outpatient clinic visits which are defined preoperatively. Unplanned visits are defined as any visit to the outpatient clinic which is necessary due to an adverse event.
Measured: During the first three postoperative months
Number of patients with clinically significant seroma
Number of patients with clinically significant seroma. This is defined as:
- Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis)
- There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin.
- There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
Measured: During the first three postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start31 May 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A prospective cohort will be compared to a historical control group.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James van Bastelaar, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942575
- Sponsor's protocol ID
- METCZ20190024
- Acronym
- ALEX
- Status last verified
- Jul 2020
- First submitted
- 6 May 2019
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation. Sci Rep. 2021 May 5;11(1):9620. doi: 10.1038/s41598-021-89036-3.
PubMed 33953312
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Postoperative Wound Complications Following the Use of Avelle Negative Pressure Wound Therapy in Patients Undergoing Mastectomy and Flap fiXation: a Pilot Study
- ClinicalTrials.gov ID
- NCT03942575
- Acronym / sponsor ID
- ALEX / METCZ20190024
- Keywords
- Negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 8 May 2019 (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.
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
Detailed description
Rationale:
Patients and breast cancer surgeons are frequently confronted with complications after mastectomy. These complications are manifold and mainly consist of: surgical site infections, seroma, wound dehiscence and wound necrosis. These complications are caused by numerous variables and therefore a multifactorial approach is required. Due to extensive research over the years, insight has been gained in how to reduce the rate of surgical site infections and wound healing problems. For example, pre-operatively and intra-operatively the complication rate can partly be influenced by optimizing intrinsic patient factors before surgery and using prophylactic antibiotics (1). There is however room for improvement in the postoperative phase. Negative pressure wound therapy (NPWT) has proven to be useful in reducing wound complications in all sorts of wounds. Limited evidence has been published on NPWT after breast cancer surgery and the effect of such in reducing wound complications.
This is a pilot study to evaluate the effect of negative pressure wound therapy in reducing postoperative wound complications after mastectomy, which might serve as a basis for a randomized controlled trial..
Objective:
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
Study design:
A prospective cohort will be compared to a historical control group. Fifty consecutive patients will undergo mastectomy with flap fixation using tissue glue and skin sutures, closed suction drainage AND Avelle negative pressure wound therapy.
These results will be compared to the results of a historical control group consisting of 112 patients who have undergone mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and in whom negative wound pressure therapy was omitted.
Follow-up will be conducted for three months post mastectomy.
Study population:
Female patients > 18 years diagnosed with invasive breast cancer or DCIS ( ductal carcinoma in situ) with an indication to perform mastectomy.
Intervention (if applicable):
Application of Avelle negative pressure wound therapy after standard mastectomy with flap fixation and closed suction drainage.
Main study parameters/endpoints:
Patients with postoperative wound complications during the first three postoperative months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at one week and three months. Additional study postoperative check-up will be performed at six weeks. Therefore, patients will be required to undergo one additional check-up. During out patients' visits, wound complication will be evaluated. Application of Avelle negative pressure wound therapy is expected to reduce wound complications and thereby benefit the post mastectomy wound healing process. The only potential risk for the patient is that the wound therapy would be ineffective or that the patient could develop an allergic reaction to the product. The latter is also a known risk of standard wound dressings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective cohort will be compared to a historical control group.
| Arm | Type | Receives |
|---|---|---|
| No negative pressure wound therapy | No intervention | –Historical cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and where negative wound pressure therapy has been omitted |
| Negative pressure wound therapy | Experimental | Device: Negative pressure wound therapyProspective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years
- Female sex
- Indication for mastectomy or modified radical mastectomy
Key exclusion criteria (4 listed)
- Patients undergoing breast conserving therapy
- Patients undergoing direct breast reconstruction
- Unable to comprehend implications and extent of study and sign for informed consent
- Participation in other 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 therapyWound dressing with negative pressure on closed incisions | Device | Negative pressure wound therapy |
Primary outcome
Number of patients with post-operative wound complications
Time frame: During the first three postoperative months
Number of patients with post-operative wound complications defined as follows: 1. Surgical site infection (SSI) is defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months. 2. Wound necrosis. Defined as a wound with necrotic tissue that consists of an accumulation of dead cells, tissue and cellular debris and often requires debridement. 3. Wound dehiscence or breakdown defined as a wound that ruptures along a surgical incision and the edges of the wound no longer align.
2 secondary outcomes
Number of unplanned visits to the ER or breast cancer clinic
Time frame: During the first three postoperative months
Number of patients with clinically significant seroma
Time frame: During the first three postoperative months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 33953312De Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation. Sci Rep. 2021 May 5;11(1):9620. doi: 10.1038/s41598-021-89036-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wound Complication, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 2 Jul 2020. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with post-operative wound complications (time frame: During the first three postoperative months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942575, which also lists 1 linked publication.
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 2 Jul 2020.