The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy (ALEX)
Primary Purpose
Breast Cancer, Wound Complication, Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Negative pressure wound therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Negative pressure wound therapy
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years
- Female sex
- Indication for mastectomy or modified radical mastectomy
Exclusion Criteria:
- 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
Sites / Locations
- Zuyderland Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No negative pressure wound therapy
Negative pressure wound therapy
Arm Description
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
Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03942575
Brief Title
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
Acronym
ALEX
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Wound Complication, Wound Infection, Wound Dehiscence, Wound Necrosis
Keywords
Negative pressure wound therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort will be compared to a historical control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No negative pressure wound therapy
Arm Type
No Intervention
Arm Description
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
Arm Title
Negative pressure wound therapy
Arm Type
Experimental
Arm Description
Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy
Intervention Description
Wound dressing with negative pressure on closed incisions
Primary Outcome Measure Information:
Title
Number of patients with post-operative wound complications
Description
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.
Time Frame
During the first three postoperative months
Secondary Outcome Measure Information:
Title
Number of unplanned visits to the ER or breast cancer clinic
Description
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.
Time Frame
During the first three postoperative months
Title
Number of patients with clinically significant seroma
Description
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.
Time Frame
During the first three postoperative months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 years
Female sex
Indication for mastectomy or modified radical mastectomy
Exclusion Criteria:
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
Facility Information:
Facility Name
Zuyderland Medisch Centrum
City
Sittard
State/Province
Limburg
ZIP/Postal Code
6162 BG
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33953312
Citation
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.
Results Reference
derived
Learn more about this trial
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
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