Clinical trial NCT03942575: The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Wound Complication
Wound Infection
Wound Dehiscence
Wound Necrosis
Keywords: Negative pressure wound therapy
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A prospective cohort will be compared to a historical control group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients with post-operative wound complications
timeFrame: During the first three postoperative months
Secondary outcomes:
measure: Number of unplanned visits to the ER or breast cancer clinic
timeFrame: During the first three postoperative months
measure: Number of patients with clinically significant seroma
timeFrame: During the first three postoperative months
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum
state: Limburg
Study officials:
References:
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.