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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy

Clinicaltrials.gov identifier NCT03942575

Recruitment Status Completed

First Posted May 8, 2019

Last update posted July 2, 2020

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

  • Condition or Disease:Wound Complication
    Breast Cancer
    Wound Infection
    Wound Dehiscence
    Wound Necrosis
  • Intervention/Treatment: Device: Negative pressure wound therapy
  • Phase: N/A
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
  • Study Type: Interventional
  • Actual Enrollment: 162 participants
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: A prospective cohort will be compared to a historical control group.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: June 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Negative pressure wound therapy
Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy
Device: Negative pressure wound therapy
Wound dressing with negative pressure on closed incisions
Outcome Measures
  • Primary Outcome Measures: 1. 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: 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: 1. Number of unplanned visits to the ER or breast cancer clinic [ Time Frame: During the first three postoperative months ]
    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.
  • 2. Number of patients with clinically significant seroma [ Time Frame: During the first three postoperative months ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Netherlands, Limburg
Zuyderland Medisch Centrum
Sittard

Sponsors and Collaborators

Zuyderland Medisch Centrum

More Information
  • Responsible Party: Zuyderland Medisch Centrum
  • ClinicalTrials.gov Identifier: NCT03942575 History of Changes
  • Other Study ID Numbers: METCZ20190024
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: July 2, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Zuyderland Medisch Centrum: Negative pressure wound therapy
  • Additional relevant MeSH terms: Wound Infection
    Necrosis
    Wounds and Injuries