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

NCT03942575 | Completed DMC

• 1 other identifier: METCZ20190024
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Wound Complication; Wound Infection; Wound Dehiscence; Wound Necrosis

Keywords

Negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Number of patients with post-operative wound complications

  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.

  During the first three postoperative months

Secondary Outcomes (2)

• Number of unplanned visits to the ER or breast cancer clinic

  During the first three postoperative months

• Number of patients with clinically significant seroma

  During the first three postoperative months

Study Arms (2)

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

Device: Negative pressure wound therapy

Interventions

Negative pressure wound therapy DEVICE

Wound dressing with negative pressure on closed incisions

Negative pressure wound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Female sex
• Indication for mastectomy or modified radical mastectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Sittard, Limburg, 6162 BG, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33953312 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Infections

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon, Principal Investigator, MD, PhD

Model Details: A prospective cohort will be compared to a historical control group.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: May 31, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)