Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study

NCT04185480 | Completed

• 1 other identifier: METCZ20190124
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate if the use of Hemopatch in axillary lymph node dissection shows potential in reducing clinically significant seroma and seroma related complications, which might serve as a basis for a randomized controlled trial.

Conditions

Axillary Lymph Node Dissection; ALND; Axillary Clearance; Seroma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months

  Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months. Clinically significant seroma defined as: 1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) and possibly operative debriding of the wound or use of vacuum assisted wound therapy is necessary. 2. The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary 3. The presence of 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. 4. Seroma for which incision and drainage is necessary to treat abscess or infection.

  During the first three postoperative months

Secondary Outcomes (3)

• Surgical site infection (SSI) rate

  During the first three postoperative months

• The number of outpatient department visits

  During the first three postoperative months

• Number of days before removal of axillary drainage and axillary drainage output.

  During the first three postoperative months

Study Arms (2)

Conventional

NO INTERVENTION

Historical cohort of patients that underwent axillary clearance without hemopatch.

Intervention

EXPERIMENTAL

Prospective cohort of patient undergoing axillary clearance with hemopatch

Device: Hemopatch

Interventions

Hemopatch DEVICE

Before closure of the wound this hemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis will be applied in the axilla

Intervention

Eligibility Criteria

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

You may qualify if:

• Male and female patients of 18 years or older.
• Patients with melanoma and indication for axillary lymph node dissection.
• Patients with breast cancer and indication for breast conserving therapy and axillary lymph node dissection
• Patients with an indication for secondary axillary lymph node dissection.

You may not qualify if:

• Patients with breast cancer who have an indication for modified radical mastectomy.
• Unable to comprehend implications and extent of study and sign for informed consent
• Pregnant women
• Patients included in another breast related clinical trial

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Sittard, Limburg, 6162 BG, Netherlands

Location

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: December 2, 2019
• First Posted: December 4, 2019
• Study Start: June 16, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)