Evaluating Hemopatch in reducing seroma related complications following axillary lymph node dissection: a pilot study

Completed

Conditions: 10006291
fluid collection
seroma formation

Registration Number: NL-OMON48337

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 64

Inclusion Criteria

- 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.

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess<br /><br>1. Proportion of patients treated with Hemopatch who develop clinically<br /><br>significant seroma during the first three post-operative months. Clinically<br /><br>significant seroma defined as:<br /><br>a. Wound healing is at risk due to seroma (wound break down, seroma<br /><br>leakage, necrosis) and possibly operative debriding of the wound or use of<br /><br>vacuum assisted wound therapy is necessary.<br /><br>b. The presence of discomfort or pain caused by large amounts of<br /><br>seroma, characterised by tenseness of the skin and aspiration is necessary<br /><br>c. The presence of contaminated/ infected seroma, and aspiration is<br /><br>necessary to treat infection. All patients that undergo seroma aspiration due<br /><br>to infection will also be treated with a one week course of Augmentin 625 mg 3<br /><br>times daily.<br /><br>d. Seroma for which incision and drainage is necessary to treat abscess<br /><br>or<br /><br>infection.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess<br /><br>1. Surgical site infection (SSI) rate, defined as redness, pain, heat<br /><br>or swelling at the site of the incision or by the drainage of pus. Infection<br /><br>rate will be measured by A) the need for antibiotics, B) seroma aspiration due<br /><br>to infection or C) surgical drainage during the first three postoperative<br /><br>months.<br /><br>2. The number of outpatient department visits, measured during the<br /><br>first three months postoperative.<br /><br>3. Number of days before removal of axillary drainage and axillary<br /><br>drainage output. According to current guidelines the drain is always removed no<br /><br>later than five days, earlier if drain output is < 50 ml/ 24 hours </p><br>