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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48337

Enrollment

Registered

2019-11-06

Start date

2020-06-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fluid collection seroma formation

Interventions

Application of Hemopatch after standard axillary lymph node dissection.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To assess 1. Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months. Clinically significant seroma defined as: a. 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. b. The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary c. 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. d. Seroma for which incision and drainage is necessary to treat abscess or infection.	—

Measure

Time frame

To assess 1. Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months. Clinically significant seroma defined as: a. 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. b. The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary c. 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. d. Seroma for which incision and drainage is necessary to treat abscess or infection.

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Secondary

Measure	Time frame
To assess 1. Surgical site infection (SSI) rate, 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. The number of outpatient department visits, measured during the first three months postoperative. 3. Number of days before removal of axillary drainage and axillary drainage output. According to current guidelines the drain is always removed no later than five days, earlier if drain output is	—

Measure

Time frame

To assess 1. Surgical site infection (SSI) rate, 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. The number of outpatient department visits, measured during the first three months postoperative. 3. Number of days before removal of axillary drainage and axillary drainage output. According to current guidelines the drain is always removed no later than five days, earlier if drain output is

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)