CompletedNot Applicable

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

Netherlands62 participantsStarted 2020-06-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: During the first three postoperative months

Trial details

NCT IDNCT04185480

SponsorZuyderland Medisch Centrum

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-01

View on ClinicalTrials.gov More Axillary Lymph Node Dissection trials