Reduction of the rate of lymphatic fistula by intraoperative use of 4DryField®PH

Not Applicable

• Conditions: T31.8; Burns involving 80-89% of body surface

• Registration Number: DRKS00028160
• Lead Sponsor: niversitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

The patient is at least 18 years old and at most 90 years old
- Written documented informed consent and agreement to participate in the study
- Patients who are able to follow study instructions and are likely to adhere to all required study visits (compliance)
- Patients who are scheduled for axillary or inguinal lymph node dissection

Exclusion Criteria

- Patient is unable to understand the scope, significance, and consequences of this clinical trial
- Known allergy to any of the components of the medical device
- Known or ongoing abuse of medications, drugs, or alcohol
- Lack of suitability of the patient to participate in the study as determined by the investigator
- Active disseminated coagulation disorder
- Patients with chronic lymphedema of the extremity to be operated on
- Emergency surgery

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention time of the drainage <br>(Removal of the redon drainage from a flow rate <40ml/24h without suction and without sonographic evidence of an obstruction; removal of the suction if the flow rate is reduced by 2/3 within 24h or if the flow rate is <50ml/24h)

Secondary Outcome Measures

Name	Time	Method
- Drainage volume<br>- wound infections<br>- Length of hospital stay <br>- Repeat drain placement/puncture<br>- Recording of days until continuation of system therapy