Prevention of wound complications following inguinal lymph node dissection in patients with penile cancer using epidermal vacuum-assisted wound closure (PräVAC)
Not Applicable
Recruiting
- Conditions
- wound complicationspenile cancerC60T89.03Malignant neoplasm of penis
- Registration Number
- DRKS00005257
- Lead Sponsor
- rologische Klinik und Poliklinik am Klinikum rechts der Isar der Technischen Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
• Patients with penile cancer and indication for inguinal lymph node dissection (tumor stage > pT1 G2 or palpable inguinal enlarged lymph nodes)
• Self-signed and –dated informed consent
Exclusion Criteria
• Previous inguinal surgery (e.g. after femoral bypass surgery) or other medical conditions already impairing lymphatic drainage (status post inguinal hernioplasty does not represent an exclusion criteria in case surgery hasn´t been performed within the last 3 months and no apparent impaired lymphatic drainage is present)
• Patients unable to understand the patient information or unable to consent
• Patients with known allergy to acrylic adhesive
• Age below 18 years
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cumulative drained exudate volume (ml) until removal of drainage (up to the 14th postoperative day)
- Secondary Outcome Measures
Name Time Method A) maximal drained exudate volume per day (ml)<br>B) duration of indwelling drainage (time until removal)<br>C) incidence of wound-associated complications (lymph edema, lymphocele, lymphorrhea, wound dehiscence, wound infection, thrombosis) [Time Frame: inpatient discharge + 3 months postoperatively]<br>D) duration of hospitalization<br>E) comparison of lymph node dissection-associated rate of reintervention (recurrent placement of drainage, puncture, re-operation, irradiation therapy, other therapeutic interventions) [Time Frame: inpatient discharge + 3 months postoperatively]<br>F) quality-of-life, patient´s satisfaction and comfort with wound treatment [Time Frame: preoperatively + inpatient discharge + 3 months postoperatively] -->QLQ-C30 (Version 3.0)<br>