Contact information
Type
Scientific
Primary contact
Dr Albrecht Krause-Bergmann
ORCID ID
Contact details
Leitdender Arzt
Abteilung für Plastische und Ästhetische Chirurgie
Fachklinik Hornheide
Dorbaumstr. 300
Münster
48157
Germany
krause-bergmann@fachklinik-hornheide.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FKH-PCH-2008-1
Study information
Scientific title
Acronym
Study hypothesis
Lymph nodal dissection of the groin for melanoma of the skin is known as a high wound complication procedure. The surgical procedure has been described very similarly for decades. For the tissue dissection there are different well-experienced techniques. These are the traditional scalpel dissection, the ultrasonic assisted and the electrocauter assisted dissection technique. All equipment is CE certified and use is currently up to the surgeons referrals.
Evidence based decision making should be standard in todays medical treatment. In surgery evidence-based data is very rare. Concerning the described question for the impact of the dissection technique for the groin dissection there is no data available. Wound healing is a major problem in this group of patients. In medical literature a complication rate up to almost 50% (wound infection, healing problems, seroma, lymph fistula, lymphoedema, etc.) is being reported.
Ethics approval
Ethics approval pending from the Ethikkommission der Ärtzekammer Westfalen Lippe as of 28/07/2008.
Study design
Prospective, randomised, double blind, monocentric trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Wound healing in skin malignoma surgery
Intervention
The surgical procedure is the same for all the patients. There will be three groups for the different tissue dissection techniques:
1. Dissection with the scalpel/scissors
2. Ultrasonic assisted dissection
3. Electrocautery assisted dissection
The follow-up will be 3 months in all arms.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Length of hospital stay (days), evaluated at the time of hospital discharge of the patient
Secondary outcome measures
1. Amount of wound drainage (ml), evaluated at the time of hospital discharge of the patient
2. Time of drainage in situ (days), evaluated at the time of hospital discharge of the patient
3. Cost of treatment (Euro), evaluated after the 3 month follow-up
Overall trial start date
01/09/2008
Overall trial end date
30/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Indication for a lymph nodal dissection of the groin for a skin malignant melanoma
2. Aged over 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 (40 patients per group)
Participant exclusion criteria
1. Non-consent
2. Aged under 18 years
3. Mentally disabled
Recruitment start date
01/09/2008
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Leitdender Arzt
Münster
48157
Germany
Funders
Funder type
Industry
Funder name
Ethicon Endo-Surgery (Germany) - received funding only; the study was independently performed and initiated by the hospital department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary