Lymph nodal dissection of the groin in skin malignant melanoma surgery - does the dissection technique have an impact on wound healing: scalpel versus ultrasonic assisted versus electrocauter

ISRCTN	ISRCTN55731750
DOI	https://doi.org/10.1186/ISRCTN55731750
Protocol serial number	FKH-PCH-2008-1
Sponsor	Ethicon Endo-Surgery (Germany)
Funder	Ethicon Endo-Surgery (Germany) - received funding only; the study was independently performed and initiated by the hospital department

Submission date: 25/07/2008
Registration date: 17/12/2008
Last edited: 17/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Albrecht Krause-Bergmann
Scientific

Leitdender Arzt
Abteilung für Plastische und Ästhetische Chirurgie
Fachklinik Hornheide
Dorbaumstr. 300
Münster
48157
Germany

Email	krause-bergmann@fachklinik-hornheide.de

Study information

Primary study design	Interventional
Study design	Prospective, randomised, double blind, monocentric trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Ethics approval pending from the Ethikkommission der Ärtzekammer Westfalen Lippe as of 28/07/2008.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Length of hospital stay (days), evaluated at the time of hospital discharge of the patient
Key secondary outcome measure(s)	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
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Indication for a lymph nodal dissection of the groin for a skin malignant melanoma 2. Aged over 18 years, either sex
Key exclusion criteria	1. Non-consent 2. Aged under 18 years 3. Mentally disabled
Date of first enrolment	01/09/2008
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Germany

Study participating centre

Leitdender Arzt

Münster
48157
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes