Condition category
Surgery
Date applied
25/07/2008
Date assigned
17/12/2008
Last edited
17/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Ethicon Endo-Surgery (Germany)

Sponsor details

Hummelsbütteler Steindamm 71
Norderstedt
22851
Gibraltar

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes