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 |
| Secondary identifying numbers | FKH-PCH-2008-1 |
- 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
Scientific
Leitdender Arzt
Abteilung für Plastische und Ästhetische Chirurgie
Fachklinik Hornheide
Dorbaumstr. 300
Münster
48157
Germany
| krause-bergmann@fachklinik-hornheide.de |
Study information
| Study design | Prospective, randomised, double blind, monocentric trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2008 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 (40 patients per group) |
| 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
48157
Germany
Sponsor information
Ethicon Endo-Surgery (Germany)
Industry
Industry
Hummelsbütteler Steindamm 71
Norderstedt
22851
Gibraltar
"ROR" |
https://ror.org/023edjq13 |
|---|
Funders
Funder type
Industry
Ethicon Endo-Surgery (Germany) - received funding only; the study was independently performed and initiated by the hospital department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
