The treatment with ciNPT results in a superior healing when compared to the standard treatment (no ciNPT). The rationale behind the secondary outcome is that this treatment leads to improvement of scar quality in comparison to the standard treatment…
ID
Bron
Verkorte titel
Aandoening
Wondgenezing, post-operatieve complicaties en pathologische littekenvorming.
Wound healing, post-operative complications and pathological scar formation.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary parameters will concern wound healing complications (infection, seroma, hematoma, dehiscence, reoperation).
Doel van het onderzoek
The treatment with ciNPT results in a superior healing when compared to the standard treatment (no ciNPT). The rationale behind the secondary outcome is that this treatment leads to improvement of scar quality in comparison to the standard treatment (no ciNPT).
Onderzoeksopzet
The primary endpoint is at 1 month post-op, whereas the secondary endpoint is at 1 one year post-op
Onderzoeksproduct en/of interventie
The bilateral mastectomy sites will be closed conventionally and in accordance to standard practice. All mastectomies will be randomly assigned one control side and one case side that will receive the additional ciNPT treatment.
Publiek
Dept. of Plastic, Reconstructive and Hand Surgery
VU University Medical Center
De Boelelaan 1117
Amsterdam 1081 HZ
The Netherlands
+31-20-4443520
f.timmermans@vumc.nl
Wetenschappelijk
Dept. of Plastic, Reconstructive and Hand Surgery
VU University Medical Center
De Boelelaan 1117
Amsterdam 1081 HZ
The Netherlands
+31-20-4443520
f.timmermans@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Only patients that meet the age criterion of >18 years old will be considered for participation.
• Written informed consent by the patient and/or legal representative
• Trans men that request a bilateral mastectomy as a masculinization procedure.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
• Severe drug, smoking (> 1 pack a day; 22 cigarettes) and alcohol abuse (>10 alcoholic units a week)
• Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7213 |
| NTR-old | NTR7412 |
| Ander register | NL64838.029.18 : 2018.145 |