No registrations found.
ID
Source
Brief title
Health condition
Wondgenezing, post-operatieve complicaties en pathologische littekenvorming.
Wound healing, post-operative complications and pathological scar formation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters will concern wound healing complications (infection, seroma, hematoma, dehiscence, reoperation).
Secondary outcome
The secondary parameters will concern the outcomes of scar quality (POSAS, Cutometer®, SCAR-Q and DSM-II colormetric evaluation). Additional endpoints will be revision surgery, CHEST-Q scores, nipple survival and nipple sensitivity.
Study objective
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).
Study design
The primary endpoint is at 1 month post-op, whereas the secondary endpoint is at 1 one year post-op
Intervention
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.
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
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
Inclusion criteria
• 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.
Exclusion criteria
• 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7213 |
| NTR-old | NTR7412 |
| Other | NL64838.029.18 : 2018.145 |