Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and late reconstructions. The complications rates reported in the literature are around 30% for delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site infection rate is approximately 7% and seroma formation rate is approximately 1.2%.
In many of the procedures closed suction drains are left for fluid drainage, in order to reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in this study is to describe the relation between the placement of closed suction drains, the timing for their removal, and immediate post operative complications.
Patients that underwent breast reconstruction with silicone prosthesis and in which drains will be left in the surgical field would be randomly assigned into two groups: a control group, in which drains will be removed when the daily discharge will be below 20 cc for two consecutive days and the study group, in which drains will be removed on post operative day (POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications such as infection, seroma, hematoma and skin necrosis was record and analyzed.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- patients that underwent immediate or late breast reconstruction with silicone prosthesis (expanders/implants)and in which closed suction drains were left in the operating field according to the decision of the operating surgeon.
- signature of informed consent form
Exclusion Criteria:
- age under 18
- breast reconstruction without prosthesis
- Breast reconstruction without the use of drains
- Active infection during time of surgery in surgical site
- Coagulation disease
- Psychiatric illness
- Immune disease
- Lack of communication or language problems
- Foreign residents, not Israeli citizens
- Prisoners
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
control
drains would be removed when daily discharge will be below 20 cc for 2 consecutive days
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
|
|
study
drains will be removed on post operative day (POD) 10
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- SHEBA -08-5530 -EW- CTIL
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .