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Control of Epistaxis With Surgiflo

2014-08-27 03:16:34 | BioPortfolio

Summary

This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. So the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.

Description

Epistaxis is one of the most frequent diseases in Otolaryngology emergencies. Most of them are anterior and stop with an anterior packing. Some of them does not stop with this, therefore we have to put into the nose a catheter balloon. This is very painful and has many after-effects in the nose.

Surgiflo is a haemostatic matrix used for bleeding.

We have design a trial to know if some people can benefit from Surgiflo instead to put a nasal catheter.

This a randomized trial with two arms. In one arm we'll put surgiflo and not in the other.The patient will be admitted to the hospital. We'll see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. We´ll report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that we'll make hematological tests for haemoglobin and coagulation. To know the discomfort of the device we'll give the patient an analog visual scale in the moment we put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and we'll see the patient again in the office after 15 days, 1, 3 and 6 months.

All the patients will receive the same analgesic protocol so we can compare the discomfort.

We have make statistic analysis, and we'll need 24 patients for this trial. We´ll need 2 years, approximately, to recruit them.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Epistaxis

Intervention

Surgiflo, Nasal catheter

Location

Ramon y Cajal Hospital
Madrid
Spain
28034

Status

Recruiting

Source

Hospital Universitario Ramon y Cajal

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

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