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Control of Epistaxis With Surgiflo

NCT ID: NCT01051427

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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 the investigators 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.

The investigators 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 the investigators will put surgiflo and not in the other.The patient will be admitted to the hospital. The investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. The investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that the investigators will make hematological tests for haemoglobin and coagulation. To know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and the investigators will 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 the investigators can compare the discomfort.

The investigators have make statistic analysis, and they will need 24 patients for this trial. The investigators will need 2 years, approximately, to recruit them.

Conditions

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Epistaxis

Keywords

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Nasal packing Haemostatic matrix Epistaxis control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal catheter

In this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized not to put Surgiflo. So they receive the usual treatment with a nasal catheter balloon into the nose.

Group Type ACTIVE_COMPARATOR

Nasal catheter

Intervention Type DEVICE

In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.

Surgiflo

In this arm will be the patients with epistaxis that cannot be stopped with anterior nasal packing and are randomized to put into the nose Surgiflo.

Group Type EXPERIMENTAL

Surgiflo

Intervention Type DEVICE

Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.

Interventions

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Surgiflo

Before to put a nasal catheter to stop nasal bleeding when anterior packing fails, we'll try to stop bleeding with Surgiflo.

Intervention Type DEVICE

Nasal catheter

In patients randomized not to put Surgiflo, we use a nasal catheter to try to stop nasal bleeding.

Intervention Type DEVICE

Other Intervention Names

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Surgiflo haemostatic matrix. Invotec, Ultra Stat, nasal catheter.

Eligibility Criteria

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Inclusion Criteria

* Patients with epistaxis in emergency room.
* Epistaxis does not stop with anterior nasal packing.

Exclusion Criteria

* Pregnancy
* Allergy or intolerance to any component of Surgiflo.
* Septal perforation.
* Nasal surgery within 3 months previous to epistaxis.
* Patients admitted to hospital for other reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Gonzalo de los Santos

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gonzalo de los Santos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ramon y Cajal Hospital

Locations

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Ramon y Cajal Hospital

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Mathiasen RA, Cruz RM. Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis. Laryngoscope. 2005 May;115(5):899-902. doi: 10.1097/01.MLG.0000160528.50017.3C.

Reference Type BACKGROUND
PMID: 15867662 (View on PubMed)

Chandra RK, Conley DB, Kern RC. The effect of FloSeal on mucosal healing after endoscopic sinus surgery: a comparison with thrombin-soaked gelatin foam. Am J Rhinol. 2003 Jan-Feb;17(1):51-5.

Reference Type BACKGROUND
PMID: 12693656 (View on PubMed)

Woodworth BA, Chandra RK, LeBenger JD, Ilie B, Schlosser RJ. A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery. Am J Otolaryngol. 2009 Jan-Feb;30(1):49-53. doi: 10.1016/j.amjoto.2007.11.008. Epub 2008 Jun 16.

Reference Type BACKGROUND
PMID: 19027513 (View on PubMed)

Gudziol V, Mewes T, Mann WJ. Rapid Rhino: A new pneumatic nasal tamponade for posterior epistaxis. Otolaryngol Head Neck Surg. 2005 Jan;132(1):152-5. doi: 10.1016/j.otohns.2004.04.005.

Reference Type BACKGROUND
PMID: 15632931 (View on PubMed)

Other Identifiers

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ORLEPI1

Identifier Type: OTHER

Identifier Source: secondary_id

ORLEPI1

Identifier Type: -

Identifier Source: org_study_id