Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery
NCT ID: NCT05140161
Last Updated: 2021-12-01
Study Results
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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UNKNOWN
NA
98 participants
INTERVENTIONAL
2021-12-20
2022-02-21
Brief Summary
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It is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).
Detailed Description
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In the experimental groups, once the surgical procedure has been completed on both edges of the nail, hemostatic collagen will be applied in the experimental groups (experimental group 1- medium porosity collagen and experimental group 2-high porosity collagen) In all groups, including the control, once the intervention was finished, the same bandage was performed with the same number of gauze pads.
At 72 hours, the gauze set will be removed to weigh it using a precision balance and quantitatively evaluate the amount of bleeding.
In this way, a comparative study can be carried out between the 3 groups and determine if there are statistically significant differences or not, and can determine if lyophilized hemostatic collagen is useful in nail surgery and if there are significant differences between both experimental groups, determining if the percentage of porosity in a hemostatic is relevant in the hemostatic effect.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Collagen 1
Medium porosity collagen sponge is used in the operated nail grooves. The hallux is covered with a non-stick dressing, five gauze surrounding it and a cohesive bandage
collagen
use of hemostatic device in order to reduce bleeding in nail surgery
Collagen 2
High porosity collagen sponge is used in the operated nail grooves. The hallux is covered with a non-stick dressing, five gauze surrounding it and a cohesive bandage
collagen
use of hemostatic device in order to reduce bleeding in nail surgery
Control group
No hemostatic device is used in the nail grooves. No hemostatic device is used in the nail grooves. Only non-stick dressing, five gauze pads and cohesive bandage are used
No interventions assigned to this group
Interventions
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collagen
use of hemostatic device in order to reduce bleeding in nail surgery
Eligibility Criteria
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Inclusion Criteria
* Susceptible to phenol-alcohol technique with Suppan I modification
Exclusion Criteria
* Oral Anticoagulant Therapy
* History of congenital or acquired Hemorrhagic Syndrome
* Alteration in the following parameters (platelet count, prothrombin time, activated thromboplastin time, and plasma fibrinogen)
15 Years
70 Years
ALL
Yes
Sponsors
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University of Seville
OTHER
Responsible Party
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Antonio Córdoba-Fernández PhD
PhD, Principal Investigator, Clinical Professor
Central Contacts
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Other Identifiers
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1206-N-15
Identifier Type: -
Identifier Source: org_study_id