University of Seville
Antonio Córdoba-Fernández PhD
The objective of this study is to evaluate the hemostatic capacity of two types of collagen hemostatic sponges in nail surgery. It is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).
Nails, Ingrown
Coagulation Defect; Bleeding
collagen
Not Applicable
To evaluate bleeding, all patients with onychocryptosis will be operated on with the same technique. 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.}}
Study Type : | Interventional |
Estimated Enrollment : | 98 participants |
Masking : | Triple |
Primary Purpose : | Treatment |
Official Title : | Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial |
Actual Study Start Date : | December 20, 2021 |
Estimated Primary Completion Date : | December 29, 2021 |
Estimated Study Completion Date : | February 21, 2022 |
Arm | Intervention/treatment |
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Experimental: 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 |
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Experimental: 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 |
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No Intervention: 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 |
Ages Eligible for Study: | 15 Years to 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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