Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial

Conditions
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Nails, Ingrown, Coagulation Defect; Bleeding

Intervention / Treatment
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* Device: collagen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STADIUM I, II, or III (Kline classification) without infective onychocryptosis (cellulitis) on both edges of the Hallux Susceptible to phenol-alcohol technique with Suppan I modification Exclusion Criteria: Platelet Antiplatelet Therapy 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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen 1<br>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 | Device: collagen<br>* use of hemostatic device in order to reduce bleeding in nail surgery<br>|
| Experimental: Collagen 2<br>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 | Device: collagen<br>* use of hemostatic device in order to reduce bleeding in nail surgery<br>|
| No Intervention: Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | The polypropylene non-stick dressing together with 5 gauze pads from the same manufacturer will be weighed using a precision scale. 72 hours after surgery once the cohesive bandage has been removed, the gauze and the non-stick dressing in contact with the wounds will be weighed equally. | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | To measure the postoperative pain, an analog chromatic visual scale for self-evaluation of pain (scale from 0 =absence of pain to 10 =unbearable pain) will be used | 72 hours after surgery | 
| Postoperative inflammation | The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold | 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collagen, nail, ingrown, bleeding, surgery