Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

University of Seville

Status: Unknown

Conditions: Coagulation Defect; Bleeding; Nails, Ingrown

Treatments: Device: collagen

Study type: Interventional

Funder types: Other

Identifiers

NCT05140161

1206-N-15

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 3 patient groups

Collagen 1

Experimental group

Description:

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

Treatment:

Device: collagen

Collagen 2

Experimental group

Description:

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

Treatment:

Device: collagen

Control group

No Intervention group

Description:

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