Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

Not Applicable

• Conditions: Coagulation Defect; Bleeding; Nails, Ingrown
• Interventions: Device: collagen

• Registration Number: NCT05140161
• Lead Sponsor: University of Seville

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-17
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Study Start: 2021-12-20
• Primary Completion: 2021-12-29
• Study Completion: 2022-02-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen 1	collagen	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 2	collagen	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

Primary Outcome Measures

Name	Time	Method
Bleeding	72 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	72 hours after surgery	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
Postoperative inflammation	72 hours after surgery	The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold