Thinking of joining a study?

Register your interest

NCT05140161 | Unknown status | Nails, Ingrown


Hemostasis Assessment After Application of Lyophilisate Collagen in Nail Surgery
Sponsor:

University of Seville

Information provided by (Responsible Party):

Antonio Córdoba-Fernández PhD

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).

Condition or disease

Nails, Ingrown

Coagulation Defect; Bleeding

Intervention/treatment

collagen

Phase

Not Applicable

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 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

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

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

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
Criteria
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)

Hemostasis Assessment After Application of Lyophilisate Collagen in Nail Surgery

Location Details


Please Choose a site



Hemostasis Assessment After Application of Lyophilisate Collagen in Nail Surgery

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Loading...