NCT05140161

Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nails, Ingrown
• Coagulation Defect; Bleeding

Interventions

Type	Name	Description
DEVICE	collagen	use of hemostatic device in order to reduce bleeding in nail surgery

Timeline

• Start date: 2021-12-20
• Primary completion: 2021-12-29
• Completion: 2022-02-21
• First posted: 2021-12-01
• Last updated: 2021-12-01