Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

Coagulation Defect; Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05140161
• Other study ID #: 1206-N-15
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: November 2021
• Source: University of Seville
• Contact: ANTONIO CÓRDOBA FERNÁNDEZ, PHD
• Phone: +34 685860512
• Email: acordoba[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: February 21, 2022
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemorrhage
• Hemostatic Disorders
• Nails, Ingrown

Intervention

Device:
• collagen
use of hemostatic device in order to reduce bleeding in nail surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recovery time	Recovery time clinical indicators will be considered when there is absence of drainage, when granulation tissue is covered by a scab, when there were no signs of erythematous tissue without evidence of infection	3 weeks after surgery
Primary	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	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
Secondary	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