Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

NCT05140161 | Unknown

• 1 other identifier: 1206-N-15
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Nails, Ingrown; Coagulation Defect; Bleeding

Keywords

collagen; nail; ingrown; bleeding; surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain

  72 hours after surgery

• Postoperative inflammation

  72 hours after surgery

Other Outcomes (1)

• Recovery time

  3 weeks after surgery

Study Arms (3)

Collagen 1

EXPERIMENTAL

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

Device: collagen

Collagen 2

EXPERIMENTAL

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

Device: collagen

Control group

NO INTERVENTION

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

Interventions

collagen DEVICE

use of hemostatic device in order to reduce bleeding in nail surgery

Collagen 1; Collagen 2

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Nails, Ingrown; Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ANTONIO CÓRDOBA FERNÁNDEZ, PHD

CONTACT

+34 685860512; acordoba@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: December 1, 2021
• Study Start: December 20, 2021
• Primary Completion: December 29, 2021
• Study Completion: February 21, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share