Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Nails, Ingrown; Coagulation Defect; Bleeding
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANTONIO CÓRDOBA FERNÁNDEZ, PHD; Phone Number: +34 685860512; Email: acordoba@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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	Device: collagen; use of hemostatic device in order to reduce bleeding in nail surgery
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	Device: collagen; use of hemostatic device in order to reduce bleeding in nail surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 20, 2021
• Primary Completion (ANTICIPATED): December 29, 2021
• Study Completion (ANTICIPATED): February 21, 2022

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (ACTUAL): December 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: collagen; surgery; bleeding; nail; ingrown
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Hematologic Diseases; Hemorrhagic Disorders; Nail Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Nails, Ingrown
• Other Study ID Numbers: 1206-N-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: participant data will only be available to the principal researcher

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No