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Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

Primary Purpose

Nails, Ingrown, Coagulation Defect; Bleeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
collagen
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nails, Ingrown focused on measuring collagen, nail, ingrown, bleeding, surgery

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Collagen 1

    Collagen 2

    Control group

    Arm Description

    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

    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 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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    Postoperative inflammation
    The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold

    Full Information

    First Posted
    October 17, 2021
    Last Updated
    November 17, 2021
    Sponsor
    University of Seville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05140161
    Brief Title
    Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery
    Official Title
    Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2021 (Anticipated)
    Primary Completion Date
    December 29, 2021 (Anticipated)
    Study Completion Date
    February 21, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Seville

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nails, Ingrown, Coagulation Defect; Bleeding
    Keywords
    collagen, nail, ingrown, bleeding, surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Collagen 1
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Collagen 2
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    collagen
    Intervention Description
    use of hemostatic device in order to reduce bleeding in nail surgery
    Primary Outcome Measure Information:
    Title
    Bleeding
    Description
    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.
    Time Frame
    72 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    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
    Time Frame
    72 hours after surgery
    Title
    Postoperative inflammation
    Description
    The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold
    Time Frame
    72 hours after surgery
    Other Pre-specified Outcome Measures:
    Title
    Recovery time
    Description
    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
    Time Frame
    3 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ANTONIO CÓRDOBA FERNÁNDEZ, PHD
    Phone
    +34 685860512
    Email
    acordoba@us.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    participant data will only be available to the principal researcher

    Learn more about this trial

    Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

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