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
About this trial
This is an interventional treatment trial for Nails, Ingrown focused on measuring collagen, nail, ingrown, bleeding, surgery
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)
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
NCT ID
NCT05140161
First Posted
October 17, 2021
Last Updated
November 17, 2021
Sponsor
University of Seville
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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