Nails, IngrownNCT05140161
Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery
A study testing collagen in people with Nails, Ingrown and Coagulation Defect; Bleeding, run by University of Seville.
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). Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nails, Ingrown, Coagulation Defect; Bleeding
- What is being tested?
- collagen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2021to 21 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- Nails, Ingrown, Coagulation Defect; Bleeding
- Being tested
- collagen
- Keywords
- collagen, nail, ingrown, bleeding, surgery
- Medical subject headings
- Nails, Ingrown, Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagenDevice
use of hemostatic device in order to reduce bleeding in nail surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after surgery
Secondary outcomes (2)
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
Measured: 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
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start20 Dec 2021 (estimated)
- Primary completion29 Dec 2021 (estimated)
- Study completion21 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nails, IngrownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Córdoba-Fernández PhD, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140161
- Sponsor's protocol ID
- 1206-N-15
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data will only be available to the principal researcher
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05140161
- Acronym / sponsor ID
- 1206-N-15
- Conditions
- Nails, Ingrown, Coagulation Defect; Bleeding
- Keywords
- collagen, nail, ingrown, bleeding, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 29 Dec 2021 (estimated)
- Study completion
- 21 Feb 2022 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collagen 1 | Experimental | Device: collagenMedium 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 |
| Collagen 2 | Experimental | Device: collagenHigh 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 |
| 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 |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagenuse of hemostatic device in order to reduce bleeding in nail surgery | Device | Collagen 1, Collagen 2 |
Primary outcome
Bleeding
Time frame: 72 hours after surgery
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.
2 secondary outcomes
Postoperative pain
Time frame: 72 hours after surgery
Postoperative inflammation
Time frame: 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No. participant data will only be available to the principal researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing collagen in people with Nails, Ingrown and Coagulation Defect; Bleeding, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANTONIO CÓRDOBA FERNÁNDEZ, PHD (+34 685860512, acordoba@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.