Nails, Ingrown, Coagulation Defect; Bleeding
Conditions
Keywords
collagen, nail, ingrown, bleeding, surgery
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.
Interventions
DEVICEcollagen
use of hemostatic device in order to reduce bleeding in nail surgery
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 72 hours after surgery | 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 | 72 hours after surgery | The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | 3 weeks after surgery | 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 |
Contacts
Primary ContactANTONIO CÓRDOBA FERNÁNDEZ, PHD
Outcome results
None listed