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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagen | Device | use of hemostatic device in order to reduce bleeding in nail surgery |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANTONIO CÓRDOBA FERNÁNDEZ, PHD | Contact | +34 685860512 | acordoba@us.es |
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participant data will only be available to the principal researcher
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| ID | Term |
|---|---|
| D009263 | Nails, Ingrown |
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014652 | Vascular Diseases |
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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 |
| D002318 |
| Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |