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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.
The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drenovac handcrafted | Experimental | Patients treatment with the handicraft topical device negative pressure therapy Economic craft |
|
| Healing | Active Comparator | Patients who were managed with traditional "conservative treatment". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drenovac handcrafted | Procedure | under local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of granulation tissue in skin ulcers. | Presence of granulation tissue in 50% of the wound | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte less than 11,000 mm3. | Leukocyte less than 11,000 mm3. | 10 days |
| Temperature | less than 38 ° C temperature. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fany Guadalupe Pat Espadas, MCs | IMSS | Principal Investigator |
| Israel Augusto González González, Dr. | IMSS | Study Chair |
| Luis Sandoval Jurado, PhD | IMSS | Study Director |
| Ma. Valeria Jiménez Baéz, PhD | IMSS | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27822727 | Derived | Gonzalez IG, Angel MA, Baez MV, Ruiz Flores B, de Los Angeles Martinez Ferretiz M, Woolf SV, Lopez I, Sandoval-Jurado L, Pat-Espadas FG, Cruz AA, Delgado AT. Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial. World J Surg. 2017 Feb;41(2):386-393. doi: 10.1007/s00268-016-3782-9. |
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| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
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| Healing | Procedure | Were handled as follows:
|
|
| Breathing Rate | less than 20 rpm breathing rate. | 10 days |
| Heart Rate | lower heart rate 90 bpm. | 10 days |
| D012883 |
| Skin Ulcer |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003925 | Diabetic Angiopathies |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |