Skin Ulcers Treatment With an Handicraft Topical Device

Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb

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.

Study Overview

• Status: Completed
• Conditions: Foot Ulcer; Varicose Ulcer
• Intervention / Treatment: Procedure: drenovac handcrafted; Procedure: Healing

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.
2. Patients of both sexes.
3. Patients over 18 years.
4. Patients that have basic laboratory at admission (complete blood count with differential).
5. Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.

Exclusion Criteria:

1. Hemodynamically unstable patients.
2. Patients with septic shock from any source.
3. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
4. Patients with secondary cutaneous ulcer enteral fistula.
5. Patients with cutaneous ulcer or cancer tumors.
6. Patients with cutaneous ulcer with active bleeding.
7. Patients with cutaneous ulcer necrosis.
8. Patients with cutaneous ulcer leishmania, insect bite.
9. Patients with cutaneous ulcer burns.
10. Patients who do not accept their participation in the study through informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drenovac handcrafted; Patients treatment with the handicraft topical device negative pressure therapy Economic craft	Procedure: drenovac handcrafted; 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.
Active Comparator: Healing; Patients who were managed with traditional "conservative treatment".	Procedure: Healing; Were handled as follows: Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze.; healing of skin ulcers were performed every 24 hours.; the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of granulation tissue in skin ulcers.	Presence of granulation tissue in 50% of the wound	10 days

Secondary Outcome Measures

Outcome Measure	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
Breathing Rate	less than 20 rpm breathing rate.	10 days
Heart Rate	lower heart rate 90 bpm.	10 days

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborators: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Fany Guadalupe Pat Espadas, MCs, IMSS; Study Chair: Israel Augusto González González, Dr., IMSS; Study Director: Luis Sandoval Jurado, PhD, IMSS; Study Chair: Ma. Valeria Jiménez Baéz, PhD, IMSS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Wound management; Foot care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Foot Diseases; Varicose Veins; Foot Ulcer; Ulcer; Varicose Ulcer; Skin Ulcer
• Other Study ID Numbers: 2014-2301-12