Skin Ulcers Treatment With an Handicraft Topical Device

Summary

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.

Conditions

• Foot Ulcer
• Varicose Ulcer

Interventions

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.

PROCEDURE

Healing

Were handled as follows: 1. 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. 2. healing of skin ulcers were performed every 24 hours. 3. the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  collaborator OTHER_GOV

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• Fany Guadalupe Pat Espadas, MCs · IMSS

• Israel Augusto González González, Dr. · IMSS

• Luis Sandoval Jurado, PhD · IMSS

• Ma. Valeria Jiménez Baéz, PhD · IMSS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2014-10-31

Completion

2015-01-31