Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial.
Chronic lower limb ulcers constitute a public health problem, with important socioeconomic implications and high attention cost. This trial evaluates handcrafted vacuum-assisted therapy versus traditional treatment effectiveness for lower limbs ulcers.



It was a prospective randomized clinical trial conducted over 144 patients with lower limbs ulcers. Patients were randomized into two groups of 72 patients: Experimental group were treated with debridement, cure and a handcrafted vacuum-assisted device that was changed every 72 h. Control group was treated with debridement and cure with soap every 24 h. Ulcers were evaluated every 72 h and on 10th day. The presence of systemic inflammatory response, pain, granulation tissue and viability for discharge was registered and analyzed .



After exclusion of 18 patients, 126 were included, 65.1% were men with an average of 58 years. Sole region ulcer by diabetic foot was the more frequent in both groups (73%). Leukocytes count, systemic inflammatory response and pain were significantly lower in experimental group (p < 0.05). Discharge criteria and granulation tissue were present earlier in experimental group (p < 0.05).



Handcrafted vacuum-assisted system is a feasible and safe method to treat chronic ulcers. This system would benefit patients favoring earlier infection control, faster granulation tissue appearance and earlier discharge. Clinical trials registered in https://www.clinicaltrials.gov/ Number NCT02512159.
General Surgery Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Israel Gonzalez
IG
Gonzalez
General Surgery, General Zone Hospital #30, Instituto Mexicano del Seguro Social, Mexico City, Mexico. medicaleditions@gmail.com.
Medina Andrade Luis
0000-0003-3711-3175
MA
Angel
Health Research Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Maria Valeria Jimenez
MV
Baez
General Surgery Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Brenda
B
Ruiz Flores
General Surgery Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Maria
M
de Los Angeles Martinez Ferretiz
General Surgery Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Stephanny Vanestty
SV
Woolf
General Surgery Department, Instituto Mexicano del Seguro Social, Hospital General Regional No. 17, Quintana Roo University, Av. Politécnico Manzana 1 Lote 1 Región 509, C.P. 55750, Cancún, Quintana Roo, Mexico.
Israel
I
López
Medical Assistant Coordination of Health Research, Mexican Social Security Institute, Cancún, Quintana Roo, Mexico.
Luis
L
Sandoval-Jurado
Family Medicine Unit No. 13, Mexican Social Security Institute, Cancún, Quintana Roo, Mexico.
Fany Guadalupe
FG
Pat-Espadas
General Surgery Department, The American British Cowdray Medical Center I.A.P, Universidad Nacional Autonoma de Mexico, Sur 136 #116, Col. Las Americas, Alvaro Obregon, C.P. 01120, Distrito Federal, Mexico.
Alan Alejandro Reyes
AA
Cruz
General Surgery Department, Hospital General de Tulancingo, Hidalgo, Mexico.
Arsenio Torres
AT
Delgado
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003646:Debridement; D004867:Equipment Design; D005260:Female; D006097:Granulation Tissue; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D054843:Negative-Pressure Wound Therapy; D011446:Prospective Studies; D064232:Visual Analog Scale; D014945:Wound Healing; D055815:Young Adult