Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial

• Published in: World journal of surgery Vol. 41; no. 2; pp. 386 - 393
• Main Authors: Gonzalez, Israel Gonzalez, Angel, Medina Andrade Luis, Baez, Maria Valeria Jimenez, Ruiz Flores, Brenda, de los Angeles Martinez Ferretiz, Maria, Woolf, Stephanny Vanestty, López, Israel, Sandoval-Jurado, Luis, Pat-Espadas, Fany Guadalupe, Cruz, Alan Alejandro Reyes, Delgado, Arsenio Torres
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.02.2017; Springer Nature B.V
• Subjects: Abdominal Surgery; Adult; Aged; Aged, 80 and over; Cardiac Surgery; Chronic Ulcer; Chronic Wound; Debridement; Discharge Criterion; Equipment Design; Female; General Surgery; Granulation Tissue; Humans; Innovative Surgical Techniques Around the World; Leg Ulcer - therapy; Leukocyte Count; Male; Medicine; Medicine & Public Health; Middle Aged; NCT; NCT02512159; Negative-Pressure Wound Therapy; Prospective Studies; Surgery; Thoracic Surgery; Vascular Surgery; Visual Analog Scale; Visual Analogue Pain Score; Wound Healing; Young Adult; Discharge Criterion; Visual Analogue Pain Score; Chronic Ulcer; Chronic Wound; Granulation Tissue
• ISSN: 0364-2313; 1432-2323
• DOI: 10.1007/s00268-016-3782-9

Background 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. Materials and methods 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 . Results 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). Conclusion 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.