Israel Gonzalez Gonzalez1, Medina Andrade Luis Angel2, Maria Valeria Jimenez Baez3, Brenda Ruiz Flores1, Maria de Los Angeles Martinez Ferretiz1, Stephanny Vanestty Woolf1, Israel López1, Luis Sandoval-Jurado4, Fany Guadalupe Pat-Espadas5, Alan Alejandro Reyes Cruz6, Arsenio Torres Delgado7. 1. 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. 2. General Surgery, General Zone Hospital #30, Instituto Mexicano del Seguro Social, Mexico City, Mexico. medicaleditions@gmail.com. 3. 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. 4. Medical Assistant Coordination of Health Research, Mexican Social Security Institute, Cancún, Quintana Roo, Mexico. 5. Family Medicine Unit No. 13, Mexican Social Security Institute, Cancún, Quintana Roo, Mexico. 6. 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. 7. General Surgery Department, Hospital General de Tulancingo, Hidalgo, Mexico.
Abstract
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.
RCT Entities:
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.
Authors: Mark L Venturi; Christopher E Attinger; Ali N Mesbahi; Christopher L Hess; Katherine S Graw Journal: Am J Clin Dermatol Date: 2005 Impact factor: 7.403
Authors: Harold Brem; Peter Sheehan; Harvey J Rosenberg; Jillian S Schneider; Andrew J M Boulton Journal: Plast Reconstr Surg Date: 2006-06 Impact factor: 4.730
Authors: Zhenmi Liu; Jo C Dumville; Robert J Hinchliffe; Nicky Cullum; Fran Game; Nikki Stubbs; Michael Sweeting; Frank Peinemann Journal: Cochrane Database Syst Rev Date: 2018-10-17