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

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.

Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC).

BACKGROUND: Appendectomy is the most frequent and urgent gastrointestinal surgery. Overtime, the surgical techniques have been improved upon, in order to reduce complications, get better cosmetic results, and limit the discomfort associated with this procedure, by its high impact in the surgery departments. The traditional skin closure is associated with a poor cosmetic result and it requires stitches removal, alongside the pain associated with this procedure, and no benefits were demonstrated in the literature regarding separated stitches over intradermic stitch. This is a randomized controlled trial, and our objective is to compare two different skin closure techniques in open appendectomy. METHODS: A prospective randomized trial method was used, with a total number of 208 patients participating in the study, after acute appendicitis diagnosis in the emergency department. They were randomized into two groups: patients who would receive skin closure with a unique absorbable intradermic stitch (Group A) and another group that would receive the traditional closure technique, consistent in non-absorbable separated stitches (Group B). General characteristics like gender, age, Body Mass Index (BMI), comorbidities, and allergies were registered. Days of Evolution (DOE) until surgery, previous use of antibiotics, complicated or uncomplicated appendicitis, surgical time, and wound complications like skin infection, dehiscence, seroma or abscess were also registered in each case. RESULTS: 8 patients were excluded due to negative appendicitis during surgery and lack of follow-up. Two groups, each containing 100 patients, were formed. General characteristics and parity were compared, and no statistically significant differences were observed. Difference in the surgical time (Group A: 47.35 min vs Group B: 54.13 min, p < .001) and cases with complicated appendicitis (Group A: 58 and Group B:38, p = .005) were found to be statistically significant. Four wound complications were reported, and the incidence of seroma (Group A:0 and Group B:5, p = .02) and abscess (Group A:2 and Group B:8, p = .05) were found to have some statistical significant difference. In a multivariate analysis, a relationship was observed between BMI > 25 kg/m2 and seroma (p = .006), BMI > 25 kg/m2 and abscess (p = .02), surgical time >50 min and seroma (p < .001), >2 DOE and abscess (p = .001), and complicated appendicitis with seroma development (p = .03). CONCLUSION: Open appendectomy skin closure with a unique absorbable intradermic stitch is safe, with a reduced seroma and abscess incidence, compared to traditional closure, and an equivalent dehiscence and superficial infection incidence, allowing a lower hospital attention cost and length of hospital stay for treatment of complications. The relative risk of complications with traditional skin closure is 2.91 higher, compared to this new technique.