BackgroundSkin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient. Our hypothesis is that simple wound irrigation with nonsterile water for postoperative wound care after an abscess is surgically drained is feasible. We assume that in terms of reinfection and reintervention rates unsterile wound irrigation is equal to sterile wound irrigation.ObjectiveThe primary aim of this study is therefore to investigate if there is a need for sterile wound irrigation after surgically drained spontaneous skin abscesses.MethodsIn a prospective, randomized controlled, single-blinded, single-center trial based on a noninferiority design, we will enroll 128 patients randomized to either the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a sterile wound irrigation performed by a home-care service twice a day. Patients randomized to the intervention group will be treated with a nonsterile wound irrigation (shower) twice a day. All patients will have a routine clinical control visit after 1, 3, 6, and 12 weeks in the outpatient clinic. Primary outcome is the reinfection and reoperation rate due to insufficient wound healing diagnosed either at the outpatient control visit or during general practitioner visits. Secondary outcome measures include a Short Form Health Survey, Visual Analog Scale, Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the EurolQol 5-Dimension Questionnaire. Those questionnaires will be completed at the outpatient control visits.ResultsThe trial was started in June 2016 and enrolled 50 patients by article publication. Regarding the adherence to our protocol, we found 10% of loss to follow-up until now. Only 2 patients needed reoperation and only 1 patient needed a change of treatment (antiseptic therapy). Most patients are happy with their randomized treatment but as expected some patients in the sterile group complained about timing problems with their working hours and home-care service appointments. Most patients in the nonsterile group are satisfied being able to take care of their wounds independently although some patients still depend on the home-care service for the wound dressing. We are hoping to have enrolled enough patients by summer 2017. The follow-up will take until autumn 2017, and study results are expected to be published by the end of 2017. This trial is solely supported by the cantonal hospital of Lucerne.ConclusionsNonsterile...
Background Soft tissue abscesses are among the most frequently encountered medical problems treated by different surgeons. Standard therapy remains incision and drainage with sterile saline irrigation during postoperative wound healing period. Aim of this prospective randomized controlled trial was to compare sterile irrigation versus nonsterile irrigation. Study design A single center randomized controlled trial was performed to investigate postoperative wound irrigation. The control group used sterile irrigation, and the intervention group used nonsterile irrigation. Primary endpoints were reinfection and reintervention rates, assessed during follow‐up controls for up to 2 years. Secondary endpoints were the duration of wound healing, inability to work, pain and quality of life. Results Between 04/2016 and 05/2017, 118 patients were randomized into two groups, with 61 allocated to the control‐ and 57 to the intervention group. Reinfection occurred in a total of 4 cases (6.6%) in the sterile protocol and 4 (7%) in the nonsterile protocol. Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams. Despite equal wound persistence rates, a substantially shorter amount of time off from work was reported in the nonsterile protocol group (p value 0.086). Conclusion This prospective, randomized trial indicates that a nonsterile irrigation protocol for patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol. Moreover, a nonsterile irrigation protocol leads to a shorter period of inability to work with comparable pain and quality of life scores during the wound healing period.
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