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A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection.

ABSTRACT: A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT.

SUBMITTER: Totty JP

PROVIDER: S-EPMC6850133 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe National Surgical Quality Improvement Program logs surgical site infections (SSIs) as the most common cause of unplanned postoperative readmission for a variety of surgical interventions. Hospitals are making significant efforts preoperatively and postoperatively to reduce SSIs and improve care. Telemedicine, defined as using remote technology to implement health care, has the potential to improve outcomes across a wide range of parameters, including reducing SSIs.ObjectiveThe purpose of this study was to assess the feasibility and user satisfaction of two automated messaging systems, EpxDecolonization and EpxWound, to improve perioperative care in a quality improvement project for patients undergoing total joint replacement.MethodsWe designed two automated text messaging and calling systems named EpxDecolonization, which reminded patients of their preoperative decolonization protocol, and EpxWound, which monitored pain, wound, and fever status postoperatively. Daily patient responses were recorded and a post-usage survey was sent out to participants to assess satisfaction with the systems.ResultsOver the 40-week study period, 638 and 642 patients were enrolled in EpxDecolonization (a preoperative decolonization reminder) and EpxWound (a postoperative surgical site infection telemonitoring system), respectively. Patients could be enrolled in either or both EpxDecolonization and EpxWound, with the default option being dual enrollment. The proportion of sessions responded to was 85.2% for EpxDecolonization and 78.4% for EpxWound. Of the 1280 patients prescribed EpxWound and EpxDecolonization, 821 (64.14%) fully completed the postoperative system satisfaction survey. The median survey score (scale 1-9) was 9 for patient-rated overall care and 8 for whether the telemonitoring systems improved patient communication with providers. The majority of patients (69.0%, 566/821) indicated that the systems sent out an ideal number of messages (not too many, not too few).ConclusionsEpxDecolonization and EpxWound demonstrated high response rates and improved patient-rated communication with providers. These preliminary data suggest that these systems are well tolerated and potentially beneficial to both patients and providers. The systems have the potential to improve both patient satisfaction scores and compliance with preoperative protocols and postoperative wound monitoring. Future efforts will focus on testing the sensitivity and specificity of alerts generated by each system and on demonstrating the ability of these systems to improve clinical quality metrics with more authoritative data.

Project description:Women presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction. These outcomes after RFM are related to smaller fetal size on ultrasound scan, oligohydramnios and lower human placental lactogen (hPL) in maternal serum. We performed this study to address whether a randomised controlled trial (RCT) of the management of RFM was feasible with regard to: i) maternal recruitment and retention ii) patient acceptability, iii) adherence to protocol. Additionally, we aimed to confirm the prevalence of poor perinatal outcomes defined as: stillbirth, birthweight <10th centile, umbilical arterial pH <7.1 or unexpected admission to the neonatal intensive care unit.Women with RFM ?36 weeks gestation were invited to participate in a RCT comparing standard management (ultrasound scan if indicated, induction of labour (IOL) based on consultant decision) with intensive management (ultrasound scan, maternal serum hPL, IOL if either result was abnormal). Anxiety was assessed by state-trait anxiety index (STAI) before and after investigations for RFM. Rates of protocol compliance and IOL for RFM were calculated. Participant views were assessed by questionnaires.137 women were approached, 120 (88%) participated, 60 in each group, 2 women in the standard group did not complete the study. 20% of participants had a poor perinatal outcome. All women in the intensive group had ultrasound assessment of fetal size and liquor volume vs. 97% in the standard group. 50% of the intensive group had IOL for abnormal scan or low hPL after RFM vs. 26% of controls (p?<?0.01). STAI reduced for all women after investigations, but this reduction was greater in the standard group (p?=?0.02). Participants had positive views about their involvement in the study.An RCT of management of RFM is feasible with a low rate of attrition. Investigations decrease maternal anxiety. Participants in the intensive group were more likely to have IOL for RFM. Further work is required to determine the likely level of intervention in the standard care arm in multiple centres, to develop additional placental biomarkers and to confirm that the composite outcome is valid.ISRCTN07944306.

Project description:BackgroundSurgical site infections (SSIs) are common, occurring in up to 25% of?>?4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered.Methods/designThis study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial.DiscussionThis pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed.Trial registrationISRCTN49328913 . Registered on 20 October 2015.

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A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection.

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