scholarly journals Efficacy of a dual-ring wound protector for prevention of incisional surgical site infection after Whipple's procedure (pancreaticoduodenectomy) with preoperatively-placed intrabiliary stents: protocol for a randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (8) ◽  
pp. e005577-e005577 ◽  
Author(s):  
A. K. Bressan ◽  
D. J. Roberts ◽  
J. P. Edwards ◽  
S. U. Bhatti ◽  
E. Dixon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Surgical Site Infection ◽  
Controlled Trial ◽  
Site Infection ◽  
Wound Protector ◽  
Incisional Surgical Site Infection ◽  
Whipple’S Procedure ◽  
Randomised Controlled ◽  
Dual Ring

scholarly journals Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e029620 ◽  
Author(s):  
Kenneth A McLean ◽  
Katie E Mountain ◽  
Catherine A Shaw ◽  
Thomas M Drake ◽  
Riinu Ots ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Surgical Site Infection ◽  
Postoperative Care ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Site Infection ◽  
Wound Assessment ◽  
Time To Diagnosis ◽  
Randomised Controlled

IntroductionNational data suggest that surgical site infection (SSI) complicates 2%–10% of general surgery cases, although the patient-reported incidence is much higher. SSIs cause significant patient morbidity and represent a significant burden on acute healthcare services, in a cohort predominantly suitable for outpatient management. Over three-quarters of UK adults now own smartphones, which could be harnessed to improve access to care. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment.Methods and analysisThis is a randomised controlled trial aiming to recruit 500 patients across National Health Service (NHS) hospitals. All emergency abdominal surgery patients over the age of 16 who own smartphones will be considered eligible, with the exclusion of those with significant visual impairment. Participants will be randomised in a 1:1 ratio between standard postoperative care and the intervention – use of the smartphone tool in addition to standard postoperative care. The main outcome measure will be time-to-diagnosis of SSI with secondary outcome measures considering use of emergency department and general practitioner services and patient experience. Follow-up will be conducted by clinicians blinded to group allocation. Analysis of time-to-diagnosis will be by comparison of means using an independent two sample t-test.Ethics and disseminationThis is the first randomised controlled trial on the use of a smartphone-delivered wound assessment tool to facilitate the assessment of SSI and the impact on time-to-diagnosis. The intervention is being used in addition to standard postoperative care. The study design and protocol were reviewed and approved by Southeast Scotland Research and Ethics Committee (REC Ref: 16/SS/0072 24/05/2016). Study findings will be presented at academic conferences, published in peer-reviewed journals and are expected in 2020. A written lay summary will be available to study participants on request.Trial registration numberNCT02704897; Pre-results.

scholarly journals Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030615 ◽  
Author(s):  
Jane Blazeby
Keyword(s):  
Randomised Controlled Trial ◽  
Surgical Site Infection ◽  
Wound Closure ◽  
Controlled Trial ◽  
Response Rates ◽  
Secondary Outcome ◽  
Site Infection ◽  
Main Trial ◽  
Surgical Wounds ◽  
Randomised Controlled

ObjectiveSurgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.DesignA pilot, factorial RCT.SettingFive UK hospitals.ParticipantsAdults undergoing abdominal surgery with a primary surgical wound.InterventionsParticipants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure).Primary and secondary outcome measuresFeasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L).ResultsBetween March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks.ConclusionsA definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.Trial registration number49328913; Pre-results.

scholarly journals Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034687
Author(s):  
Ri Na Yoo ◽  
Hyung Jin Kim ◽  
Jae Im Lee ◽  
Won-Kyung Kang ◽  
Bong-Hyeon Kye ◽  
...  
Keyword(s):  
Informed Consent ◽  
Abdominal Surgery ◽  
Surgical Site Infection ◽  
Study Participant ◽  
Dropout Rate ◽  
Site Infection ◽  
Wound Protector ◽  
Open Abdominal Surgery ◽  
Randomised Controlled ◽  
Dual Ring

IntroductionSurgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery.Methods and analysisThe circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms—one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study.Ethics and disseminationThe trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences.Trial registration numberNCT 03170843.

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