Exploring feedback from research nurses in relation to the design and conduct of a randomised controlled trial of wound care treatments: A sequential, dependent, mixed-methods study.

BACKGROUND: Research nurse involvement in trials is crucial to successful conduct, however their feedback on trial design and conduct is not necessarily always collected and shared. This study was designed to explore research nurse feedback in relation to study and protocol design and implementation in the National Institute for Health Research Programme Grants for Applied Research funded Surgical Wounds Healing by Secondary Intention pilot and feasibility trial (SWHSI). The primary aim of this study was to inform the design and conduct of a proposed future, larger study in this area. Given the evidence gap, it was deemed prudent to share these findings for the benefit of others. METHODS: A sequential, dependent mixed methods study, comprising a Likert scale questionnaire and semi-structured interviews, explored the experiences, in relation to study design and conduct, of research nurses involved in the trial. Of the 10 research nurses involved in the trial, eight nurses completed a questionnaire and were interviewed. Questionnaire data was analysed using descriptive statistics and interview data using thematic analysis. RESULTS: A range of questionnaire responses were provided, however at least 50% (n = 4) of respondents indicated that they were happy with both the study design and conduct. Interview data identified key themes to consider when involving research nurses in the design, delivery and conduct of RCTs; removing barriers to recruitment, time management, engagement strategies and resource provision. CONCLUSION: Engagement of research nurses is important to enable effective trial conduct. Research teams should therefore consider how best to obtain and include input from all members of the research team from the outset. Furthermore, the sharing of feedback on research design and conduct, from the perspective of research nurses delivering trial recruitment and retention, remains crucial to effective and efficient trial conduct. TRIAL REGISTRATION: Clinical Trial Registry: ISRCTN12761776. Date of registration: 10th December 2015.

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial.

BACKGROUND: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT. METHODS: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months. DISCUSSION: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. TRIAL REGISTRATION: Clinical Trial Registry: ISRCTN12761776 , registered on 10 December 2015 - retrospective registration.

Anaerobic co-digestion of mechanically biologically treated municipal waste with primary sewage sludge - a feasibility study.

This bench scale study investigated the suitability of MBT material for treatment by anaerobic digestion and the impacts of co-digestion of these wastes with sewage sludge. The results suggest that MBT material is amenable to anaerobic digestion with sewage sludge. The main problems for scale-up are related to the physical composition of the MBT material, the accumulation of heavy metals and other inert contaminants and the impact of both of these factors on final sludge quality. Full-scale trials would be required to assess the long-term impacts of MBT waste on anaerobic digestion, if this form of co-digestion were to be pursued. The material contamination that presents a barrier to the direct recycling of MBT material in land-applications is also a major hurdle in commercial co-digestion. Better quality input material would be likely to result in higher methane yields and fewer restrictions on the utilisation of the product in recycling.