The Bluebelle pilot trial: Is it possible to recruit participants to a trial of different methods of dressing surgical wounds, one of which is to use no dressing?

Conditions

Surgical site infections Surgery Surgical site infections

Barnaby C Reeves, Leila Rooshenas, Rhiannon Macefield, Mark Woodward, Nicky J. Welton et al. (65 authors)

Health Technology Assessment2019-08-0113 citations

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial.

Bluebelle Study Group, Reeves BC, Andronis L, Blazeby JM, Blencowe NS, Calvert M, Coast J, Draycott T, Donovan JL, Gooberman-Hill R, Longman RJ, Magill L, Mathers JM, Pinkney TD, Rogers CA, Rooshenas L, Torrance A, Welton NJ, Woodward M, Ashton K, Bera KD, Clayton GL, Culliford LA, Dumville JC, Elliott D, Ellis L, Gould-Brown H, Macefield RC, McMullan C, Pope C, Siassakos D, Strong S, Talbot H.

2017-08-2911 citations

10.1186/s13063-017-2102-5

Interventions

Participants, confirmed as having provided consent and as eligible for the study, will be randomised via a secure web-based database. Participants will be randomised to one of six groups, comprising a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 16 years or over 2. Patients undergoing primary elective or unplanned abdominal general surgery (including, but not limited to gastrectomy for benign or malignant disease, cholecystectomy, anti-reflux procedures, hepatic resection, small or large bowel resection for benign or malignant conditions, abdominal wall hernia surgery (inguinal, femoral, incisional, epigastric and paraumbilical)) or elective or unplanned obstetric surgery (caesarean section). (NB Potential participants undergoing simultaneous abdominal and chest surgery are eligible but only the abdominal wounds will be included in the study interventions) 3. The wound is intended to be closed at the end of the procedure with sutures or clips 4. The potential participant is willing to attend follow-up for 4-8 weeks

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone abdominal or other major surgery less than three months before the index operation 2. Patients who have allergies to dressings or other contraindication to dressings 3. Patients undergoing groin surgery 4. Patients undergoing surgery which result in only internal wounds (e.g. intra vaginal surgery) 5. Prisoners and adults lacking capacity to consent 6. Ability to read/understand English

Design outcomes

Primary

Measure	Time frame
To establish whether recruitment into the main trial is possible, by recording the number of patients screened, eligible and randomised into the pilot trial.	—

Secondary

Measure	Time frame
1. Health status is measured using the EQ-5D-5L will be collected at baseline, day 15, 4-8 weeks and between these time points if a participant considers that there is a problem with the wound(s) 2. Participant symptom experience is measured using the Wound Experience Questionnaire will be completed within 48 hours of discharge 3. Practical wound management is measured using the Wound Management Questionnaire will be completed by a nurse up to 24 hours before discharge if the participant is an inpatient or up to 48 hours after discharge if the participant is a day case 4. Surgical site infection post discharge is measured using the Wound Healing (SSI) questionnaire will be completed by the participant and a member of the research team at the 4-8 week assessment. A member of the research team will also complete a reference SSI assessment at the 4-8 week assessment. 5. Qualitative research will be carried out alongside the trial to investigate facilitators and barriers to recruitment and possible reasons for non-adherence	—

Measure

Time frame

1. Health status is measured using the EQ-5D-5L will be collected at baseline, day 15, 4-8 weeks and between these time points if a participant considers that there is a problem with the wound(s) 2. Participant symptom experience is measured using the Wound Experience Questionnaire will be completed within 48 hours of discharge 3. Practical wound management is measured using the Wound Management Questionnaire will be completed by a nurse up to 24 hours before discharge if the participant is an inpatient or up to 48 hours after discharge if the participant is a day case 4. Surgical site infection post discharge is measured using the Wound Healing (SSI) questionnaire will be completed by the participant and a member of the research team at the 4-8 week assessment. A member of the research team will also complete a reference SSI assessment at the 4-8 week assessment. 5. Qualitative research will be carried out alongside the trial to investigate facilitators and barriers to recruitment and possible reasons for non-adherence

—

Countries

England, United Kingdom

Contacts

Public ContactJane Blazeby

Outcome results

None listed