Surgical wounds healing by secondary intention Surgery
Conditions
Interventions
Current intervention as of 01/04/2022:
Patients with a potential planned SWHSI (pre-operatively) or a SWHSI occurring at any point following surgery will be screened for potential eligibility by their
Sponsors
Hull University Teaching Hospital NHS Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or over 2. Has an acute SWHSI (i.e. a wound left open as planned following surgery or a wound initially closed using sutures, clips, or other closure methods and dehisced along the whole or part of its length, and of less than 6 weeks in duration), arising from any surgical specialty and occurring on any part of the body, deemed appropriate to receive either NPWT or wound dressing treatment 3. Has a SWHSI that is considered ready for NPWT treatment (i.e. contains at least 80% viable tissue or has only a very thin layer of slough requiring no further debridement) 4. Patient is not deemed to be malnourished, as per NICE guidelines CG 32 (BMI 10% in the last 3-6 months; BMI 5% in the last 3-6 months) or assessed as at high risk of malnutrition using the Malnutrition Universal Screening Tool (MUST) *Patients with weight loss arising either from underlying comorbidity (e.g. ulcerative colitis) or from the reasons for surgery being completed (e.g. bowel cancer) may be included at the clinician’s discretion 5. Willing and able to give informed consent and provide follow-up data
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 01/04/2022: 1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care 2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion 3. Inadequate haemostasis or patients who are at risk of bleeding 4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers)* *Note diabetic foot ulcers which have been incised and drained or debrided as an inpatient in theatre may be included given this constitutes a surgical wound. 5. Current wound has previously been, or is currently being, treated with NPWT 6. Planned delayed primary closure of the wound 7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the “open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver) 8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached Previous participant exclusion criteria: 1. Life expectancy of less than 6 months e.g. undergoing end stage palliative care 2. Active systemic infection (including osteomyelitis) at baseline as defined by clinical and/or laboratory assessment. Note: Patients who have an active infection, but are improving following 1 week’s duration of antibiotics may be included at the clinician’s discretion 3. Inadequate haemostasis or patients who are at risk of bleeding 4. Chronic wounds non-surgical in origin (e.g. pressure ulcers or foot ulcers) 5. Current wound has previously been, or is currently being, treated with NPWT 6. Planned delayed primary closure of the wound 7. Contraindication to NPWT including: presence of unclear undermining in the wound cavity; presence of necrotic tissue, malignant tissue or eschar; wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the “open abdomen” where the abdominal fascia is open); wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained; presence of a non-enteric or unexplored fistula; people requiring emergency airway aspiration, pleural mediastinal or chest tube drainage or surgical suction (removed 07/11/2019: people with a sensitivity or allergy to silver) 8. Currently participating in another wound research study, where the primary outcome time point has not yet been reached
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/11/2020: Time to healing in days from randomisation (defined using the commonly used and clinically certified criteria ‘complete epithelial cover in the absence of a scab (eschar)’). Confirmation of wound healing by a health care professional will initially be participant-reported through weekly telephone contact with the research nurse. Participants will be asked to report if their clinician or nurse has indicated that their wound is healed. In the event the participant reports their wound to be healed, but this has not been confirmed by a healthcare professional, the research nurse will contact the clinical care team to obtain this confirmation. Once wound healing has been confirmed by a healthcare professional and treatment has ceased, participants will undergo clinical assessments on three subsequent consecutive weeks. The first healing visit will be completed face to face wherever possible, during which standardised photographs will be taken of the wound for blinded outcome verification. We will also ask participants to take and return a photograph of the wound themselves. Study-specific instructions will be provided to the participant. The second and third post healing visits may be completed by telephone if required. _____ Previous primary outcome measure: Time to healing in days from randomisation (defined using the commonly used and clinically certified criteria ‘complete epithelial cover in the absence of a scab (eschar)’). Confirmation of wound healing by a health care professional will initially be participant-reported through weekly telephone contact with the research nurse. Participants will be asked to report if their clinician or nurse has indicated that their wound is healed. In the event the participant reports their wound to be healed, but this has not been confirmed by a healthcare professional, the research nurse will contact the clinical care team to obtain this confirmation. Once wound healing has | — |
Secondary
| Measure | Time frame |
|---|---|
| Current Secondary outcome measures as of 11/03/2024: 1. Clinical events including antibiotic treatment, hospital admission or discharge, treatment status (including reasons for dressing or treatment failure or change), re-operation (including skin grafting and closure surgery*), amputation and death will be assessed using clinic records and patient-reported events on a weekly basis until the point of wound healing. *The decision for closure surgery will be made blinded to treatment allocation as far as is possible 2. Wound infection assessed using the Bluebelle Wound Healing Questionnaire (WHQ). The questionnaire includes items to assess signs, symptoms and wound care interventions indicative of surgical site infection (SSI) and can be completed by patient self-report or by healthcare professionals. The tool may be used to assess wounds in hospital or after the patient has been discharged. The WHQ will be completed by the participants themselves at baseline, 3 month follow-up assessments, and will also be completed by the patient at the initial healing visit 3. Wound pain, assessed using a visual analogue scale (with anchors 0 ‘no pain’ and 10 ‘worst imaginable pain’). The scale will be completed by the participants themselves at baseline, 3, 6 and 12 month follow-up assessments 4. Quality of life, measured using the EQ-5D-5L at baseline, 3 months, 6 months and 12 months follow-up assessments 5. Resource use: wound-related NHS consultations, support (e.g. occupational therapy, in-home adaptions) and out-of-pocket costs collected using a patient-reported questionnaire at baseline, 3, 6 and 12 months Previous secondary outcome measures as of 01/04/2022: 1. Clinical events including antibiotic treatment, hospital admission or discharge, treatment status (including reasons for dressing or treatment failure or change), re-operation (including skin grafting and closure surgery*), amputation and death will be assessed using clinic records and patient-reported events on a | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactCatherine Arundel
Outcome results
None listed