Surgical Wounds Healing By Secondary Intention - 2

Not Applicable

Completed

• Conditions: Surgical wounds healing by secondary intention; Surgery

• Registration Number: ISRCTN26277546
• Lead Sponsor: Hull University Teaching Hospital NHS Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34696784/ (added 19/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Study Completion: 2024-01-31
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 686

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 <18.5 kg/m2; unplanned* weight loss >10% in the last 3-6 months; BMI <20kg/m2 and unplanned* weight loss >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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified