Table 1.
Secondary outcome measures
| Secondary outcome | Measured by/using |
|---|---|
| Number of patients screened | Pre-Trial Screening Assessment Form |
| Number of patients eligible/ineligible | Pre-Trial Screening Assessment Form |
| Appropriateness of eligibility criteria and reasons for ineligibility | Pre-Trial Screening Assessment Form |
| Proportion of eligible patients consenting to participate (and whether type of wound/surgical speciality impacts on this) | Consent Form and Pre-Trial Screening Assessment Form |
| Time between randomisation and treatment start | Phase 1 Start of Treatment Form |
| Proportion of patients receiving randomised treatment within 48 h | Phase 1 Start of Treatment Form |
| Duration of Negative Pressure Wound Therapy (NPWT) | Phase 1 Start of Treatment Form and End of Phase 1 Treatment Form |
| Factors affecting timely delivery of randomised treatment | Non-immediate Use of NPWT Form |
| Wound dimensions | Assessment of Weekly Participant Events Form |
| Quality and completeness of data collected for date of healing | Assessment of Weekly Participant Events Form and Blinded Outcome Assessment Form |
| Patient-reported health-related quality of life | The Short Form (12) Health Survey (SF-12) [13] EuroQoL (EQ-5D) [14] |
| Cointerventions used and rate of treatment change | Investigator Baseline Case Report Form (CRF), Assessment of Weekly Participant Events Form, Phase 1 Start of Treatment Form, Phase 1 End of Treatment Form |
| Significant events (e.g. rehospitalisation, infection, reoperation) | Assessment of Weekly Participant Events Form |
| Adverse events | Adverse Event Form, Serious Adverse Event Form, Adverse Event/Serious Adverse Event Follow-up Form |
| Response rates | Proportion of participant self-report measures returned |
| Withdrawal rates | Change of Status Form |
| Treatment change including change from NPWT for intervention participants, reasons for changes and changes to NPWT | Surgical Wounds Dressing Change Form, End of Phase 1 Treatment Form and Assessment of Weekly Participant Events Form |
| Resource use | Resource Use Questionnaire (3-month Participant CRF) |
| Missing data rates | Missing responses |
| Healing rates | Assessment of Weekly Participant Events Form, Blinded Outcome Assessment Form |
| Blinded outcome assessment | Blinded Outcome Assessment Form |
| Participant opinion on trial participation | Likert Scales (3-month Participant CRF) |
| Self-reported wound pain | Weekly text messaging Visual Analogue Scales (baseline, 2-week, 1-month and 3-month Participant CRFs) Brief Pain Inventory (BPI) (baseline, 2-week, 1-month and 3-month Participant CRFs) [15] |
| Wound progress | Photographs Wound tracings Depth measurements |