Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery

Not Applicable

Withdrawn

• Conditions: Wounds and Injuries
• Interventions: Other: Standard Care; Device: PICO Softport V1.6

• Registration Number: NCT02883010
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Study Start: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard Care	Gauze dressing, Film dressing, foam dressing, skin glue, no dressing
PICO	PICO Softport V1.6	Single use NPWT (PICO Softport V1.6)

Primary Outcome Measures

Name	Time	Method
Number of complications in each group	30 days

Secondary Outcome Measures

Name	Time	Method
To compare PICO against Standard Care for differences in Health Related Quality of Life (HRQoL) using SF-12 over the 14-day and 30-day follow-up period	30 days
Total number of readmissions during a 30-day follow-up period	30 days
Dehiscence incidence during a 30-day follow-up period	30 days
Total length of hospital stay, including readmissions during a 30-day follow-up period	30 days
Haematoma incidence during a 30-day follow-up period	30 days
Time to surgical incision closure	30 days
Time to initial discharge during a 30-day follow-up period	30 days
Seroma incidence during a 30-day follow-up	30 days
Overall per subject treatment cost for PICO and Standard Care	30 days
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period	30 days