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

A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: PICO Softport V1.6; Other: Standard Care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

1. The subject or legal guardian must provide written informed consent (reference section 9.1).
2. Subjects eighteen (18) years of age or older.
3. Willing and able to make all required study visits.
4. Able to follow instructions.
5. Males or females.
6. Subject must be classified as a high risk patient in terms of likelihood for SSC's (i.e., heavy smoker (more than 20 cigarettes per day), diabetic, BMI ≥ 30, immunocompromised) or be treated as an emergency patient with obstructed bowel, perforated bowel or peritonitis and be undergoing any of the following procedures:- Left hemicolectomy, right hemicolectomy, extended right hemicolectomy, sigmoidectomy, anterior rectum resection, total colectomy.

EXCLUSION CRITERIA

1. Contraindications or hypersensitivity to the use of the investigational product or its components (e.g., silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing.
2. Subjects with extremely fragile skin who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
3. Participation in another clinical trial (with use of investigational medicinal product or medical device) within thirty (30) days of Visit 1 or during the study.
4. Subjects with skin features (e.g., tattoos, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
5. Subjects who have participated previously in this clinical trial.
6. Subjects with a reference incision (that is the largest incision that is made during the surgery and the one that is allocated to study treatment) less than 8cm.
7. Subjects with incisions exceeding 40 cm in length.
8. Subjects with incisions that are actively bleeding unless homeostasis has been achieved (to be confirmed during surgery).
9. Patients attending for a re-operation within the last 3 months.
10. Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
11. Patients with a systemic infection (that is not related to perforated bowel or peritonitis) at the time of surgery.
12. Patients with a known history of poor compliance with medical treatment.
13. Patients who also have a gynaecological procedure carried out during the colorectal procedure.
14. Patients other than those with a disease known to affect the immune system that are on steroids or other immune modulators known to impact healing.
15. Patients with a genetic or acquired healing defect.
16. Exposure of blood vessels, organs, bone or tendon within the incision (to be confirmed during surgery).
17. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO; Single use NPWT (PICO Softport V1.6)	Device: PICO Softport V1.6; PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 2 weeks.
Other: Standard care; Gauze dressing, Film dressing, foam dressing, skin glue, no dressing	Other: Standard Care; Care path normally used by the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of complications in each group	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Dehiscence incidence during a 30-day follow-up period	30 days
Haematoma incidence during a 30-day follow-up period	30 days
Seroma incidence during a 30-day follow-up	30 days
Time to surgical incision closure	30 days
Total length of hospital stay, including readmissions during a 30-day follow-up period	30 days
Time to initial discharge during a 30-day follow-up period	30 days
Total number of readmissions during a 30-day follow-up period	30 days
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
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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: colorectal surgery; negative pressure; NPWT; surgical complication; Surgical incision; dehisced
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CT1602PIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO