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

NCT02883010 | Withdrawn

• 1 other identifier: CT1602PIC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wounds and Injuries

Keywords

Surgical incision; surgical complication; NPWT; negative pressure; colorectal surgery; dehisced

Outcome Measures

Primary Outcomes (1)

• Number of complications in each group

  30 days

Secondary Outcomes (10)

• 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

Study Arms (2)

PICO

EXPERIMENTAL

Single use NPWT (PICO Softport V1.6)

Device: PICO Softport V1.6

Standard care

OTHER

Gauze dressing, Film dressing, foam dressing, skin glue, no dressing

Other: Standard Care

Interventions

PICO Softport V1.6 DEVICE

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.

PICO

Standard Care OTHER

Care path normally used by the hospital

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject or legal guardian must provide written informed consent (reference section 9.1).
• Subjects eighteen (18) years of age or older.
• Willing and able to make all required study visits.
• Able to follow instructions.
• Males or females.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Subjects with skin features (e.g., tattoos, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
• Subjects who have participated previously in this clinical trial.
• 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.
• Subjects with incisions exceeding 40 cm in length.
• Subjects with incisions that are actively bleeding unless homeostasis has been achieved (to be confirmed during surgery).
• Patients attending for a re-operation within the last 3 months.
• Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
• Patients with a systemic infection (that is not related to perforated bowel or peritonitis) at the time of surgery.
• Patients with a known history of poor compliance with medical treatment.
• Patients who also have a gynaecological procedure carried out during the colorectal procedure.
• 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.
• Patients with a genetic or acquired healing defect.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Beate Hanson, MD, PhD

  Vice President, Global Clinical Strategy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share