Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

Not Applicable

• Conditions: Stoma Site Infection
• Interventions: Device: PICO™ 7

• Registration Number: NCT03781206
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.

Detailed Description

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith\&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-07-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18 years, any sex;
• Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
• Normal water contrast enema prior to surgery;
• Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
• Both immunosuppressant and biological medications are allowed for IBD patients.

Exclusion Criteria

• Patients age at screening < 18 years;
• Pregnant or breastfeeding women;
• Neurodegenerative disorders or psychiatric diseases;
• Contraindications or hypersensitivity to the use of the investigational product or its components;
• Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
• Patients with post-operative bleeding (to be assessed 24 hours after surgery).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy (NPWT)	PICO™ 7	PICO™ 7 will be applied after stoma reversal

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection (SSI) rate comparison	Post-operative day 30	The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination

Secondary Outcome Measures

Name	Time	Method
Wound healing timing comparison	Post-operative day 30	Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
Quality of life assessment	Post-operative day 180	Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Pain assessment	Post-operative day 180	Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy