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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
PICO™ system (Smith\&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.
Humanitas Research Hospital
Rozzano, MI, Italy
RECRUITINGSurgical Site Infection (SSI) rate comparison
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
Time frame: Post-operative day 7
Surgical Site Infection (SSI) rate comparison
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
Time frame: Post-operative day 30
Wound healing timing comparison
Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
Time frame: Post-operative day 30
Quality of life assessment
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'.
Time frame: Post-operative day 7
Quality of life assessment
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'.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Post-operative day 30
Quality of life assessment
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'.
Time frame: Post-operative day 90
Quality of life assessment
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'.
Time frame: Post-operative day 180
Pain assessment
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).
Time frame: Post-operative day 7
Pain assessment
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).
Time frame: Post-operative day 30
Pain assessment
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).
Time frame: Post-operative day 90
Pain assessment
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).
Time frame: Post-operative day 180