Effectiveness of negative pressure wound dressing for wound healing after stoma closure: An open-label randomized control study

Background: Wound healing after stoma closure applying purse-string closure takes longer than after primary closure, although purse-string closure reduces wound infection rates. Application of negative pressure wound therapy may reduce the duration of wound healing. Objective and research questions: To compare wound healing periods with or without application of negative pressure wound therapy. Method: Design: A superiority, randomized controlled, open-label study. Inclusion/Exclusion criteria: Patients undergoing stoma closure will be included. Patients with allergic skin reactions to the dressing materials will be excluded. Primary and secondary outcome parameters: The primary outcome is the duration until complete wound healing. Secondary outcomes include wound infection rates, hospital stay, Patient and Observer Scar Assessment Scale. Group size calculation: The hypothesis is that applying negative pressure wound dressings reduces the duration of wound healing by 7 days. For a power of 80% and a level of significance of 5%, 36 patients will need to be included with an allocation ratio of 1:1. Time frame and funding: Data will be collected twice a week until 4 weeks postoperatively.