Abstract
BackgroundAlthough the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of negative-pressure wound therapy (NPWT) can reduce the healing period for many types of wounds. Herein, we describe a planned trial to test the hypothesis that NPWT can reduce the healing period for PSC after stoma reversal.Methods/designPatients undergoing stoma reversal will be recruited and allocated into intervention and control groups, with 1:1 randomisation. Patients in the control group will receive standard postsurgical wound care; patients in the intervention group will receive NPWT using the PICO™ system. The target sample size will be 38 patients, as this will provide 80% power at the 5% level of significance to detect a 7-day reduction in the wound-healing period in the intervention group compared to that in the control group. The primary endpoint will be the duration to wound healing, defined as the time to nearly complete epithelisation of the wound, without any discharge or surgical site infection (SSI). Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores.DiscussionThe results of this planned randomised controlled study will clarify the role of NPWT in patients undergoing stoma reversal and strengthen the rationale for choosing a dressing technique.Trial registrationClinical Research Information Service (CRIS), KCT0004063. Registered on 6 June 2019.
Highlights
The wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced
The results of this planned randomised controlled study will clarify the role of negativepressure wound therapy (NPWT) in patients undergoing stoma reversal and strengthen the rationale for choosing a dressing technique
The primary objective of this Randomised controlled trial (RCT) will be to evaluate the application of NPWT to PSC after stoma reversal regarding its effectiveness in reducing the wound-healing period
Summary
The primary objective of this RCT will be to evaluate the application of NPWT to PSC after stoma reversal regarding its effectiveness in reducing the wound-healing period. Two additional studies evaluated the application of NPWT to ileostomy closure sites and demonstrated the efficacy of NPWT in reducing the SSI rate [17, 18] These previous studies focused on patients with primary linear closure of stoma wounds and did not evaluate the woundhealing period. The SR-PICO trial is a planned RCT to evaluate the efficacy of NPWT in reducing the woundhealing period in patients who undergo stoma closure using the PSC method.
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