Background
Stoma-reversal surgery is associated with high postoperative morbidity, including wound complications and surgical-site infections (SSIs). This study aims to assess whether the application of negative-pressure wound therapy (NPWT) can improve wound healing compared with conventional wound dressing.
Methods
This was a single-centre, superiority, open-label, parallel, individually randomized controlled trial. Patients undergoing stoma reversal were randomized (1 : 1) to receive NPWT or conventional wound dressing. The primary endpoint of the study was the rate of wound complications and SSIs after stoma closure. The secondary endpoints were postoperative wound pain, rate of wound healing after 30 days from stoma closure, and wound aesthetic satisfaction.
Results
Between June 2019 and January 2021, 50 patients were allocated to the NPWT group (all received NPWT, 49 were analysed); 50 patients were allocated to the conventional wound dressing group (48 received the treatment, 45 were analysed). No significant difference was found in wound-complication rate (10 per cent NPWT versus 16 per cent controls; odds ratio 0.61 (95 per cent c.i. 0.18 to 2.10), P = 0.542) and incisional SSI rate (8 per cent NPWT versus 7 per cent controls; odds ratio 1.24 (95 per cent c.i. 0.26 to 5.99), P = 1.000). The NPWT group showed less pain, higher aesthetic satisfaction (P < 0.0001), and a higher proportion of wound healing (92 versus 78 per cent; P = 0.081) compared with the control group.
Conclusion
NPWT does not reduce the incidence of SSI after stoma-reversal surgery compared with conventional wound dressing. However, NPWT improved the healing of uninfected wounds, reduced wound pain and led to better aesthetic outcomes.
Registration number: NCT037812016 (clinicaltrials.gov).
Crohn's disease (CD) is a chronic relapsing inflammatory bowel disease with unknown etiology. Up to 80% of patients will eventually require surgery throughout their lifetime, and often repeated resections are required for disease recurrence. Observations of “creeping fat” surrounding the diseased intestine renewed interest in the mesentery, recently defined as an organ with endocrine and immune functions. According to the inside-out model, the mesentery may be primarily affected in CD and subsequent cause alterations in the mucosa. Recently, lower surgical recurrence rates have been reported with en-bloc excision of the mesentery adjoining the diseased intestine. Results of ongoing randomized controlled trials may clarify the role of the mesentery in CD and possibly lead to its adoption as standard during surgery for Crohn's disease.
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