Primary Linear Closure With Negative Pressure Wound Therapy Versus Pursestring Approximation After Ileostomy Reversal: A Randomized Noninferiority Trial

BACKGROUND: The optimal method of wound closure after ileostomy reversal remains uncertain. Pursestring approximation reduces surgical site infections but requires prolonged wound care. Combining negative pressure wound therapy with primary linear closure may offer a more convenient approach while maintaining acceptable infection rates. OBJECTIVE: To determine whether primary linear closure with negative pressure wound therapy is noninferior to pursestring approximation in preventing surgical site infection after ileostomy reversal. DESIGN: Prospective, non-blinded, multi-institutional, non-inferiority randomized controlled trial. SETTINGS: Community tertiary hospital and academic medical center. PATIENTS: Adults undergoing elective ileostomy reversal between October 2018 and March 2024. INTERVENTION: Participants were randomized to undergo either primary linear closure with negative pressure wound therapy or pursestring approximation for skin closure after ileostomy reversal. MAIN OUTCOME MEASURES: The primary outcome was the occurrence of surgical site infection, with a non-inferiority margin set at 16%. Secondary outcomes included time to wound healing and scar appearance using the validated Patient and Observer Scar Assessment Scale. RESULTS: One hundred twelve patients completed the study, with 61 in the negative pressure wound therapy arm and 51 in the pursestring approximation arm. Primary linear closure- negative pressure wound therapy was noninferior to pursestring approximation arm in terms of SSI: 7% and 2% respectively with an absolute risk difference of 5% (95% CI: 2.5% to 12.5%). Early wound healing at 2 weeks was achieved in 77% vs 23.5% of patients, respectively (p < 0.001, GEE analysis). All wounds healed by 6 weeks in both groups. No negative pressure wound therapy device malfunctions occurred. LIMITATIONS: Nonblinded study limited to 2 institutions. CONCLUSIONS: Ileostomy reversal by Primary linear closure- negative pressure wound therapy is noninferior to pursestring approximation in terms of the occurrence of surgical site infections while achieving significantly faster wound healing. The method is safe, convenient and cosmetically acceptable. (See Video Abstract)Trial Registration: Advocate Aurora Health IRB, IRB# 22.034 (7082).