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

Summary

In a multi-institutional randomized noninferiority trial (n=112), primary linear closure with negative pressure wound therapy after ileostomy reversal achieved noninferior surgical site infection rates compared with pursestring closure, while markedly accelerating early wound healing. Scar appearance assessed by a validated scale was acceptable, and no device malfunctions occurred.

Key Findings

• Noninferior SSI rates with primary linear closure + NPWT versus pursestring (7% vs 2%; absolute difference 5% within a 16% noninferiority margin).
• Significantly faster early wound healing at 2 weeks (77% vs 23.5%; p<0.001); all wounds healed by 6 weeks in both groups.
• Scar appearance evaluated using the Patient and Observer Scar Assessment Scale was acceptable; no NPWT device malfunctions were reported.

Clinical Implications

Primary linear closure with NPWT can be considered a safe, convenient option that maintains SSI rates while expediting healing and offering acceptable scar outcomes after ileostomy reversal.

Limitations

• Nonblinded design may introduce assessment bias.
• Conducted at two institutions with a modest sample size, which may limit generalizability.

Future Directions

Larger multicenter trials with blinded outcome assessment and cost-effectiveness analyses should evaluate long-term scar quality and patient-reported outcomes.