Negative Pressure Dressing Versus Conventional Passive Dressing in Pilonidal Surgery: A Randomized Controlled Trial.
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INTRODUCTION: Surgically treated pilonidal sinus disease (PSD) has high rates of postoperative wound complications, with surgical wound dehiscence (SWD) rates up to 44%. Negative pressure wound therapy (NPWT) is proposed to reduce rates of SWD for other high risk surgical wounds. Our aim was to investigate whether NPWT would reduce rates of SWD compared to conventional passive (CP) dressings for PSD excisions with off-midline primary closure. Our secondary outcomes included patient quality of life and time taken return to normal activities. METHOD: We performed a prospective, crossover pediatric/adult randomized controlled trial for patients (12-40 y) with PSD, requiring excision and off-midline primary closure. Participants were randomized to receive a CP (Primapore or Opsite) or NPWT (SNAP) dressing. Follow-up occurred on D3, D7, D10, D14 and then weekly until wound healing. Patients were sent a 2-month postoperative online survey to assess quality of life outcomes. RESULTS: Fifty patients were recruited, 25 to NPWT & 25 to CP. Mean age and body mass index were 22.6 ± 6.7 y and 26.1 ± 4.5 kg/m2, respectively. 36/50 (76%) were male. The overall dehiscence rate was 42% (21/50); 12/25 (48%) for NPWT & 9/25 (36%) for CP, P = 0.6. Five deep (≥5 mm) SWDs occurred in each group, P > 0.9. SWD was associated with increased excision dimensions in the NPWT group only, P = 0.03. Median duration to wound healing was equivalent in nondehisced wounds, (CP 21.0 [14.0-29.5] versus NPWT 21.0 [16.0-24.0] days, P = 0.7). There were no differences in mean time to the following: return to school/work (NPWT 26.1 ± 18.2 versus CP 29.3 ± 14.7 d, P = 0.6), sit normally (NPWT 22.3 ± 16.2 versus CP 20.1 ± 9.4 d, P = 0.7), or return to physical activity (NPWT21.6 ± 17.2 versus CP40.3 ± 2.4 d, P = 0.2). CONCLUSIONS: NPWT did not improve outcomes after excision of PSD with off-midline primary closure. Despite the limited population size, our results do not support its use as a routine preventative measure.