Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing. Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing.
The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease: negative-pressure wound therapy versus standard open wound care after surgical excision.
Patients were randomly assigned to either negative-pressure wound therapy for 2 weeks or standard open wound healing. The primary end point of the study was the time to complete wound healing. Secondary end points were visual analog scale score, wound size ratio at day 14 (ie, wound healing rate), time to resume daily activities, and recurrence within 6 months after wound closure.
Forty-nine patients were included in the study: 24 patients were treated with vacuum therapy, and 25 patients underwent standard open wound care. Complete wound healing was achieved at a median of 84 days in the vacuum therapy group versus 93 days in control patients (p = 0.44). The wound size ratio was significantly lower in the vacuum therapy group (0.30 versus 0.57, p = 0.02), ie, higher wound healing rate in the first 2 weeks. There was no difference in visual analog scale scores and disease recurrence between both groups. The time to resume full daily activities after surgery was 27 days in the patients undergoing vacuum therapy and 29 days in the control patients (p = 0.92).
This study is limited by the small number of patients, the lack of blinding to patients and doctors, and the absence of patient quality-of-life evaluation.
It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease, and it has a positive effect on wound size reduction in the first 2 weeks. However, there is no difference in time to complete wound healing and time to resume daily life activities.
Sint Franciscus Gasthuis, Department of Surgery, Rotterdam, the Netherlands
Financial Disclosures: None reported.
Clinical Trial Registration: NL25724.101.08.
Correspondence: L. Ulas Biter, M.D., Sint Franciscus Gasthuis, Department of Surgery, PO Box 10900, 3004 BA Rotterdam, The Netherlands. E-mail: firstname.lastname@example.org