BACKGROUND: Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp(®)) in reducing the wound infection rate and recurrencesafter excision of pilonidal sinus and wound closure with primary midline suture. METHODS: From March 2003 to November 2005, 161 patients with symptomatic pilonidal disease were operated on at 11 hospitals with traditional wide excision of the sinus and all of its tracts. The patients were randomized to filling of the cavity with a gentamicin-containing collagen sponge (Collatamp(®)) before wound closure or to closure with no additional treatment. Information about the treatment allocation was hidden until the end of the study. Information about wound healing was noted at follow-up at the outpatient department after 2-4 days, 2 weeks, 3 months, and 1 year. RESULTS: No statistically significant differences were observed between the groups during follow-up. Patients who received prophylaxis with Collatamp(®) had slightly fewer wounds with exudate at 2-4 days and 2 weeks of follow-up (2% vs. 10%, p = 0.051 and 57% vs. 65%, p = 0.325, respectively), a slightly larger proportion of healed wounds at 3 months follow-up (77% vs. 66%, p = 0.138) but not at 1 year (85% vs. 90%, p = 0.42, respectively), and slightly more reoperations (10% vs. 4%, p = 0.213). CONCLUSIONS: This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin-collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin-collagen sponge for the surgical treatment of pilonidal disease.
RCT Entities:
BACKGROUND: Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp(®)) in reducing the wound infection rate and recurrences after excision of pilonidal sinus and wound closure with primary midline suture. METHODS: From March 2003 to November 2005, 161 patients with symptomatic pilonidal disease were operated on at 11 hospitals with traditional wide excision of the sinus and all of its tracts. The patients were randomized to filling of the cavity with a gentamicin-containing collagen sponge (Collatamp(®)) before wound closure or to closure with no additional treatment. Information about the treatment allocation was hidden until the end of the study. Information about wound healing was noted at follow-up at the outpatient department after 2-4 days, 2 weeks, 3 months, and 1 year. RESULTS: No statistically significant differences were observed between the groups during follow-up. Patients who received prophylaxis with Collatamp(®) had slightly fewer wounds with exudate at 2-4 days and 2 weeks of follow-up (2% vs. 10%, p = 0.051 and 57% vs. 65%, p = 0.325, respectively), a slightly larger proportion of healed wounds at 3 months follow-up (77% vs. 66%, p = 0.138) but not at 1 year (85% vs. 90%, p = 0.42, respectively), and slightly more reoperations (10% vs. 4%, p = 0.213). CONCLUSIONS: This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin-collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin-collagen sponge for the surgical treatment of pilonidal disease.
Authors: M N Mavros; P K Mitsikostas; V G Alexiou; G Peppas; M E Falagas Journal: Eur J Clin Microbiol Infect Dis Date: 2013-02-05 Impact factor: 3.267
Authors: F Ravanetti; R Chiesa; M C Ossiprandi; F Gazza; V Farina; F M Martini; R Di Lecce; G Gnudi; C Della Valle; J Gavini; A Cacchioli Journal: J Mater Sci Mater Med Date: 2016-01-19 Impact factor: 3.896
Authors: Michelle B Formanek; Loreen A Herwaldt; Eli N Perencevich; Marin L Schweizer Journal: Surg Infect (Larchmt) Date: 2014-04-28 Impact factor: 2.150