Effect of Gentamicin-absorbed Collagen in Wound Healing in Pilonidal Sinus Surgery: a Prospective Randomized Study

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1 The Journal of International Medical Research 2010; 38: Effect of Gentamicin-absorbed Collagen in Wound Healing in Pilonidal Sinus Surgery: a Prospective Randomized Study I YETIM 1, OV OZKAN 1, A DERVIŞOGLU 2, K ERZURUMLU 3 AND E CANBOLANT 1 ¹Department of General Surgery, Mustafa Kemal University Medical Faculty, Antakya- Hatay, Turkey; ²Department of General Surgery, Medicalpark Private Hospital, Istanbul, Turkey; ³Department of General Surgery, Ondokuz Mayis University (OMU) Medical Faculty, Samsun, Turkey Pilonidal sinus is a common disease that causes the loss of many working hours, but treatment is variable and problematic. The effect of gentamicin-absorbed collagen on healing, infection and recurrence, and length of hospital stay were examined after pilonidal sinus surgery. Patients undergoing surgical treatment for pilonidal sinus were randomly assigned into two groups each of 40 patients. Both groups were treated with excision and primary closure under local anaesthesia. Group 1 (control) received oral antibiotics for 7 days post-operatively. In group 2, prior to wound closure, gentamicin-absorbed collagen sponges were placed on the sacral fascia and these patients did not receive oral post-operative antibiotic therapy. Patients in group 2 had a significantly shorter mean wound healing time, significantly lower infection and recurrence rates, and a significantly shorter hospital stay than those in group 1. It is concluded that implantation of a gentamicin-containing collagen sponge on the wound area in pilonidal sinus decreased the rates of infection and recurrence, and shortened the hospital stay. KEY WORDS: GENTAMICIN-ABSORBED COLLAGEN; ANTIBIOTICS; PILONIDAL SURGERY; POST-OPERATIVE WOUND HEALING; LENGTH OF HOSPITAL STAY Introduction Pilonidal sinus is a common disease that causes a substantial loss of working hours. It occurs in 26 per people, predominantly young adults, and affects males twice as often as females. 1 The management of chronic pilonidal disease is variable, contentious and problematic, however the principles of treatment require eradication of the sinus tract, complete healing of the overlying skin and prevention of recurrence. Controversy persists regarding the optimal management for adolescent pilonidal disease and the surgical approach to symptomatic pilonidal sinus is open to debate. Many techniques have been described but none fulfils the requirements of an ideal treatment, 2 8 however ambulatory treatment with minimal morbidity and rapid return to activity is desirable. 9 The major disadvantage of open wound treatment is the long healing time. Primary wound closure is, on the other hand, often followed by infection. Previous studies have looked at the effects 1029

2 of a gentamicin-containing collagen sponge on healing and wound infections The aim of the present study was to analyse the effect of this treatment on healing and postoperative complications in patients undergoing pilonidal sinus surgery. Patients and methods PATIENTS All patients with pilonidal sinus who attended the Samsun Nafız Kurt Bafra Hospital and Department of General Surgery at Mustafa Kemal University Medical Faculty, between January 2007 and May 2009, and satisfied the criteria for daysurgery anaesthesia, assessed by a single consultant were recruited to this study. The study was approved by the Ethics Committee of Mustafa Kemal University Medical Faculty and written consent for their participation was obtained from all the patients. STUDY DESIGN AND SURGICAL PROCEDURE Patients were randomly assigned to two groups in consecutive order of attendance at the clinic: group 1 (control) had sinus excision and primary closure performed under local anaesthesia; and group 2 also had sinus excision and primary closure performed under local anaesthesia but, before closure, cm gentamicincontaining collagen sponges (Gentacoll ; Schering-Plough A/S, Farum, Denmark) comprising collagen from equine tendons (70 mg) and gentamicin sulphate (50 mg) were placed on the sacral fascia (Fig. 1). In both groups the wound was infiltrated with 0.5% bupivacaine with 1: adrenaline and closed with interrupted 0 polyglactin sutures to subcutaneous fat and tension free 2/0 prolene sutures to the skin. Patients in group 1 received a 1 g/day oral quinolone (ciprofoxacin) and ornidazole combination for 7 days, while those in group 2 did not receive post-operative antibiotic therapy. Patients were followedup 15 days, 1, 3, 6 and 12 months after surgery. Stitches were removed in the outpatient clinic after days and the FIGURE 1: Implantation of the gentamicin-containing collagen sponge after excision of pilonidal sinus 1030

3 wound was assessed. Short- and long-term complications, recurrences and wound infections were recorded. STATISTICAL ANALYSIS The mean ± SD was calculated for the data. The duration of wound healing was analysed using the Mann Whitney U-test, and differences in recurrence and wound infection were analysed by the χ 2 -test. Results A total of 82 patients were assessed for inclusion in the study. Two patients were excluded because the histology was not consistent with the diagnosis of pilonidal sinus. This left a total of 80 patients: 40 in group 1 (control) and 40 in group 2. There were no significant differences between the groups in terms of history and duration of disease (group 1, 1.2 ± 0.8 years; group 2, 1.3 ± 0.6 years), or in wound size (group 1, 5.3 ± 0.9 cm; group 2, 5.4 ± 0.6 cm). Patients in group 2 had a significantly shorter wound healing time (P = 0.001) and hospital stay (P = 0.001), and significantly lower post-operative wound infection (P = 0.001) and recurrence rates (P = 0.001) than patients in group 1 (control) (Table 1). Discussion In this randomized study of pilonidal sinus surgery, the use of gentamicin-containing collagen sponges decreased the rate of postoperative infection and recurrence, and shortened healing time and these effects are comparable with previous studies. 15,16 Holzer et al. 15 compared primary closure plus the use of a gentamicin-containing collagen fleece after open surgery and found the time to healing significantly longer in the group where the fleece was not used. Primary wound healing was successful in 73% of patients receiving the gentamicincontaining collagen fleece. Wound breakdown was caused either by seroma formation or by spontaneous dehiscence, which subsequently healed. 15 The use of systemic antibiotic therapy in the control group in the current study did not compensate for the lack of local antibiotic use. This suggests that surgical excision of the pilonidal sinus in combination with insertion of a resorbable antibiotic sponge is to be recommended. Serum levels of gentamicin were not measured in the present study since it has been previously demonstrated that they are markedly lower with local application than those achieved by systemic therapy. 12 Gentacoll is a biologically absorbable collagen sponge, that enables the local application of gentamicin in an abscess cavity. It is produced from sterilized, treated equine tendons into which gentamicin is suspended and is absorbed by the body over TABLE 1: Post-operative wound infection and recurrence, healing time and length of hospital stay following pilonidal sinus surgery without (group 1) or with (group 2) use of a gentamicincontaining collagen sponge Wound healing Hospital stay, Wound infection Recurrence time, mean ± SD mean ± SD (n) (n) (days) (days) Group 1 (n = 40) ± ± 0.8 Group 2 (n = 40) ± ± 0.6 P-value (group 1 vs 2)

4 a period of approximately 8 weeks. The collagen in its ingredients provides effective haemostasis. Over 40 clinical studies have evaluated the performance of using a gentamicin-containing collagen sponge, either for treating localized infection or for preventing surgical site infections, across a wide variety of surgical procedures. For example, one published clinical trial of 2000 patients undergoing open heart surgery by median sternotomy showed that implantation of a gentamicin-containing collagen sponge reduced the frequency of post-operative sternal wound infections by > 50% compared with systemic antibiotics alone. 17 Randomized studies of prophylaxis with local collagen gentamicin have reported a reduction of surgical site infections in dirty abdominal surgery and in prosthetic repair of groin hernias. 7 In spite of favourable findings on the cost effectiveness and efficacy of collagen gentamicin in a range of surgery types, its use in pilonidal sinus surgery has not become routine. The results of this study indicate that the implantation of a gentamicin containing collagen sponge on the wound area in pilonidal sinus decreased the rate of infection, recurrence and shortened the hospital stay. We suggest that this procedure should be used routinely in pilonidal sinus surgery. Conflicts of interest The authors had no conflicts of interest to declare in relation to this article. Received for publication 30 November 2009 Accepted subject to revision 7 December 2009 Revised accepted 12 March 2010 Copyright 2010 Field House Publishing LLP References 1 Sondenaa K, Andersen E, Nesvik I, et al: Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis 1995; 10: Allen-Mersh TG: Pilonidal sinus: finding the right track for treatment. Br J Surg 1990; 77: Spivak H, Brooks VL, Nussbaum M, et al: Treatment of chronic pilonidal disease. Dis Colon Rectum 1996; 39: Søndenaa K, Anderson E, Søreide JA: Morbidity and short term results in a randomised trial of open compared to closed treatment of chronic pilonidal sinus. Eur J Surg 1992; 158: Chintapatla S, Safarani N, Kumar S, et al: Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol 2003; 7: Aydede H, Erhan Y, Sakarya A, et al: Comparison of three methods in surgical treatment of pilonidal disease. Aust NZ J Surg 2001; 71: Khaira HS, Brown JH: Excision and primary suture of pilonidal sinus. Ann R Coll Surg Engl 1995; 77: Iesalnieks I, Fürst A, Rentsch M, et al: Primary midline closure after excision of a pilonidal sinus is associated with a high recurrence rate. Chirurg 2003; 74: [in German]. 9 Abdul-Ghani AK, Abdul-Ghani AN, Ingham Clark CL: Day-care surgery for pilonidal sinus. Ann R Coll Surg Engl 2006; 88: Gado FJ: Effectiveness of collagen-gentamicin implant for treatment of dirty abdominal wounds. World J Surg 1999; 23: Rutten HJ, Nijhuis PH: Prevention of wound infection in elective colorectal surgery by local application of a gentamicin containing collagen sponge. Eur J Surg Suppl 1997; 578: Rosen HR, Marczell AP, Czerwenka E, et al: Local gentamicin application for perineal wound healing following abdominoperineal rectum excision. Am J Surg 1991; 162: Gruessner U, Clemens M, Pahlplatz PV, et al: Improvement of perineal wound healing by local administration of gentamicinimpregnated collagen fleeces after abdominoperineal excision of rectal cancer. Am J Surg 2001; 182: Musella M, Guido A, Musella S: Collagen tampons as aminoglycoside carriers to reduce postoperative infection rate in prosthetic repair of groin hernias. Eur J Surg 2001; 167: Holzer B, Grüssner U, Brückner B, et al: Efficacy and tolerance of a new gentamicin collagen fleece (Septocoll ) after surgical treatment of a pilonidal sinus. Colorectal Dis 2003; 5:

5 16 Vogel P, Lenz J: Treatment of pilonidal sinus with excision and primary suture using a local, resorbable antibiotic carrier. Results of a prospective randomized study. Chirurg 1992; 63: [in German]. 17 Friberg O, Svedjeholm R, Söderquist B, et al: Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg 2005; 79: Author s address for correspondence Dr İbrahim Yetim Department of General Surgery, Mustafa Kemal University Medical Faculty, Antakya-Hatay, Turkey. yetim54@gmail.com 1033