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Novel Approach of Treatment of Pilonidal Sinus Disease With Thrombin Gelatin Matrix as a Sealant

Elbanna, Hosam G. M.D.; Emile, Sameh Hany M.D.; Youssef, Mohamed M.D.; Thabet, Waleed M.D.; El-Hamed, Tito M. Abd M.D.; Ghnnam, Wagih M. M.D.

Diseases of the Colon & Rectum: August 2016 - Volume 59 - Issue 8 - p 775–780
doi: 10.1097/DCR.0000000000000604
Original Contributions: Anorectal Disease

BACKGROUND: Sacrococcygeal pilonidal sinus disease is a condition caused by insertion of fallen hair shafts into the skin. Different types of operations have been described for the management of pilonidal sinus, yet none of them have proven to be superior to the others. Recently, sealants like fibrin glue have been successfully used.

OBJECTIVE: This study aimed to assess the efficacy of thrombin gelatin matrix as a new sealant for pilonidal sinus treatment.

DESIGN: This was a prospective study conducted from March 2013 to March 2015.

SETTINGS: The study was conducted in private hospitals in Mansoura City.

PATIENTS: The study included 36 male patients (72%) and 14 female patients (28%), with a median age of 22 years.

INTERVENTIONS: Fifty patients with pilonidal sinus were admitted and treated with thrombin gelatin matrix injection.

MAIN OUTCOME MEASURES: Incidence and time of pilonidal sinus recurrence, postoperative pain and complications, duration of hospital stay, healing status, and time to return to work were recorded.

RESULTS: The median duration of symptoms was 13 months, median operative time was 18 minutes, and median hospital stay was 6 hours. All of the procedures were conducted as day-case surgeries. Median follow-up duration was 24 months. Three patients (6%) had a breakdown of the sealant, and the wound was managed with daily dressings. Recurrence at 1 year was observed in 2 patients (4%). A total of 96% of patients were satisfied with the outcome of the procedure, and 92% of patients resumed their daily activities within 3 days.

LIMITATIONS: Follow-up for a longer duration is required to ascertain the efficacy of this new technique. The cost of this treatment might be challenging for resource-limited communities.

CONCLUSIONS: Management of pilonidal sinus using thrombin gelatin matrix, despite being expensive, is an effective, simple treatment that is easy to perform and associated with low recurrence rate, minimal morbidity, and rapid recovery.

General Surgery Department, Faculty of Medicine, Mansoura University Hospitals, Mansoura City, Egypt

Financial Disclosure: None reported.

Correspondence: Sameh Hany Emile, M.D., General Surgery Department, Faculty of Medicine, Mansoura University Hospitals, Elgomhuoria Street, Mansoura City, Egypt. E-mail: sameh200@hotmail.com

Mayo was the first to describe pilonidal sinus (PS) disease in 1833 as a hair-containing cyst deeply situated below the coccyx.1 PS is a common condition affecting mainly the sacrococcygeal region in the midline natal cleft. It is more common in young male subjects, with a male:female ratio of 3:1.2

Pathogenesis of PS is still not fully understood. The most accepted theory suggests that fallen hairs from the scalp or local hairs penetrate into the subcutaneous tissues through dilated hair follicles causing a localized foreign body reaction resulting in the formation of a cyst and subsequently an abscess.3 Clinically, PS presents with serosanguinous discharge, dull aching pain at the sacrococcygeal area, or with more acute presentation in the form of an abscess.4

Ideal management of PS should be simple, attaining acceptable recurrence rates with the least possible tissue trauma. Surgery was thought to be the most successful treatment for chronic PS disease with regard to prevention of postoperative recurrence, which is estimated to be ≈8% according to a recent meta-analysis.5 However, alternative treatment options, like tissue sealants, have achieved comparable recurrence rates6 but without prolonged recovery time and significant morbidity associated with excisional and flap surgeries. That is why injection of various materials through the PS tract was devised to achieve a shorter hospital stay, minimal postoperative morbidity, and better cosmetic results.7

Injection of 80% phenol in the PS tract was one of the early attempts to treat this condition.8 A newer medical therapy that is applied after simple curetting of the sinus tract is fibrin glue, which is applied to each individual tract after curettage.8,9 Fibrin glue injection therapy achieved satisfactory results, with recurrence rates ranging between 0% and 17% according to a recent review.6

In the current study, we aimed to evaluate the efficacy of thrombin gelatin matrix as a new sealant in the management of PS disease with regard to the incidence of recurrence of PS after surgery, postoperative complications including wound infection, and patient satisfaction. The rationale of using thrombin gelatin matrix injection was to avoid morbidities and prolonged recovery time associated with conventional excisional or flap surgeries and to test thrombin gelatin as an alternative to fibrin glue, because the latter is not widely available in its commercial form in Egypt. Manually prepared or “homemade” fibrin sealants have questionable safety and quality, because they might not reconstitute properly, leading to high rates of infection and recurrence; thus, thrombin gelatin matrix appeared to be a viable alternative.

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PATIENTS AND METHODS

Study Design and Ethical Approval

Fifty patients with PS were admitted to private hospitals in Mansoura City, including Mansoura Military Hospital, and were enrolled in this prospective study between March 2013 and March 2015. The study was conducted after approval of the institutional review board of the Mansoura University Hospitals Faculty of Medicine [code R/15.10.54] and was registered at www.clinicaltrials.gov (NCT02638064). Those studied included 36 male patients (72%) and 14 female patients (28%), with a median age of 22 years (range, 14–45 years).

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Selection of Patients

Patients included in the study had PS with single or multiple tracts. Those with recurrent cases of PS after previous surgery were also included in the study. We excluded patients unfit for anesthesia, patients with severe scarring at the natal cleft attributed to previous surgery or infection, and patients with signs of acute abscess or history of drainage of abscess <6 months ago.

Thirty-four patients (68%) had a single PS opening, whereas 16 patients (32%) had more than 1 sinus opening. The majority of patients (80%) had midline PS, whereas 20% of patients had midline sinus associated with 1 or more lateral extensions.

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Preoperative Assessment

Patients were interviewed by a resident who took a detailed history regarding the current symptom, duration of symptoms, previous treatments, past history of infection or abscess drainage, and associated comorbidities. Laboratory investigations in the form of blood picture, liver and kidney function tests, and prothrombin time were performed to assess the anesthetic fitness of the patients. Written informed consents were obtained from all of the patients after explaining the nature and complications of the procedure.

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Operative Technique

Patients were operated on under spinal anesthesia in the prone position. Cefotaxime (1 g) was given intravenously as antibiotic prophylaxis at induction. All of the procedures were performed by a single surgeon.

After shaving hairs at the sacrococcygeal region, povidone iodine antiseptic was used to scrub the skin. The depth of the natal cleft was measured, and then probing and curettage of the sinus was performed using a special serrated needle (Fig. 1) until there was complete removal of the sinus contents, including hairs and unhealthy granulation tissues. All of the debris was carefully extracted from the sinus to avoid acute infection induced by any remaining hairs or granulation tissues. Curettage was carried out until fresh bleeding was encountered from the sinus opening, and then repeated irrigation with sterile saline/gentamycin solution was performed (Fig. 2). Pressure on the natal cleft was applied to evacuate any remaining saline solution in the sinus.

FIGURE 1

FIGURE 1

FIGURE 2

FIGURE 2

In case of PS with multiple openings, all of the sinus openings were closed with nonabsorbable sutures (polyprolene 3/0) except for the most distal opening, through which thrombin gelatin matrix (Surgiflo, Johnson & Johnson Wound Management, Somerville, NJ) was injected. In the case of PS with a single opening, thrombin gelatin matrix was injected and then the opening was carefully trimmed and closed.Thrombin gelatin matrix was mixed with saline and applied with a special injector into the PS without any compression applied to the sinus. Thrombin gelatin matrix was injected (Fig. 3) during withdrawal of the injector until it overflowed (Fig. 4) from the sinus opening, and then the injector was removed while applying constant pressure on the area for 60 seconds. After closure of the sinus opening (Fig. 5), a compressive dressing was applied to the area for 24 hours.

FIGURE 3

FIGURE 3

FIGURE 4

FIGURE 4

FIGURE 5

FIGURE 5

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Postoperative Care and Instructions

Patients were kept under observation for 6 hours after the procedure to record postoperative pain, analgesic consumption, and early complications. Patients were then discharged on prophylactic oral antibiotics (500 mg of ciprofloxacin every 12 hours) and simple analgesics for 3 to 5 days postoperatively. Patients were advised to follow strict personal hygiene, with regular removal of hairs at the gluteal and sacrococcygeal regions either by special hair removal creams or by laser epilation, which was considered the better choice. Stitches were removed when complete healing was ascertained, at 5 to 7 days after the procedure.

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Follow-up

Follow-up was scheduled in the outpatient clinic on a weekly basis in the first postoperative month and then on a monthly basis for 1 year after the procedure. Pain at the site of procedure, status of healing, recurrence and its timing, return to work and normal activities, and postoperative morbidities were queried and recorded. For assessment of postoperative pain, visual analog scale grading from 0 to 10 was used, where 0 means no pain and 10 represents maximum tolerable pain. A questionnaire about patient satisfaction was completed by patients at 3 months postoperatively. A surgical resident who was unaware of the nature of the study conducted the questionnaire and primary evaluation of patients before the surgeon, and one of the authors evaluated the patient.

Primary outcome assessed was the incidence of recurrence of PS within 1 year of follow-up. Recurrence was defined as the presence of any persisting purulent/bloody discharge at the operative site or nearby area. Secondary outcomes included postoperative complications as wound infection, postoperative pain, time to resume daily activities and return to work, and patient satisfaction.

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Statistical Analysis

Data were analyzed using Microsoft Excel (Microsoft, Redmond, WA) and SPSS version 21 (IBM SPSS Statistics for Windows, Armonk, NY). Quantitative data were expressed as median and range.

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RESULTS

This study included 50 patients with sacrococcygeal PS disease. Participants included 36 male patients (72%) and 14 female patients (28%). Median age of the patients was 22 years (range, 14–45 years) and median BMI was 26.4 (range, 23.2–33.2). Five patients (10%) had a positive family history with a first-degree relative.

Thirty-three patients (66%), who were all males, had abundant coarse body hair. Forty-seven patients (94%) had primary PS, and 3 patients (6%) had recurrent PS after previous surgeries. Twenty-four patients (48%) had underwent incision and drainage of abscess at the natal cleft >6 months before the procedure. Thirty-eight patients (76%) had a complaint of serosanguinous discharge, whereas 42 patients (84%) complained of dull aching pain at the sacrococcygeal region that was increased by prolonged sitting. The median duration of symptoms was 13 months (range, 4–28 months). Demographic and symptom data of patients are shown in Table 1.

TABLE 1

TABLE 1

Median depth of the natal cleft was 3.5 cm (range, 3.0–5.0 cm). Median operative time was 18 minutes (range, 15–35 minutes). Median hospital stay was 6 hours (range, 4–8 hours). Patients were discharged from the hospital on the same day of surgery. The median period of follow-up was 24 months (range, 6–30 months). Forty-seven patients (94%) achieved primary healing within 2 weeks, whereas 3 patients (6%) had breakdown of sealant and were managed by daily dressing of the wound until complete healing occurred.

Neither major postoperative morbidities nor mortality was recorded. We detected minor complications such as mild pain (visual analog scale, 1–3) at the operative site in 26 patients (52%) and wound infection in 1 patient (2%), which was managed conservatively by antibiotics. Recurrence of PS was reported in 2 patients (4%), who were both males. The ultimate success rate for the technique was 96.00% (95% CI, 95.43–96.56). Median duration required for resumption of daily activities and return to work was 2 days. Results of the patient satisfaction questionnaire are displayed in Table 2.

TABLE 2

TABLE 2

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DISCUSSION

Optimal treatment of PS should not be only effective but also simple, attaining quick recovery and resumption of normal activities10; hence, scientists started searching for more conservative methods for the management of PS. Armstrong and Barcia11 reported good results following a conservative treatment plan that was composed of proper hair control by shaving the natal cleft, improving perineal hygiene, and performing a limited lateral incision.

The idea of injection of certain materials inside the PS to induce sclerosis followed by obliteration of the sinus is not new. In 1989, Kelly and Graham12 used 80% phenol injection in the treatment of PS in 54 patients, achieving a success rate of 70% with a median hospital stay of 2 days. A recent study on 143 patients with PS concluded that the recurrence rate after phenol injection was 8.3% after following patients for a mean period of 24 months.13 Phenol injection accompanied by regular application of hair removal cream achieved satisfactory results in cases of recurrent chronic PS, with recurrence rates ranging between 0% and 11%.14

Fibrin glue was proposed in 1992 as a sealant material for the treatment of PS when Vitale et al15 described filling the resultant cavity after excision of sacrococcygeal PS with fibrin glue. Fibrin glue could be used alone or in combination with excisional surgery. Excision can be of the skin and subcutaneous tissue16 or of the sinus epithelium.17 Moreover, fibrin glue can be used in combination with flap surgery as a Limberg flap.18

Fibrin glue is composed of 2 components, highly purified human fibrinogen with factor XIII and a solution containing human thrombin. Mixing both components leads to formation of a blood clot simulating the final stage of coagulation cascade. Fibrin monomers assemble into a stronger cross-linked fibrin polymer with the aid of thrombin, which activates factor XIII, thereby facilitating the bonding of fibrin polymer.19

Isik et al7 were the first to use fibrin glue as a standalone therapy for PS without excision. They used a stylet for curettage of the sinus to clear any hairs or granulation tissues before injection of fibrin glue to eliminate dead space. The authors described the procedure as a simple, noninvasive technique that can be performed under local anesthesia. They reported an acceptable recurrence rate of 10%, comparable to recurrence rates of complicated procedures, such as the Limberg flap and Karydakis procedure, but without postoperative complications, delayed recovery, and disfiguring scars associated with surgery.

More studies investigated the efficacy of fibrin glue in the treatment of PS. One study reported that 74% of patients required no further treatment after injection of fibrin glue, and 79% were satisfied, pleased, or very pleased with the results of their procedure.10 A systematic review of the role of fibrin glue in the treatment of PS reported recurrence rates ranging between 0% and 17% at follow-up periods between 4 and 28 months.6

Smith et al20 reported their early experience with fibrin glue in a study of 41 children with a median age of 15 years. The authors compared fibrin glue injection with lateralizing flap procedures. Overall recurrence rates of fibrin glue injection were comparable to lateralizing flap procedures (17% versus 21%).

Othman21 evaluated the effect of N-butyl-2 cyanoacrylate (Histoacryl-TissueSeal, B. Braun Corporation, Ann Arbor, MI) as a tissue sealant following the excision of PS. The author reported good results, with a recurrence rate of 5% and delayed wound healing in 15% of patients, with no recorded cases of wound infection.

Despite the encouraging results of using tissue sealants in the treatment of PS, the current evidence is based on small cohort studies with relatively short follow-up. According to the practice parameters devised by The American Society of Colon and Rectal Surgeons, tissue sealants are to be used for selected cases of PS with a weak grade of recommendation (C2), whereas operative management has a stronger grade (1B). Perhaps future randomized controlled trials comparing both modalities would add more evidence supporting the use of tissue sealants as the first line treatment of PS.22

In our study we used thrombin gelatin matrix for the treatment of PS, whether it was primary disease or recurrent after previous surgery. The concept of treatment using thrombin gelatin matrix is similar to that of fibrin glue. Blood platelets adhere and aggregate within the gelatin matrix, thus initiating the natural coagulation cascade. Endogenous thrombin is activated, and then it converts patient fibrinogen into an insoluble fibrin clot. Based on this mechanism of action, we used thrombin gelatin matrix to induce such a hemostatic effect inside the cavity of PS.

Meticulous curettage of the sinus cavity is mandatory for 2 reasons. The first reason is to clear the sinus cavity from hairs, granulation tissues, and debris to prevent possible infection. The second reason is to create a raw bleeding surface inside the sinus cavity, thus when thrombin gelatin matrix is applied it will initiate the hemostatic cascade aforementioned, ending with an insoluble fibrin clot filling the dead space. The fibrin clot is then organized by the body to form a fibrous plug, obliterating the sinus cavity and preventing any future hair entrapment and thus a recurrence of PS.

In most of the studies that evaluated the role of fibrin glue in the treatment of PS, fibrin glue injection was used as an adjunct for excisional or flap surgeries, not as a sole procedure, except in 2 trials6,8 where fibrin glue was injected after curettage of the sinus, similar to the technique that we followed in the current study.

The recurrence rate of PS after thrombin gelatin injection (4%) is lower than recurrence rates after fibrin glue injection, which varied from 0% when it was combined with surgery to 17% when it was used a sole procedure, according to a recent systematic review.6 The median duration of hospital stay after thrombin gelatin injection was 6.0 hours, less than that of fibrin glue injection, which was 7.5 hours. The time for complete healing after fibrin glue injection varied from 11 to 42 days, whereas 94% of patients in our study showed complete healing within 2 weeks.

Our study proved that thrombin gelatin matrix can be used as an alternative for fibrin glue injection in cases of PS because it can be used as a standalone technique without the need for associated surgical intervention yielding lower recurrence rates when used alone, thus, it can achieve better results without the need for simultaneous surgical interventions. Furthermore, our inclusion criteria expanded to include PS with more than 1 tract and recurrent PS, whereas most of the studies evaluating fibrin glue injection had restricted the inclusion criteria to primary nonrecurrent PS with only 1 tract; this renders thrombin gelatin matrix a valid alternative for a wide spectrum of patients with PS.

Patients in our study were mostly young males, as seen in the literature.2 All of the patients had primary PS, except for 3 patients who had recurrent disease. The procedure was characterized by a short operative time and brief hospital stay. Healing was complete within 2 weeks in >90% of patients. Two patients, who were both male subjects with a BMI >30, had recurrence in the form of a single sinus opening in the midline; 1 was a recurrent case after previous surgery and was detected at the fourth postoperative month. The other case was a primary PS, and recurrence was detected at month 7 after injection. Recurrence could be attributed to incomplete clearance of the sinus cavity from all debris or to insufficient injection of thrombin gelatin matrix. One case of recurrence was managed by reinjection of thrombin gelatin matrix, and the other patient was managed by surgical excision of PS, because he refused another trial of injection. No recurrence was detected in either patient after 6 months of follow-up.

Limitations of this study include the short-term follow-up necessitating additional trials with longer follow-up duration to ascertain the efficacy of this new technique. High cost associated with this treatment (average cost of the procedure is 350$ versus $250 to $300 for excisional or flap surgeries) might be a challenging issue for resource-limited communities. Finally, the single-surgeon element may affect the outcome when the technique is reproduced by other surgeons. A randomized controlled trial comparing this technique with surgical excision and fibrin glue injection would help to verify the potential benefits of thrombin gelatin matrix injection and to draw firm conclusions about its efficacy.

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CONCLUSION

Thrombin gelatin matrix is an effective hemostatic agent that can be used beyond its original indication. It can be considered a promising treatment option for PS disease, because it has a low recurrence rate, short operative time, brief hospital stay, minimal morbidity rate, and high patient satisfaction.

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ACKNOWLEDGMENT

The authors thank Drs Ahmed Youssef, Mohamed Fouda, and Mohamed El-Hosary, the surgical residents of the hospitals in which this work was done, for their active participation in following the patients and conducting questionnaires, which significantly contributed to the present study.

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REFERENCES

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Keywords:

Pilonidal sinus; Sealant; Thrombin gelatin

© 2016 The American Society of Colon and Rectal Surgeons