ORIGINAL CONTRIBUTION
The Use of Negative-Pressure Wound Therapy in Pilonidal Sinus Disease: A Randomized Controlled Trial Comparing Negative-Pressure Wound Therapy Versus Standard Open Wound Care After Surgical Excision L. Ulas Biter, M.D. • Guyon M. N. Beck, M.D. • Guido H. H. Mannaerts, M.D., Ph.D. Myrte M. Stok, M.D. • Arie C. van der Ham, M.D., Ph.D. Brechtje A. Grotenhuis, M.D., Ph.D. Sint Franciscus Gasthuis, Department of Surgery, Rotterdam, the Netherlands
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: Forty-nine patients were included in the study: 24 patients were treated with vacuum therapy, and 25 patients underwent standard open wound care. Complete 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: [email protected] Dis Colon Rectum 2014; 57: 1406–1411 DOI: 10.1097/DCR.0000000000000240 © The ASCRS 2014
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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). LIMITATIONS: 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. CONCLUSION: 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. KEY WORDS: Pilonidal sinus disease; Vacuum therapy; Negative pressure wound therapy; Wound care; Wound size reduction; Surgical excision.
P
ilonidal sinus is a disease that most commonly arises in the hair follicles of the natal cleft of the sacrococcygeal area.1 Pilonidal sinus disease is a potentially morbid condition, because the disease and its treatment may cause significant discomfort, pain, immobility, and burdensome wound care, resulting in time lost from work or school.2,3 The treatment of pilonidal disease consists of surgical excision (definitive treatment requires eradication Diseases of the Colon & Rectum Volume 57: 12 (2014)
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Diseases of the Colon & Rectum Volume 57: 12 (2014)
of the entire sinus tract), healing of the overlying skin, and the prevention of recurrence. There are many options for the surgical management of pilonidal disease; options range widely from a simple excision with or without primary closure to complex flap reconstructions. Over the past decade, studies focused predominantly on the question of whether to close the wound or to leave it open for secondary healing.4 Primary closure is thought to be more convenient for patients compared with an open wound healing. Systematic reviews on this topic have been performed to determine the relative effects of primary closure compared with healing by secondary intention (open healing) for pilonidal sinus disease.4,5 It has been demonstrated that primary closure leads to faster healing rates and a more rapid return to work, but at the expense of an increased risk for recurrence.4,5 Recurrent pilonidal disease after initial wound closure was less frequent after healing by secondary intention; a 58% lower recurrence risk than after primary closure was calculated.4 Much effort has been spent on developing new procedures to accelerate wound healing. Negative-pressure wound therapy (NPWT) was developed two decades ago and consists of an open-cell foam dressing covered with an adhesive drape. The dressing is connected to a vacuum pump that creates a subatmospheric pressure of –50 to –125 mm Hg, which can be applied constantly or intermittently. Negative-pressure wound therapy drains wound exudate and is thought to promote blood circulation and to improve wound healing.6 The best known variant is the vacuum-assisted closure system.7 With regard to the treatment of pilonidal disease, it is not surprising that open wounds take longer than closed wounds to heal, but a longer healing time also reflects other outcome parameters such as the length of hospital stay and the time to return to work. Therefore, it has been suggested in recent case studies that NPWT, as the primary treatment following wide excision of pilonidal sinus disease, could shorten the duration of wound healing and time to resume daily activities.8–12 However, no large case series or randomized studies on this subject have been reported in recent literature. The purpose of the current study was to evaluate NPWT after complete surgical excision of the pilonidal sinus. We conducted a randomized controlled trial to compare NPWT with standard open wound healing with regard to its efficacy and patients’ comfort.
MATERIALS AND METHODS Patients
All patients requiring surgical treatment for a pilonidal sinus at our hospital between October 2009 and May 2012 were evaluated for inclusion in the current trial. The indication for surgery was either a symptomatic pilonidal sinus with or without a previous abscess of the sinus. Exclusion criteria for participation were age younger than
16 years, a previous attempt at surgical excision of pilonidal disease, and the inability to undergo frequent follow-up. Moreover, patients in whom the pilonidal sinus was situated less than 3 cm from the anus were also not considered for inclusion, because the NPWT device could not be placed into position locally. Patients were requested to sign the informed consent form before random assignment, and were given an information prospect of the study. Randomization took place 1 day before the scheduled operation to facilitate the presence of a NPWT device in the operating room when required. The randomization process was conducted by the principal investigator of the study by using a computer-generated randomization list without any restrictions such as block size. Study Protocol
Before the start of the study, the local medical ethics committee had approved the study protocol. Patients were randomly assigned at the outpatient clinic to undergo NPWT (device was applied directly after surgical excision) for 14 days, or to undergo standard open wound care. It was evaluated whether it was feasible to apply NPWT in the pilonidal sinus region, ie, whether the position of the NPWT device would hinder its use in a correct way. The primary end point of the study was time to complete wound healing, defined as the number of days until full skin closure was achieved. Secondary end points were the wound size ratio at postoperative day 14 (wound size at postoperative day 14 (T1) divided by wound size at postoperative day 0 (T0), ie, wound healing rate after 14 days), the visual analog scale score at postoperative day 14, time to resume daily activities such as work or school (patient’s self-report), and recurrence of the pilonidal sinus within 6 months after closure of the wound. Surgery
The same surgical technique was applied in all patients. Surgical excision was performed under spinal anesthesia with the patient in the prone jackknife position (Fig. 1). The fistula was probed by using a blunt needle. Methylene blue was injected to define the exact borders of the cyst. An elliptical incision of the skin was made around the pilonidal sinus. Surgical diathermy was used for further complete excision of the cyst, if necessary, up to the level of the os coccygis (Fig. 2). After excision of the pilonidal sinus and removal of the tape used for patient positioning (Fig. 1), the length, width, and height of the wound (all in centimeters) were measured in the operating room and documented. When hemostasis was obtained, a porous silicone wound dressing was left in the wound in all patients. In the postoperative phase, all patients were advised to take paracetamol on a regular daily basis (1000 mg 4 times a day) and an additional nonsteroidal anti-inflammatory drug when needed.
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at the first application of the sponge to minimize postoperative pain caused by negative pressure on the periost of the os coccygis; it was removed at the first outpatient appointment. During follow-up, the sponge was replaced at postoperative days 3, 7, and 10 at the outpatient clinic. At day 14, NPWT was finished, and regular wound care was started: patients were advised to rinse the wound 3 times daily until a superficial wound was achieved; hereafter, the rinsing frequency was reduced. Standard Open Wound Healing
FIGURE 1. Patient with pilonidal sinus disease after positioning in the operating room (jackknife position).
Negative-Pressure Wound Therapy
If the patient was randomly assigned to NPWT, the vacuum-assisted closure device was placed directly by an experienced surgeon or wound care nurse in the operating room after surgical excision. First, a sponge was positioned in the wound on top of the surrounding skin. A topical skin adhesive (Dermabond) was applied to the borders to prevent skin damage. The NPWT device (consisting of an open-pore foam covered by an adhesive semipermeable dressing) was applied and connected to a special medical vacuum (Fig. 3). A negative pressure of 125 mm Hg was adjusted to the wound 24 hours a day. In the NPWT group, the porous silicone wound dressing was only placed
In the control group, the wound was left open after surgical excision. A silicone wound dressing was applied with an absorbent bandage on top. Patients were advised to rinse the wound 3 times daily during the first 2 weeks after excision. No special dressings were applied, unless the wound appeared sloughy and/or retention of pus was noted. Follow-up
Follow-up consisted of a predetermined schedule for all patients at the outpatient clinic. Inspection was done by a surgeon together with a wound care nurse. Each patient returned to the hospital at postoperative days 3, 7, 10, and 14 for wound inspection. Wound size, complications (such as infection [defined as pain and redness of the wound], abscess [defined as retention of pus in the wound], and bleeding), and pain score (measured by the visual analog scale score) were documented. After 2 weeks, all patients visited the outpatient clinic on a weekly basis for inspection and wound measurement until the wound was closed completely. Six months after wound closure, there was 1 final check for the recurrence of pilonidal sinus disease. Statistical Evaluation
Before the start of this study, no sample size calculation had been performed. The available literature on using NPWT in patients who have pilonidal sinus is scarce, making a valid calculation impossible. Data were prospectively
FIGURE 2. Wound after complete excision of the pilonidal sinus.
FIGURE 3. The NPWT device is applied on the wound after excision of the pilonidal sinus. NPWT = negative-pressure wound therapy.
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Diseases of the Colon & Rectum Volume 57: 12 (2014)
TABLE 1. Patient characteristics
Sex, male/female Age, ya Smoking (current smokers), n (%) Diabetes mellitus, n (%) Previous abscess, n (%)
TABLE 2. Results
NPWT (N = 24)
Control (N = 25)
18/6 23 (16–44) 6 (25)
23/2 29 (16–65) 6 (24)
1 (4) 10 (42)
1 (4) 12 (48)
NPWT = negative-pressure wound therapy. a Median value with its range presented within parentheses.
collected and stored in a database. Data analysis was performed in SPSS version 17.0 (SPSS, Chicago, IL). Statistical analysis appropriate for nonparametric data was used. Two-sided p values of
The Use of Negative-Pressure Wound Therapy in Pilonidal Sinus Disease: A Randomized Controlled Trial Comparing Negative-Pressure Wound Therapy Versus Standard Open Wound Care After Surgical Excision L. Ulas Biter, M.D. • Guyon M. N. Beck, M.D. • Guido H. H. Mannaerts, M.D., Ph.D. Myrte M. Stok, M.D. • Arie C. van der Ham, M.D., Ph.D. Brechtje A. Grotenhuis, M.D., Ph.D. Sint Franciscus Gasthuis, Department of Surgery, Rotterdam, the Netherlands
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: Forty-nine patients were included in the study: 24 patients were treated with vacuum therapy, and 25 patients underwent standard open wound care. Complete 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: [email protected] Dis Colon Rectum 2014; 57: 1406–1411 DOI: 10.1097/DCR.0000000000000240 © The ASCRS 2014
1406
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). LIMITATIONS: 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. CONCLUSION: 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. KEY WORDS: Pilonidal sinus disease; Vacuum therapy; Negative pressure wound therapy; Wound care; Wound size reduction; Surgical excision.
P
ilonidal sinus is a disease that most commonly arises in the hair follicles of the natal cleft of the sacrococcygeal area.1 Pilonidal sinus disease is a potentially morbid condition, because the disease and its treatment may cause significant discomfort, pain, immobility, and burdensome wound care, resulting in time lost from work or school.2,3 The treatment of pilonidal disease consists of surgical excision (definitive treatment requires eradication Diseases of the Colon & Rectum Volume 57: 12 (2014)
1407
Diseases of the Colon & Rectum Volume 57: 12 (2014)
of the entire sinus tract), healing of the overlying skin, and the prevention of recurrence. There are many options for the surgical management of pilonidal disease; options range widely from a simple excision with or without primary closure to complex flap reconstructions. Over the past decade, studies focused predominantly on the question of whether to close the wound or to leave it open for secondary healing.4 Primary closure is thought to be more convenient for patients compared with an open wound healing. Systematic reviews on this topic have been performed to determine the relative effects of primary closure compared with healing by secondary intention (open healing) for pilonidal sinus disease.4,5 It has been demonstrated that primary closure leads to faster healing rates and a more rapid return to work, but at the expense of an increased risk for recurrence.4,5 Recurrent pilonidal disease after initial wound closure was less frequent after healing by secondary intention; a 58% lower recurrence risk than after primary closure was calculated.4 Much effort has been spent on developing new procedures to accelerate wound healing. Negative-pressure wound therapy (NPWT) was developed two decades ago and consists of an open-cell foam dressing covered with an adhesive drape. The dressing is connected to a vacuum pump that creates a subatmospheric pressure of –50 to –125 mm Hg, which can be applied constantly or intermittently. Negative-pressure wound therapy drains wound exudate and is thought to promote blood circulation and to improve wound healing.6 The best known variant is the vacuum-assisted closure system.7 With regard to the treatment of pilonidal disease, it is not surprising that open wounds take longer than closed wounds to heal, but a longer healing time also reflects other outcome parameters such as the length of hospital stay and the time to return to work. Therefore, it has been suggested in recent case studies that NPWT, as the primary treatment following wide excision of pilonidal sinus disease, could shorten the duration of wound healing and time to resume daily activities.8–12 However, no large case series or randomized studies on this subject have been reported in recent literature. The purpose of the current study was to evaluate NPWT after complete surgical excision of the pilonidal sinus. We conducted a randomized controlled trial to compare NPWT with standard open wound healing with regard to its efficacy and patients’ comfort.
MATERIALS AND METHODS Patients
All patients requiring surgical treatment for a pilonidal sinus at our hospital between October 2009 and May 2012 were evaluated for inclusion in the current trial. The indication for surgery was either a symptomatic pilonidal sinus with or without a previous abscess of the sinus. Exclusion criteria for participation were age younger than
16 years, a previous attempt at surgical excision of pilonidal disease, and the inability to undergo frequent follow-up. Moreover, patients in whom the pilonidal sinus was situated less than 3 cm from the anus were also not considered for inclusion, because the NPWT device could not be placed into position locally. Patients were requested to sign the informed consent form before random assignment, and were given an information prospect of the study. Randomization took place 1 day before the scheduled operation to facilitate the presence of a NPWT device in the operating room when required. The randomization process was conducted by the principal investigator of the study by using a computer-generated randomization list without any restrictions such as block size. Study Protocol
Before the start of the study, the local medical ethics committee had approved the study protocol. Patients were randomly assigned at the outpatient clinic to undergo NPWT (device was applied directly after surgical excision) for 14 days, or to undergo standard open wound care. It was evaluated whether it was feasible to apply NPWT in the pilonidal sinus region, ie, whether the position of the NPWT device would hinder its use in a correct way. The primary end point of the study was time to complete wound healing, defined as the number of days until full skin closure was achieved. Secondary end points were the wound size ratio at postoperative day 14 (wound size at postoperative day 14 (T1) divided by wound size at postoperative day 0 (T0), ie, wound healing rate after 14 days), the visual analog scale score at postoperative day 14, time to resume daily activities such as work or school (patient’s self-report), and recurrence of the pilonidal sinus within 6 months after closure of the wound. Surgery
The same surgical technique was applied in all patients. Surgical excision was performed under spinal anesthesia with the patient in the prone jackknife position (Fig. 1). The fistula was probed by using a blunt needle. Methylene blue was injected to define the exact borders of the cyst. An elliptical incision of the skin was made around the pilonidal sinus. Surgical diathermy was used for further complete excision of the cyst, if necessary, up to the level of the os coccygis (Fig. 2). After excision of the pilonidal sinus and removal of the tape used for patient positioning (Fig. 1), the length, width, and height of the wound (all in centimeters) were measured in the operating room and documented. When hemostasis was obtained, a porous silicone wound dressing was left in the wound in all patients. In the postoperative phase, all patients were advised to take paracetamol on a regular daily basis (1000 mg 4 times a day) and an additional nonsteroidal anti-inflammatory drug when needed.
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Biter et al: Is There a Place for Vacuum Therapy?
at the first application of the sponge to minimize postoperative pain caused by negative pressure on the periost of the os coccygis; it was removed at the first outpatient appointment. During follow-up, the sponge was replaced at postoperative days 3, 7, and 10 at the outpatient clinic. At day 14, NPWT was finished, and regular wound care was started: patients were advised to rinse the wound 3 times daily until a superficial wound was achieved; hereafter, the rinsing frequency was reduced. Standard Open Wound Healing
FIGURE 1. Patient with pilonidal sinus disease after positioning in the operating room (jackknife position).
Negative-Pressure Wound Therapy
If the patient was randomly assigned to NPWT, the vacuum-assisted closure device was placed directly by an experienced surgeon or wound care nurse in the operating room after surgical excision. First, a sponge was positioned in the wound on top of the surrounding skin. A topical skin adhesive (Dermabond) was applied to the borders to prevent skin damage. The NPWT device (consisting of an open-pore foam covered by an adhesive semipermeable dressing) was applied and connected to a special medical vacuum (Fig. 3). A negative pressure of 125 mm Hg was adjusted to the wound 24 hours a day. In the NPWT group, the porous silicone wound dressing was only placed
In the control group, the wound was left open after surgical excision. A silicone wound dressing was applied with an absorbent bandage on top. Patients were advised to rinse the wound 3 times daily during the first 2 weeks after excision. No special dressings were applied, unless the wound appeared sloughy and/or retention of pus was noted. Follow-up
Follow-up consisted of a predetermined schedule for all patients at the outpatient clinic. Inspection was done by a surgeon together with a wound care nurse. Each patient returned to the hospital at postoperative days 3, 7, 10, and 14 for wound inspection. Wound size, complications (such as infection [defined as pain and redness of the wound], abscess [defined as retention of pus in the wound], and bleeding), and pain score (measured by the visual analog scale score) were documented. After 2 weeks, all patients visited the outpatient clinic on a weekly basis for inspection and wound measurement until the wound was closed completely. Six months after wound closure, there was 1 final check for the recurrence of pilonidal sinus disease. Statistical Evaluation
Before the start of this study, no sample size calculation had been performed. The available literature on using NPWT in patients who have pilonidal sinus is scarce, making a valid calculation impossible. Data were prospectively
FIGURE 2. Wound after complete excision of the pilonidal sinus.
FIGURE 3. The NPWT device is applied on the wound after excision of the pilonidal sinus. NPWT = negative-pressure wound therapy.
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Diseases of the Colon & Rectum Volume 57: 12 (2014)
TABLE 1. Patient characteristics
Sex, male/female Age, ya Smoking (current smokers), n (%) Diabetes mellitus, n (%) Previous abscess, n (%)
TABLE 2. Results
NPWT (N = 24)
Control (N = 25)
18/6 23 (16–44) 6 (25)
23/2 29 (16–65) 6 (24)
1 (4) 10 (42)
1 (4) 12 (48)
NPWT = negative-pressure wound therapy. a Median value with its range presented within parentheses.
collected and stored in a database. Data analysis was performed in SPSS version 17.0 (SPSS, Chicago, IL). Statistical analysis appropriate for nonparametric data was used. Two-sided p values of
