Abstract
Fistula formation in head and neck wounds is considered one of the most challenging complications that a head and neck reconstructive surgeon may encounter. The current mainstay of treatment is aggressive surgical debridement followed by vascularised soft tissue coverage. Negative pressure wound therapy (NPWT) has been successfully used for the closure of complicated wounds for decades. This study analysed the outcomes and complications of NPWT in the management of head and neck wounds with fistulas. A systematic search of studies published between January 1966 and September 2019 was conducted using the PubMed, MEDLINE, EMBASE, and SCOPUS databases and using the following key words: “negative pressure wound therapy,” “head and neck,” and “fistula.” We included human studies with abstract and full text available. Analysed endpoints were rate of fistula closure, follow‐up duration, and complications if present. Nine retrospective case series (Level IV evidence) that collectively included 122 head and neck wounds with orocutaneous fistulas, pharyngocutaneous fistulas, and salivary contamination were examined. The number of patients included in each study ranged from 5 to 64. The mode of NPWT varied among the included studies, with most adopting a continuous pressure of −125 mm Hg. Mean durations of NPWT ranged from 3.7 to 23 days, and the reported fistula closure rate ranged from 78% to 100%. To achieve complete wound healing, six studies used additional procedures after stopping NPWT, including conventional wound dressings and vascularised tissue transfer. Information regarding follow up was provided in only three of the nine studies, where patients were followed for 5, 10, and 18 months. No serious adverse events were reported. NPWT for head and neck wounds with fistulas may be considered a safe treatment method that yields beneficial outcomes with a low risk of complications. The current data originated mainly from studies with low levels of evidence characterised by heterogeneity. Therefore, definitive recommendations based on these data cannot be offered. Additional high‐quality trials are warranted to corroborate the findings of this systematic review.
Keywords: fistula, head and neck reconstruction, negative pressure wound therapy
1. INTRODUCTION
Fistula formation in head and neck wounds is considered one of the most challenging complications in head and neck reconstruction (Figure 1A, B). Poor nutritional status, multiple comorbidities, extensive resection for head and neck malignancies, and postoperative irradiation are risk factors that may cause orocutaneous fistulas, pharyngocutaneous fistulas, or salivary contamination of head and neck wounds.1 These complications may delay oral intake, necessitate prolonged hospitalisation, incur additional health care costs, or cause salivary contamination of neck contents that may lead to life‐threatening infections or even vascular rupture.2
Figure 1.
A, The patient with prior oral cancer resection, neck dissection, and postoperative irradiation developed orocutaneous fistula (arrow) after resection of recurred oral cancer and free flap reconstruction. B, The application of negative pressure wound therapy for the fistula
Contemporary management methods include nutritional support through a nasogastric tube that bypasses the head and neck region, hyperbaric oxygen, and aggressive wound care.3 However, many head and neck wounds remain refractory to these methods and result in persistent chronic pain that can extend hospital stays and increase health care costs. Surgical fistula closure is reserved for cases where conservative measures have failed; such closure is often accomplished through extensive wound exploration, aggressive debridement, or subsequent vascularised tissue transfer.4
In 1993, Fleischmann et al first described the method of applying negative pressure to treat open or infected wounds.5 In 1997, based on Fleischmann's work, Argenta and Morykwas et al introduced the negative pressure wound therapy (NPWT) system for management of complicated wounds.6, 7
Negative pressure applied by the NPWT system improves the perfusion of dermal and subdermal tissues. In addition, this negative pressure reduces the bacterial load and wound oedema and facilitates growth of granulation tissue while maintaining a relatively clean and isolated system.8, 9 Since then, the NPWT system has been used in not only plastic surgery but also trauma surgery, orthopaedic surgery, and even obstetrics.10, 11, 12, 13 NPWT treatment has been shown to result in shorter healing times for wounds with fewer dressing changes, improved outcomes, and reduced hospital costs.14 However, despite the benefits of NPWT, its role in treating head and neck wounds with fistulas has not been studied extensively. The present systematic review analysed the outcomes and complications of using NPWT in the management of head and neck wounds with fistulas.
2. MATERIALS AND METHODS
To achieve a high standard of reporting, we followed procedures specified in the 2009 update of the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines (http://www.prisma-statement.org/). Our compliance with the PRISMA guidelines is explained in the Appendix. The protocol of the present systematic review is available through PROSPERO (http://www.crd.york.ac.uk/PROSPERO/), where it has been assigned the following registration number: CRD42018106143.
2.1. Literature search
Two authors independently performed literature searches to identify studies that had investigated the use of NPWT in head and neck wounds with fistulas. We searched the MEDLINE database for studies published between January 1966 and September 2019 by using the following key words: “Head and Neck Neoplasms” (MeSH term), “Negative Pressure Wound Therapy” (MeSH term), and “fistula.” In addition, free text words, namely, “head and neck,” “vacuum‐assisted closure,” and “negative pressure dressings,” were used instead of MeSH terms to prevent recent articles that had not yet been assigned a MeSH label from being missed. The EMBASE database was searched using the following terms: “head and neck,” “negative pressure,” and “fistula.” The SCOPUS database was also checked for relevant studies using the keywords, “head and neck,” “negative pressure,” and “fistula.” Although the search was not restricted to any language, only studies published in English were considered in the systematic review.
2.2. Selection criteria
Our inclusion criteria were as follows: studies dealing with application of NPWT for head and neck wounds with fistulas, studies published in English, studies analysing humans, and studies for which full texts were available. The following exclusion criteria were used for study selection: congenital fistula in adults or paediatric population, conference abstracts, and non‐English articles.
Two authors independently extracted data in two steps: (a) titles and abstracts and (b) full‐text articles. Full articles were examined by both authors when titles and abstracts did not provide enough information for a definite decision. When the two authors did not agree, the third author was included, and consensus was reached after discussion.
2.3. Participants
Adult patients with head and neck wounds with fistulas managed using NPWT were included.
2.4. Outcome measures
The primary outcome measures were wound healing status and duration of NPWT. The secondary outcome measure was complications because of NPWT.
2.5. Data extraction
The following data were extracted from each article for analysis: journal, year of publication, author, study design, number of patients with head and neck wounds, patient diagnoses, prior surgeries, types of wounds, modes of NPWT, duration of NPWT, wound healing status, additional procedures performed after NPWT, follow‐up duration, and complications because of NPWT.
2.6. Methodological quality assessment
Two authors independently assessed the methodological quality of the included articles. To assess the methodological quality of non‐randomized controlled trials, we used the methodological index for non‐randomised study guidelines,15 which consist of the following 12 items: (a) a clearly stated aim, (b) inclusion of consecutive patients, (c) prospective collection of data, (d) endpoints appropriate to the aim of the study, (e) unbiased assessment of study endpoints, (f) follow‐up duration appropriate to the aim of the study, (g) less than 5% lost to follow up, (h) prospective calculation of the study size, (i) adequate control group, (j) contemporary groups (control and study groups should be managed during the same period, with no historical comparison), (k) baseline equivalence of groups, and (l) adequate statistical analyses. Each item has a maximum score of 2, and the maximum total score for all 12 items is 24; scores of ≥16 and <16 indicate high and low methodological quality, respectively.
3. RESULTS
The flowchart of this systematic review is shown in Figure 2. In the literature search, we initially identified 226 publications, 44 of which were retrieved for further information. After examination of the 44 retrieved articles and filtration based on our inclusion criteria, 9 articles were selected for the final analysis (Table 1). All authors completely agreed on the inclusion of these nine studies. The included studies consisted of nine retrospective case series (Level IV evidence) of low methodology quality. In these nine studies, the number of patients in each ranged from 5 to 64, including a total of 122 patients who received NPWT for management of fistulas in head and neck wounds.
Figure 2.
Preferred reporting items for systematic reviews and meta‐analyses flow diagram describing selection process for included studies. HN, head & neck; NPWT, negative pressure wound therapy
Table 1.
Summary of patient characteristics of the included studies
| Author | Study design (LOE) | Methodology quality (Score) | Mean age (range) | Head and neck fistula | Mode of NPWT |
|---|---|---|---|---|---|
| Rosenthal16 | Retrospective (IV) | Low (MINORS score: 7) | 59 | Pharyngocutaneous fistula (n = 4) | −75 to −125 mm Hg (cont.) |
| Dhir17 | Retrospective (IV) | Low (MINORS score: 9) | 63.2 (48‐75) | Salivary leakage (n = 7) | −110 mm Hg (cont.) |
| Reiter18 | Retrospective (IV) | Low (MINORS score: 4) | 57.8 (39‐80) | Salivary fistula (n = 5) | −125 to −150 mm Hg (cont.) |
| Yang19 | Retrospective (IV) | Low (MINORS score: 5) | 50 (35‐62) | Saliva leakage and fistula (n = 8) | −125 mm Hg (cont.) for 24 hours, then switch to 5:1 on‐off mode |
| Asher20 | Retrospective (IV) | Low (MINORS score: 6) | 63 ± 8 | Pharyngocutaneous fistula (n = 7) | −125 mm Hg (cont.) intra‐pharyngeal use, combined regional or free tissue transfer |
| Asher21 | Retrospective (IV) | Low (MINORS score: 6) | 60 ± 14 | Salivary contamination (n = 64) | −125 mm Hg (cont.) |
| Tian22 | Retrospective (IV) | Low (MINORS score: 5) | 67 (33‐80) | Orocutaneous fistula (n = 11) | −50 to −125 mm Hg (cont.), combined Hydrogum dental paste sealant |
| Loaec23 | Retrospective (IV) | Low (MINORS score: 7) | 65 y 9 mo | Pharyngocutaneous fistula (n = 7) | −100 to −125 mm Hg (cont.) |
| Zhang24 | Retrospective (IV) | Low (MINORS score: 7) | 62 (47‐73) | Submandibular fistula (n = 9) | −125 mm Hg (cont.) |
Abbreviations: LOE, level of evidence; MINORS, Methodological Index for Non‐Randomised Studies; NPWT, negative pressure wound therapy.
Mode of NPWT varied among the included studies, with most applying a continuous pressure of −125 mm Hg. The mean duration of NPWT ranged from 3.7 to 23 days. To achieve complete wound healing, six studies used additional procedures after stopping NPWT, including conventional wound dressings and vascularised tissue transfer. Follow up was only mentioned in three of the nine studies; patients were followed for 5, 10, and 18 months. The reported successful fistula closure rate ranged from 78% to 100%. No serious adverse events were reported (Table 2).
Table 2.
Summary of patient outcome of the included studies
| Author | Duration of NPWT (range) | Mean follow up (range) | Fistula closure rate (%) | Additional procedures | Complications |
|---|---|---|---|---|---|
| Rosenthal16 | Mean: 6.25 d | Minimum 5 mo | 92 | 1 with RFF cover | No complications |
| Dhir17 | Mean: 11.4 d (5‐28) | Not stated | 84 | Dermal graft, salivary diversion, regional flap cover | Not stated |
| Reiter18 | Mean: 10.3 d (6‐18) | Not stated | 78 | Regional flap cover | Not stated |
| Yang19 | Mean: 10.8 d (4‐24) | Not stated | 85 | 1 with skin graft, 1 with free flap cover | Not stated |
| Asher20 | Mean: 5.8 ± 1.7 d | Not stated | 92 | Not stated | Sponge soiled with stomach content after vomiting |
| Asher21 | Mean: 3.7 ± 1.4 d | Not stated | 100 | Flap transfer | Retained sponge, bleeding from pedicle, air leaks |
| Tian22 | Median: 19 d (6‐36) | Not stated | 90 | Not stated | Not stated |
| Loaec23 | Mean: 23 d (11‐42) | 10 mo (6‐24) | 100 | Alginate packing, conventional mesh dressings | Air leaks |
| Zhang24 | Mean: 9.6 d (7‐12) | 18 mo (4‐27) | 100 | No | No complications |
Abbreviations: NPWT, negative pressure wound therapy; RFF, radial forearm flap.
3.1. Description of included studies
Rosenthal et al16 applied NPWT to four patients with pharyngocutaneous fistulas, with a minimum follow‐up duration of 5 months. Three patients had previously received irradiation. The researchers applied a continuous pressure of −125 mm Hg for the fistula to remain sealed. The average treatment duration was 6.25 days with a 92.5% achievement of granulation tissue on the wound immediately after NPWT completion. One patient required a free radial forearm flap for mucosal and external coverage.
Dhir et al17 recruited 19 head and neck cancer patients with 33 wounds. Of these patients, seven (37%) had salivary leaks, and 21% had vascular or bone exposure. The researchers applied a continuous pressure of −100 mm Hg to wounds. The mean duration of NPWT was 11.4 (range, 5‐28) days in hospital. The wounds of 84% of the patients healed completely without requiring further surgical treatment. Furthermore, 12% of the patients and 21% of the wounds required dermal grafting for vessel exposure; 9% of the patients and 16% of the wounds required salivary diversion; and 9% of the patients and 16% of the wounds required regional flap reconstructions, including one superior trapezius flap and two deltopectoral island flaps. No complications were reported.
Reiter et al18 analysed 22 patients with head and neck wounds; 13 (56.6%) had flap loss or dehiscence, 6 (26.1%) had necrotising fasciitis with large skin defects, and 5 had salivary fistulas. The researchers applied continuous negative pressure between −124 and −150 mm Hg. Two patients required a continuous pressure of −75 mm Hg because of pain. The mean duration of NPWT was 10.3 (range, 6‐18) days. Furthermore, 18 patients (78%) achieved defect closure without further surgical treatment. Five patients required regional flap reconstructions for close remaining defects. No complications were reported.
Yang et al19 applied NPWT to 13 patients with complicated head and neck wounds after flap reconstruction. Of these patients, eight had saliva leakage with fistulas. The researchers applied a continuous pressure of −125 mm Hg for the initial 24 hours. Subsequently, they switched to a 5:1 on‐off treatment mode. Watertight suturing on the mucosal side was required to ensure air sealing and facilitate wound healing during use of the NPWT system. The mean duration of NPWT was 10.8 (range, 4‐24) days. Furthermore, 11 patients (85%) achieved wound healing with secondary intention. One patient required skin grafting, and one required free flap transfer. No complications were reported.
Asher et al20 analysed 12 patients who underwent laryngopharyngectomy and subsequent pharyngeal reconstruction. Seven patients developed pharyngocutaneous fistulas. Five patients prophylactically used NPWT because of the high risk of fistula formation. Intra‐pharyngeal negative pressure dressings (continuous pressure of −125 mm Hg) were used alongside regional or free tissue transfer. The mean duration of NPWT was 5.8 ± 1.7 days. Eleven (92%) patients achieved pharyngeal closure. Of the seven patients who developed fistulas, six achieved pharyngeal closure. Five patients who received prophylaxis started oral diets 3 weeks postoperatively. No serious adverse events were noted. One patient had difficulty maintaining an adequate seal and underwent early removal of NPWT. One patient had a sponge soiled with stomach contents after an episode of vomiting and underwent early removal.
Asher et al21 analysed 115 patients with head and neck wounds. Of these patients, 64 had salivary contamination. The mean wound size was 5.6 ± 5.0 cm. The researchers applied a continuous pressure of −125 mm Hg. The mean duration of NPWT was 3.7 ± 1.4 days. All patients' wounds (100%) healed completely. Of the 64 patients with salivary contamination, 20 (31%) underwent vascularised tissue transfer, 1 had an inadvertently retained sponge, 1 had a mucous plug in the endotracheal tube that was lodged in the NPWT device, 2 had bleeding from a flap pedicle, and 3 had air leakage.
Tian et al22 analysed 10 patients with 11 orocutaneous fistulas. Six patients had fistulas over the mouth floor, four had fistulas over the buccal/retromolar area, and one had a fistula between flaps. The median size of oral defects was 3.25 (range, 1.5‐4.5) cm. Before application of NPWT, Hydrogum dental paste sealant was applied over the mucosal side of the fistula. The researchers applied continuous pressure between −50 and −125 mm Hg. The median duration of NPWT was 19 (range, 6‐36) days. Nine patients (90%) achieved complete fistula closure, and no complications were reported.
Loaec et al23 applied continuous pressure of −100 to −125 mm Hg to seven patients with pharyngocutaneous fistulas. The mean duration of NPWT was 23 (range, 11‐42) days. All patients (100%) achieved complete wound healing. One patient had an early recurrent low‐output fistula at 1 week that was spontaneously resolved after 5 days without NPWT. The researchers used alginate packing after completion of NPWT for four patients. One patient required conventional mesh dressings after completion of NPWT. The researchers reported that air leaks had resolved after use of tulle gras dressing.
Zhang et al24 applied a continuous pressure of −125 mm Hg to nine patients with submandibular fistulas after reconstruction for osteoradionecrosis with a well‐healed oral mucosal side. The defect size ranged from 1.7 × 2.5 cm to 2.0 × 3.5 cm. The mean duration of NPWT was 9.6 (range, 7‐12) days. Successful secondary intention healing was noted in all patients within 2 weeks. After a mean follow‐up duration of 18 (range, 4‐27) months, no recurrence or infection was observed.
4. DISCUSSION
NPWT is a well‐established therapeutic approach used to facilitate rapid wound healing in various complex wound types. NPWT has been integrated into the new reconstructive ladder25 and has been used for the successful management of patients with trauma or even severe infection in the head and neck region.26, 27 However, information on the use of NPWT for head and neck wounds with fistulas remains limited.
In the studies included in the present systematic review, the fistula closure rate ranged from 78% to 100%. However, a standardised guideline regarding application of NPWT for head and neck wounds with fistulas is not available. Mode of NPWT varied among the included studies, with most applying a continuous pressure of −125 mm Hg. Rosenthal et al16 continuously applied negative pressure between −75 and −125 mm Hg to their patients; the researchers reported that the patients with head and neck fistulas required higher levels of negative pressure (−125 mm Hg) to retain the seal. Reiter et al18 continuously applied high negative pressures between −125 and −150 mm Hg. However, two of their patients could not tolerate the therapy and were put under lower pressure (−75 mm Hg). Yang et al19 set their continuous negative pressure to −125 mm Hg for the initial23 hours. From the second day, the researchers switched to intermittent suction of 5‐minute cycles with 1‐minute rests between cycles to prevent excessive maceration of normal skin.
In clinical practice, the sponge of the NPWT system is usually changed every 72 hours. According to data from the studies examined in this review, the mean duration of NPWT ranged from 3.7 to 23 days. NPWT resulted in complete closure of fistulas in all patients over a mean treatment duration of 23 (range, 11‐42) days. We believe that the duration of NPWT varied because of the following factors: patient characteristics (prior surgeries, irradiation, location of fistula, and pain tolerance), clinicians' clinical judgement, and cost of NPWT.
Several devices can be used to achieve an airtight environment in clinical practice. Tian et al22 indicated that, once a fistula with significant openings at either end has been identified, Hydrogum can be used to prepare a temporary seal at one end. After soaking in Hydrogum, a piece of gauze can be shaped to patch the end of a fistula. Use of Hydrogum enables a wound care team to create a sealant that fits the shape of the wound in question. Loaec et al23 used tulle gras dressing aspirated into leaking zones in their patients to ensure airtight dressing on application of NPWT. Reiter et al18 placed polyurethane foams directly into fistulas, and additional foams were used to cover wounds. Yang et al19 reported that, to improve the sealing of orocutaneous fistulas, watertight suturing on the mucosal side is required before application of NPWT.
For patients with pharyngocutaneous fistulas, intraluminal NPWT is an alternative treatment method. Asher et al20 used intraluminal NPWT to treat seven patients with pharyngocutaneous fistulas and five other patients requiring prophylactic treatment owing to perceived high risk of fistula formation. The researchers combined a continuous negative pressure of 125 mm Hg with regional or free tissue transfer. Six of the seven patients with fistulas achieved fistula closure, and the five prophylactic patients started oral diets 3 weeks postoperatively.
To achieve complete wound healing, six studies used additional procedures after stopping NPWT, including conventional wound dressing and vascularised tissue transfer. Reiter et al18 reported that 6 of 11 patients who had been irradiated prior to NPWT were managed without further surgical reconstruction of the remaining defect. Although improved wound healing was reported frequently in these patients, NPWT alone was insufficient.
Concerns exist regarding the use of NPWT in the head and neck region, including possible high output of saliva of more than 1000 mL per day, presence of thin skin in the region, exacerbation of condition after irradiation, and accidental injuries to great vessels in the neck region during prolonged application of continuous negative pressure.
An enterocutaneous fistula (ECF) is considered one of the most challenging complications that a general surgeon may encounter. A systematic review of 10 case series that collectively enrolled 151 patients reported that the median rate of ECF closure because of NPWT was 64.6% (range, 7.7‐100%), with complete healing achieved within 58 (range, 12‐90) days. No complications were reported in any, but one, of these studies; in the one exception, abdominal wall disruption and intestinal obstruction were identified in a few patients. The researchers suggested that NPWT is a safe method for treating ECF.28
One of the disadvantages of NPWT is that patients may experience varying degrees of pain, especially during dressing changes. Loaec et al23 suggested injecting 0.2% lidocaine directly into the foam before removal. In addition, applied negative pressure should be lowered if a patient experiences pain during application of negative pressure to the foam.
The cost of the NPWT system differs depending on the institution, but generally, it ranges from USD100 to USD200 per day for inpatient care. Given the short period for which this system is typically used, the cost appears to be justified. The cost of the NPWT system is relatively low compared with that of long‐term hospitalisation for local wound care management or an additional surgical procedure. Most notably, application of NPWT usually reduces the workload of nursing staff.29, 30
This systematic review had some limitations. All analysed studies had a retrospective case series design with a small number of patients, lacked data to illustrate cost‐effectiveness, and lacked a control group. Only three studies provided information regarding follow‐up duration. These drawbacks could limit the application of NPWT in clinical practice for treating patients at high risk of fistula formation.
5. SUMMARY
NPWT may be a promising method of treating fistulas developed in wounds in the head and neck regions, with improved closure and low risk of complications. However, low methodological quality of the studies included in this review limited our recommendations for NPWT because of practice standards. Additional high‐quality trials are warranted to corroborate the findings of this systematic review.
AUTHOR CONTRIBUTIONS
F.‐Y.L., P.‐Y.H., and P.‐Y.H. contributed to the concept design, drafting, revision, and approval of final manuscript to be submitted.
Lin F‐Y, Huang P‐Y, Cheng H‐T. Systematic review of negative pressure wound therapy for head and neck wounds with fistulas: Outcomes and complications. Int Wound J. 2020;17:251–258. 10.1111/iwj.13264
Fu‐Yu Lin and Pin‐Yi Huang contributed equally to this work.
Podium presented at the 27th conference of European Wound Management Association. 3‐5 May 2017, Amsterdam, the Netherlands.
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