Head and neck surgery, thoracic surgery, and abdominal surgery, among other surgeries, sometimes generate refractory skin fistulae that connect the gastrointestinal tract or mediastinum to the skin/cutaneous wound. Such fistulae are very difficult to manage, even when free tissue is transferred to correct them. As a result, they significantly prolong the duration of treatment for the patient.
If there is extensive necrosis of the transferred tissue or the fistula is huge, reconstruction may be considered.1–4 Regardless of the treatment that is employed, it can take several weeks or months before esophagocutaneous and pharyngocutaneous fistulae resolve. This largely reflects the neck to chest anatomy and patient characteristics: this region associates with complex 3-dimensional structures, surrounding hard tissues, swallowing pressure, saliva inflow, lymphorrhea, poor general condition, chemotherapy, and radiotherapy, all of which hamper the healing of wounds in this region.
In 2013, Yang et al.5 reported that complications associated with head and neck reconstruction can be managed successfully by applying a conventional negative pressure wound therapy (NPWT) system. Moreover, NPWT is effective for treating refractory skin or soft-tissue ulcers.6 , 7 Although it is suggested that NPWT is contraindicated for sites at which malignant tumors are present because it may encourage metastasis, there is actually no direct evidence for this.8
In this case series study, we show that our novel NPWT approach employing a Penrose drain significantly reduces the closure time for patients with prolonged small fistulae, the diameter of which was less than 1 cm.
PATIENTS AND METHODS
Informed consent to undergo fistula treatment with our novel approach was obtained from all patients. The study was conducted according to the principles of the Declaration of Helsinki and its revisions and approved by the Institutional Review Board of Nippon Medical School Hospital (approval number, 29-01-883).
The case series consisted of all consecutive patients from February 2014 to February 2017 who underwent resection and reconstruction for head and neck or esophageal cancer and who then developed a small fistula (the diameter of which was less than 1 cm) that was treated with either our NPWT method or a second flap transfer that did not resolve the fistula or led to fistula recurrence and was then treated with our NPWT method.
NPWT Method with a Penrose Drain
After reconstructive surgery with soft-tissue transfer is completed, the fistula site is closed off with an adhesive film. A hole is made in the film, and the 6 mm Penrose drain, which is a split soft drainage tube, is inserted into the fistula. The drainage tube is then wrapped by a split sponge foam that is placed on the film overlying the fistula. A hole is made in another piece of adhesive film, after which the Penrose drain is threaded through the hole, and the film is adhered to the sponge foam and the surrounding skin. A conventional NPWT device (V.A.C., KCI USA, Inc., San Antonio, Tex.) is then placed over the film such that it places negative pressure on the Penrose drain (Fig. 1). The Penrose drain must be replaced every 3 days. At each change, the Penrose drain should be inserted less deeply into the fistula. This treatment should be continued for 1–2 weeks.
In total, 203 patients underwent head and neck or esophageal reconstruction surgery during the study period. Of these, 11 patients with an esophagocutaneous or pharyngocutaneous fistula underwent our novel NPWT using a Penrose drain. The patients consisted of 10 males and 1 female, and their average age was 67.4 years. All patients underwent complete resection of esophageal cancer (n = 4), laryngeal cancer (n = 3), oral cancer (n = 2), or hypopharyngeal cancer (n = 2). All fistulae were less than 2 cm in diameter and from 1 to 15 cm in length. In 6 cases, our NPWT was used to resolve fistulae that arose after tumor resection and reconstruction. In the remaining 5 cases, the patients developed a fistula after resection and reconstruction and the surgeon decided to repair it with a second flap transfer. However, the second flap transfer either did not resolve the fistula or the fistula recurred. Consequently, our NPWT was applied. All patients who underwent a second flap transfer received a pectoral major muscle cutaneous flap. The same flap was also used in 2 of the 6 patients who developed a fistula after resection. The remaining 4 patients received an anterolateral thigh flap, a free jejunum flap, a fibula osteocutaneous flap, and a forearm flap, respectively (Table 1).
The total duration of NPWT per patient was between 7 and 28 days (average, 10.2 days). In 9 of the 11 patients (81.8%), NPWT was stopped after 1 week and the fistula healed completely with external treatments 2–4 days later (ie, 9–11 days after NPWT started). The fistulae of the remaining 2 patients were refractory and recurred after being apparently resolved by the NPWT. As a result, NPWT was repeated. It took 21 and 28 days of NPWT in total before these fistulae healed. Thus, healing was only observed 43 and 62 days after NPWT started. The only adverse event that was observed was contact dermatitis due to tape (3 cases) (Table 1).
All patients were able to ingest food after complete wound healing was achieved.
At the last follow-up more than 6 months after tumor resection, 9 patients were still alive, and there was no evidence of disease. The remaining 2 patients (patients 6 and 7) have died from the disease.
A 68-year-old man underwent resection of hypopharyngeal cancer after chemoradiotherapy. A free jejunal and delto-pectoral flap was transferred. Seven days after surgery, a fistula between the cervical area to under the delto-pectoral flap was detected (Fig. 2A). Standard treatments such as washing were performed for 7 days. Our NPWT method was then performed for 7 days (Fig. 2B, C). The fistula exhibited complete healing 3 days after NPWT finished. The patient was then able to restart oral ingestion. Six months after NPWT finished, fistula recurrence was not observed (Fig. 2D).
A 67-year-old man underwent resection of a lower gingiva carcinoma followed by reconstruction with a fibula osteocutaneous flap. After reconstruction, a fistula from inside the oral cavity to the skin developed (Fig. 3A). Standard conservative treatment, such as topical medication and washing, was implemented for 4 months but improvements were not observed. Thus, we applied our NPWT method for 7 days (Fig. 3B). Two days after NPWT was completed, the wound had healed completely (Fig. 3C). The fistula did not recur.
Free or pedicled soft-tissue transfer after head and neck or esophageal cancer resection is now a standard surgical procedure. Moreover, if a huge fistula occurs in this area, the surgeon may again consider using a free or pedicled soft-tissue flap to correct it. However, all these procedures can be complicated by the development of small fistulas that are often difficult to manage and, depending on the individual case, may require several months of conservative treatment to resolve.9 , 10
Our recent case series study suggests that free or pedicled soft-tissue transfer associates with a relatively low rate of fistula formation in cancer patients who require esophageal reconstruction.11 Similarly, a review and a case–control study showed that compared with primary closure, which associates with fistula formation rates of 20–50%, vascularized tissue transfer reduces fistula formation to 15–20%.12 , 13 However, if a fistula does develop and flap surgery is performed again to repair it, the risk of complications increases: these complications include infection, donor-site mobility, and flap necrosis, as well as formation of another fistula or relapse of the original fistula.14 Indeed, McLean et al.15 reported that reconstruction surgery for fistula formation associates with high rates (35.3%) of fistula relapse.
Poor nutritional status, the use of adjuvant chemoradiotherapy, and various anatomical aspects of this area of the body contribute to development of refractory fistulae. If there is some tissue necrosis and/or the digestive tube suture exhibits some dehiscence, saliva will leak into the surrounding wounds and out through the cutaneous wound. The pressure of swallowing will then expand the fistula and further exacerbate saliva leakage.
Saliva leakage and swallowing pressure also prevent the wound from closing. In addition, the tendency toward infection and the frequent swallowing pressure mean that using simple sutures to repair the digestive tube often fails. Thus, to ensure complete wound healing, it is necessary to prevent saliva leakage and induce wound adhesion that can withstand the swallowing pressure.
In 1997, Argenta and Morykwas6 , 7 introduced the concept of using NPWT to manage complicated wounds. Since NPWT greatly promotes wound healing, this breakthrough method is now widely used all over the world in many specialties, including plastic surgery, general surgery, and orthopedics.16–19 Recently, incisional NPWT was introduced as a new tool for promoting the healing of high-risk surgical-site wounds.20
Two small studies reported that NPWT had good outcomes when it was applied to 13 patients with complicated wounds (including wounds complicated by fistula) after resection of head and neck cancer followed by flap transfer.5 , 21 Thus, in head and neck or esophageal cancer surgery, regardless of whether free soft tissue transfer is or is not performed, the treatment options for patients who develop a fistula after tumor resection include conservative treatment (which may take 2 or 3 months to induce complete wound healing) or transfer of free or pedicled transplants of fresh, soft, and uninfected tissues (which, if successful, resolves the fistula immediately). If the new tissue transfer does not immediately resolve the fistula or the fistula recurs, NPWT can be applied (Fig. 4).
However, the normal NPWT method has some problems with respect to treating small fistula. First, it is difficult to speculate that high pressure accurately effects deep and small fistula. Second, when removing the NPWT system, care should be taken that the fragment of NPWT sponge-form does not remain within small fistula. Such a foreign body presents additional problems, such as infection or granulation.
We showed here that our new NPWT method with the Penrose drain effectively resolved the small fistulae that developed after head and neck or esophageal tumor resection followed by free tissue transfer. It also resolved the fistulae in the patients whose small postresection fistula was not resolved by or recurred after a second flap transfer. Moreover, in most cases, the NPWT drastically shortened the time spent waiting for the fistula to heal: in 9 of our 11 cases, the fistula healed completely 9–11 days after NPWT was started.
In this setting, it is likely that NPWT promotes and accelerates wound healing by increasing the granulation of the engrafted tissue and the discharge of saliva and accumulated fluid. The negative pressure probably also helps to force the mucosal tissues together (crimping) and reduces the dead space (Fig. 5).
It should be noted that, in our method, a split sponge was wrapped around the Penrose drain and then placed on top of a film overlying the fistula. In other words, the sponge was not placed directly into the fistula opening. Consequently, when the NPWT device was placed over the wound, only the inside of the wound was subjected to a constant negative pressure that was applied by the soft Penrose drainage tube. This setup eliminates the possibility that the NPWT aspirates important tissue components such as blood vessels.
The Penrose drain was first introduced in 1890. We chose it for our NPWT system because it effectively applies negative pressure. This ability is caused by its fine grooves, which prevent the tube from collapsing completely under negative pressure.22
We chose to use the V.A.C. (KCI USA, Inc., San Antonio, Tex.) NPWT system to generate the negative pressure because it applies the same pressure continuously and associates with good control over the intensity of pressure. We did not use a conventional silicon Blake drain with a portable suction reservoir because, even if this setup could be adapted to our purposes, it is hard to get this device to continuously apply the same negative pressure. There was also concern that the medical staff may apply the wrong negative pressure release time by mistake.
In 2 of 11 patients, complete healing was only achieved after applying our NPWT method twice. This may have been due to difficulties in applying the tape due to anatomical and structural reasons, the onset of cervical skin erosion due to the saliva from the fistula, and the inhibition of adhesion on the mucosal side due to excessive insertion of the Penrose drain. Thus, our NPWT method may not be suitable for patients in whom the fistula is close to a tracheostomy or when the skin around the fistula exhibits erosion due to saliva leakage or radiotherapy.
Our NPWT system with a Penrose drain effectively shortened the time spent waiting for fistulae to heal after head and neck or esophageal cancer surgery. The usefulness of this method for other diseases warrants further investigation.
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