Review question
Does the use of a graft during surgery to the parotid glands prevent Frey's syndrome?
Background
The clinical symptoms of Frey's syndrome include sweating and flushing of the cheek when eating and chewing. It results from abnormal regrowth of damaged autonomic nerve fibres of the parotid glands, for example during surgery for parotid gland tumours. It is unclear whether placing a graft between the skin flap and the parotid bed during surgery can prevent this syndrome. Various types of grafts can be used, including biomaterial or skin, muscle or other tissue from the patient. These grafts may possibly hinder the abnormal connections of the nerves controlling the sweat glands and parotid glands when the cut nerves are re-linking after surgery.
Study characteristics
We included three studies with 124 participants in this review, but the quality of these studies was not ideal. All of the participants in the studies had tumours of the parotid glands and were undergoing surgery to part of the glands. The studies assessed two types of grafts, tissue obtained from the sternocleidomastoid muscle and a biomaterial (a collagen framework without cells).
Key results
Two studies compared a tissue graft obtained from the sternocleidomastoid muscle to no graft. It is not known whether this type of tissue graft can prevent Frey's syndrome because the available evidence is very uncertain.
One study compared a biomaterial graft to no graft. This type of graft may result in little or no difference to the incidence rate of Frey's syndrome, but the evidence is very uncertain. It may make the patient's wound slightly more likely to become infected.
Certainty of the evidence
The evidence in this review is mostly of low or very low certainty, because of the small number of studies on this question and the risk of bias in these studies. The findings must therefore be treated with caution and further studies are needed to draw reliable conclusions.
The evidence in this review is up to date to 5 February 2019.
The evidence for the effectiveness of graft interposition in preventing Frey's syndrome is of low or very low certainty. The use of acellular dermal matrix may be associated with an increase in the wound infection rate, and little or no difference in the incidence of seromas or sialoceles. Further studies are needed to draw reliable conclusions.
Frey's syndrome is characterised by transient flushing and sometimes facial sweating in the area of the auriculotemporal nerve. It most commonly occurs after parotidectomy, but other causes may include submandibular gland surgery, mandibular condylar fracture, obstetric (forceps) trauma, sympathectomy and metabolic disease. Although the pathophysiology of Frey's syndrome remains controversial, the generally accepted hypothesis is that it occurs as the result of injury to the auriculotemporal nerve.
There is currently no clear evidence to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome, therefore the prevention of this symptom during surgery is important. The main method used for prevention is the interposition of a graft between the skin flap and the parotid bed during surgery. Biomaterials, allograft or autograft can be used for this purpose.
To evaluate the effects and safety of biomaterial, allograft or autograft interposition for the prevention of Frey's syndrome in patients undergoing parotidectomy, and to identify its effect on prevention and delayed occurrence.
The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Cochrane Register of Controlled Trials (CENTRAL; 2019, Issue 2); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 5 February 2019.
We included randomised controlled trials (RCTs) in patients with parotid disease (including tumours, inflammation, trauma etc.) undergoing parotidectomy with a minimal follow-up period of six months. We planned to include trials with interventions including biomaterial, allograft or autograft interposition alone or in combination with other surgical techniques. We included trials that compared any graft interposition and no graft interposition, or different graft interpositions.
We used the standard methodological procedures expected by Cochrane. Our primary outcome measures were incidence rate of Frey's syndrome assessed clinically (Minor's starch-iodine test) and other complications (postoperative infection, subjective painful or restricted cervical movement, scar spread, rejection of the graft, complications related to the donor site such as accessory nerve injury and haematoma). Our secondary outcome measures were incidence rate of Frey's syndrome assessed by participants (by questionnaire) and sweating area assessed by Minor's starch-iodine test. We used GRADE to assess the certainty of the evidence for each outcome.
We included three RCTs (124 participants), two of which we assessed as at high risk of bias and one at unclear risk of bias. All studies were hospital-based and recruited participants undergoing superficial parotidectomy. Most participants were diagnosed with benign lesions of the parotid gland. Participants were followed up for more than six months. The studies evaluated the two comparisons shown below:
Sternocleidomastoid muscle flap versus no flap
Two studies assessed this comparison. Both assessed the effects of the sternocleidomastoid muscle flap procedure on the incidence rate of Frey's syndrome assessed clinically but neither showed a significant difference between groups (risk ratio (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.23; 24 participants and RR 1.23, 95% CI 0.88 to 1.73; 36 participants; very low-certainty evidence). We did not pool the data due to the high heterogeneity (I² = 87%).
One study found that the sternocleidomastoid muscle flap may result in little or no difference in other complications including haematoma (RR 2.18, 95% CI 0.09 to 50.16; 36 participants; low-certainty evidence), subjective painful or restricted cervical movement (RR 0.54, 95% CI 0.14 to 2.05; 36 participants; low-certainty evidence) and scar spread in the cervical region (RR 0.71, 95% CI 0.05 to 10.54; 36 participants; low-certainty evidence). Both studies reported the incidence rate of Frey's syndrome assessed by participants, with one reporting no events in either group and the other finding no evidence of a difference (RR 0.63, 95% CI 0.32 to 1.26; 36 participants; low-certainty evidence).
Acellular dermal matrix versus no graft
Only one study assessed this comparison. Use of an acellular dermal matrix graft may result in little or no difference to the incidence rate of Frey's syndrome (assessed clinically) in comparison with the no graft group, but the evidence is very uncertain (RR 0.08, 95% CI 0.00 to 1.25; 30 participants; very low-certainty evidence).
Acellular dermal matrix may slightly increase the wound infection rate compared with control (RR 17.00, 95% CI 1.02 to 282.67; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence of seromas or sialoceles (RR 2.33, 95% CI 0.66 to 8.23; 64 participants; low-certainty evidence). Acellular dermal matrix may result in little or no difference to the incidence rate of Frey's syndrome (assessed by participants) in comparison with the no graft group (RR 0.33, 95% CI 0.04 to 3.04; 64 participants; low-certainty evidence).