Blepharoplasty

Blepharoplasty Study (Richard M. Bentall)

A pilot study, conducted by Dr. Bentall with 21 patients, established clinically meaningful success criteria, such as the effects of pulsed RF energy on postoperative edema and bruising. The enlarged second study, with 61 patients, aimed at obtaining numerical estimates of edema and bruising thus confirming the results of the earlier study as well as quantifying edema and bruising. During the eighties quantifying edema and bruising was mostly subjective and the use of more than one assessor to evaluate and measure the affected area was used. 

The surgical procedure of blepharoplasty may be performed under general or local anaesthesia and involves removal of excess skin and fat from tl)e upper and/or lower eyelids. The low tension in the skin of the peri-orbital region means that post-Operative oedema and bruising are inevitable. It is an ideal clinical model for double-blind evaluation of pulsed RF treatment because it provides asymptomatic patients who each undergo a bilateral procedure performed by a single surgeon; the patient acts as his, or her own control. A double-blind pilot study and a recently completed study are described.

Pilot Study: (Nicolle and Bentall, 1982)

Aim

The purpose of this study was to determine the effects of pulsed RF energy on the post­operative course of oedema and bruising following blepharoplasty surgery.

Method

The pilot study involved 21 patients who had surgery performed under local or general anaesthesia. Active and placebo antennae were manipulated to form a spectacle shape that was held in place on top of wound dressings. The spectacles were applied immediately post­operatively and removed after 24 hours. Photographic colour transparencies were taken of the patient on the first day (when the dressings were removed), and on the third day (when the sutures were removed), and at six days at the follow-up visit. Assessment of these slides was made by an independent clinician.

Device Specifications

 

  • Power Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5 Volt battery
  • Carrier Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 MHz
  • Pulse Width . . . . . . . . . . . . . . . . . . . . . . . . . ….. . . . . . . .: 100 microsecs
  • Pulse Repetition Frequency . . . . . . . . . . . . . . . . . . . . . . 1 KHz

 

Results

The independent clinician assessed the slides and determined which of the peri-orbital regions showed clinical evidence of an improvement – a reduction in oedema, bruising and scleral haemorrhage. Two patients were excluded due to technical difficulties with the devices. Of the remaining 19 patients, 11 had visible reduction of the post-operative signs on the actively treated side, this improvement was still discernable at the sixth day follow-up visit. In six patients, oedema and bruising was so slight that no difference was visible. Two patients appeared to have a reduction in the severity of signs on the placebo treated side.

Blepharoplasty Study (Bentall, Bentall and Nicolle 1984-85)

Aim

In the pilot study no attempt was made to obtain any numerical estimates of oedema and bruising on which to perform an analysis. The purpose of the present study is to attempt to replicate the clinical effect observed in the pilot study and to quantify that effect using a larger sample of patients.

Method

The subjects of this clinical study were the patients of a plastic surgeon (Mr F V Nicolle) practising in London, England. All patients attending for bilateral blepharoplasty who gave their informed consent to participation were entered into the study; there were no specific exclusion criteria. Patients receiving surgery to the upper lids and/or the lower lids were included.

Patients were randomly assigned a pair of lensless spectacles to provide treatment to the lids of one eye but not the other. Active and placebo antennae were fitted into the light­weight spectacle frames and electrical components were housed in one leg of the frames. The placebo antenna was electrically shielded to prevent re-radiation from the active antenna which emitted pulsed RF. energy of the following specifications:

 

  • Nominal Power Output. . . . . . . .. . . . . . . . . . . . . . . . . . . 73 microW
  • Carrier Frequency. . . . . . . .. . . . . . . . . . . . . . . . . . . . . … …. 26 MHz
  • Pulse Width. . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . … 73 microsecs
  • Pulse Repetition Frequency . . . . . . . . . . . . . . . . . . . . ……… 900 Hz

 

Patients therefore acted as their own control and they were not aware which eye received treatment. Treatment commenced immecijate1y following surgery and the patients were instructed to wear the spectacles for 16 hours per day for the following three days. Apart from this no modifications were made to the normal post-operative care of the patients. Patients were asked to keep a log, on a small card provided, of the hours for which they wore the spectacles.

At each post-operative visit, that is at one day (a few cases only) and at three, four or five days after surgery, the nurse took a clinical photograph which was developed into a colour slide. The clinical logistics of the study precluded the taking of absolutely standard photographs. Therefore, in order to be able to make a correction to the measurements for the absolute size of each photograph, it was decided to place a centimetre scale reference sticker on the forehead of each patient prior to the clinical photograph being taken. Unfortunately this decision was not taken until after the first twelve patients had been entered into the study.

Measurements

The slides were used to obtain measurements of bruising and the amount each eye was open and they were also clinically assessed by a panel of three judges (one surgeon, one nurse and one lay person).

The bruising beneath each eye was recorded by projecting the slide onto a piece of acetate film and then drawing a planimetric trace of the bruised regions below the median palpebral fissure on each side. Only the areas of clearly defined red or purple bruising were included, not the rather diffuse areas of yellow. A System III Image Analysis Machine (AMS Limited) was then used to measure the area (in square centimetres) of the planimetric trace beneath each eye.

The slides were then projected onto a white piece of paper on which two thin black “+” signs had been drawn. The height of the palpebral fissure of each eye (at the point of bisection of the pupil – see Figure 1) and the size of the centimetre scale reference sticker (when present) were marked off on the “+” to signs with a thin pencil. The paper was then laid flat to enable the amount each eye was open and the length of the scale reference sticker to be. measured with a ruler.

To obtain ratings of the extent of oedema, bruising and scleral haemorrhage the three assessors examined the projected slides and recorded a rating of each clinical sign on a specially prepared form. The eyes were rated on the following scale for each sign:

 

  • 2R – The patient’s RIGHT eye shows “significantly less” _________ than the patient’s LEFT eye.
  • lR – The patient’s RIGHT eye shows less ________ than the patient’s LEFT eye but this is of “little clinical significance.”
  • 0 – There is no discernable difference between the patient’s LEFT and RIGHT eyes with respect to __________.
  • lL – The patient’s LEFT eye shows……etc cf lR above
  • 2L – The patient’s LEFT eye shows……etc cf 2R above

 

All of the Day 3 (4 or 5) photographs were assessed before any of the Day 1 photographs and the three assessors were blind as to the side of treatment of each patient.

Analysis

Bruising and eye-opening data were ana1ysed using related samples t-Tests and contingency tables were drawn up of the clinical assessment data and submitted to Chisquare tests of association.

Patients who failed to return the log of the times the spectacles had been worn or who wore the spectacles for fewer than eight hours per day for at least two days were excluded from the analysis.

Because not all of the pictures were taken with the patients wearing a scale reference sticker it was not possible to provide a correction factor to the measurement data in every case. Two analyses were therefore performed. To include all patients, the data was transformed to the percentage of total bruising or eye opening (see Figure 1) which was on the active side. The second analysis, which used the measured size of the scale reference sticker to convert the bruising data to actual areas, is considered to give a more meaningful picture even though it included fewer patients.

Results

PATIENT ENTRY

There were a total of sixty patients available for analysis in the present study. Two of these patients failed to return the log of the times when the spectacles were worn, two had worn the spectacles for fewer than the required 2 days and fourteen had worn the spectacles for fewer than the required 8 hours per day. There were thus forty-two patients entered into the analyses, of whom nine patients had slides from Day One Post-operation and of these two had slides from Day One only.

BRUISING

Figure 2 shows the area of bruising on the actively treated side as a percentage of the total bruising of both sides. It can be seen that for the patients as a whole the percentage of the total bruising which was on the active side was significantly less than 500/0, which is the outcome which would be expected to occur by chance (t = 2.56, p = 0.015). This is equivalent to a mean reduction in bruising on the active side of 20.7% (95 % confidence interval 5.2 % to 33.8%).

For the 28 patients who had worn the scale reference sticker it was possible to convert the bruised area measurements to actual areas. Figure 3 shows these results. It can be seen that the mean area of bruising on the placebo side was 2.88 sq cms and ‘for the active side it was 2.38 sq cms. This difference was again statistically significant (t = 2.47, P = 0.02) and indicates that there was 17.4 % less bruising on the actively treated than the placebo side (95 % confidence interval 3.7% to 31 %).

EYE OPENING

Figures 4 and 5 show, for the Day 1 and Day 3, 4 or 5 photographs respectively, the height of the palpebral fissure of the actively treated side as a percentage of the combined heights of the palpebral fissures of both sides. In neither case is this value significantly different from 50% (Day 1: t -0.52, NS; Day 3, 4 or 5: t =0.62, NS).

CLINICAL ASSESSMENTS

Although the clinical sign of oedema is more striking on the first day following surgery too few patients with Day 1 photographs were available to permit a meaningful analysis of the clinica1 assessments of them. Even for the Day 3, 4 or 5 photographs there were not sufficient patients to perform a reliable analysis of the full five assessment levels. However, by combining the two levels of assessment on each side (2R and 1R, and, 2L and 1L) and excluding the small number of cases assessed as showing no difference (see Table I), the cell entries are large enough to permit meaningful conclusions. It can be seen that there is a strong association between the clinica1 assessments made and the side of activity of the spectacles that the patient being assessed was wearing (Pearson Chisquare = 6.4, p = 0.0l).

TABLE 1. Clinical Assessment of Oedema by Surgeon Assessor

(Table combining assessment levels).

Less Oedema on Left Less Oedema on Right Total
LEFT SIDE ACTIVE 12 5 17
RIGHT SIDE ACTIVE 5 13 18
TOTAL 17 18 35


Table 2 similarly shows the same surgeon’s assessments of the patients’ bruising. Again the association between assessments made and side of activity of the spectacles worn is statistically significant (Pearson Chisquare = 5.9, p = 0.015).

Only six patients show any scleral haemorrhage and there is no evidence of its presence being associated with the side of activity of the spectacles being worn (Pearson Chisquare = 1.3, NS).

TABLE 2. Clinical Assessment of Bruising by Surgeon Assessor

(Table combining assessment levels).

Less Bruising on Left Less Bruising on Right Total
LEFT SIDE ACTIVE 12 4 16
RIGHT SIDE ACTIVE 6 12 18
TOTAL 18 16 34


The results of the other two assessors were in broad agreement with the findings of the surgeon though, with more assessments being recorded as “no discernable difference,” the same levels of significance were not attained.

Discussion

The results of the present study provide objective evidence for and statistical underpinning of the clinical impressions reported in the pilot study. After approximately three days of post­operative treatment with low-levels of pulsed RF energy there is a clear reduction in the area of bruising and in the observable signs of oedema around the treated eye in comparison with the untreated eye.

Oedema occurs during the inflammatory reaction phase of wound healing, though its influence extends beyond this phase and may result in lower wound tensile strength (Speer, 1979) and delay in the onset of the collagen synthesis phase of wound healing (Peacock and Van Winkle, 1976). It is produced by’ changes in microvascular permeability, by the breakdown of extravasated proteins (which increases tissue osmotic pressure), by increased capillary ground substance (preventing the rise in tissue tension which opposes further release of exudate) (Walter and Israel, 1972). One possible mechanism of action of the pulsed RF feilds might be to prevent the disaggregation of the mucopolysaccharides of ground substance which causes its increased fluidity and is one of the earliest features of the inflammatory response. In this way the fluid exudate (oedema) and free red blood cells from the damaged capillaries (bruising) would be less able to spread from the initial site of injury.

It is interesting in this context to note that attempts to model the effects of electric fields on connective tissue (Grodzinsky, 1983) have concentrated on the polysaccharides (GAGs) which are the main charge bearing constituents.

Diagram Bentall Study

FlGURE 1.

The height of the palbebral fissure on the active side is expressed as a percentage of the combined height of the palpebral fissures of both eyes.

Analysis of Blepharoplasty Results

Bruising and Eye opening data were analyzed using related samples – T tests and clinical assessments data was tabulated and evaluated by chi-square tests of association to evaluate the statistical significance. As explained in the publication, the three judges assessed and rated the extent of edema, bruising and sclera hemorrhage on each patient of both the left eye and the right eye as follows:

 

  • Right eye is significantly less than left eye
  • Right eye is less than left eye
  • No difference between right eye and left eye
  • Left eye is significantly less than right eye
  • Left eye is less than right eye

 

The assessment of each side left and right were combined. As explained by Dr. Bentall, data from 42 patients were entered into the analysis and as per table 1, data from 35 patients were actually used, seven patients did not show any significant difference in the assessment. Most studies using devices similar to ActiPatch™ Therapy such as TENS, NMS, etc. are conducted on 10-15 patients with an equal number being controls. Our study conducted with 81 patients, we believe is adequate and sufficient.

As explained earlier, each patient had one eye treated with the device and the other eye had a placebo. Patients therefore acted as their own control. Of the 42 patients, 21 had the right eye on treatment modality while the left eye was treated with Placebo. The other 21 had left eye treated while the right eye was treated with Placebo.

Figure 4 represents date from day 1. Only data from 9 patients were available since only 28 patients had worn the scale reference sticker. Of the 28 patients, 9 patients had significant assessment value. This data was used in the figure.

As explained in Figure 2, the data for day 3, 4, 5 includes 40 patients.

Table 1. Contains data on 35 patients that showed significant assessment. The remaining 7 patients showed significant assessment value. The data from 42 patients who completed the study was used. The ratings were of the extent of the edema, bruising and sclera hemorrhage. The three assessors examined the slides with the photographs of each eye and recorded a rating for each clinical sign on a specially designed form.

The data from this form was used in the table 1.

Figure 3, 4 and 5 quantifies bruising and the extent of the edema.

The data used one of three assessments being (?) that of a surgeon because the other two assessor’s data were in broad agreement with the findings. It was the opinion of the author and that of the referees that it was not necessary to duplicate the findings of the two other assessors.

The study as well as the difficulty in recruiting enough patients, the study is significant in spite of the relatively small number of patients assessed.

As detailed in the publication, all patients were recruited through a plastic surgeon (Dr. Nicolle). All patients undergoing bilateral Blepharoplasty who gave their informed consent were entered into the study.

There were no specific exclusion criteria other than informed consent. All patients receiving surgery to the upper lids and/or the lower lids were included.

Adverse events were assessed and documented but none were reported. Since all patients were using identical devices the likelihood of adverse events occurring were extremely small and unlikely. The major factor would have been infection and none was reported.

Use of Radio Frequency Pulsed Energy In the Control of Post-operative Reaction in Blepharoplasty. (Nicolle, FV. Bentall)

Attached are the Pilot Blepharoplasty Study of 21 patients, and a 42 Patient confirming Blepharoplasty study, the article published in Aesthetic Plastic Surgery, “Use of Radio-Frequency Pulsed Energy in the Control of Postoperative Reaction in Blepharoplasty” and Dr. Nicolle’s letter. The direct clinical evidence proves that the ActiPatch device reduces both bruising and edema. Since Blepharoplasty involves removal of excess skin and fat from the upper or lower eyelids, where the skin has low tension, postoperative bruising and swelling are inevitable. Blepharoplasty is therefore a good clinical model for evaluation of the effects of the ActiPatch device. In the study, for three days following surgery, bilateral Blepharoplasty patients wore a pair of specially adapted ActiPatch devices with antennae shaped to form lens-less spectacles with both and active and placebo side. Neither the patient nor the physician could detect the active frame. The results show that the areas of bruising and the observable signs of swelling were statistically lower by more than twenty-percent (20%) on the side that received active treatment as opposed to the placebo treated eye lid.

Abstract

This is a preliminary report of the use of a device to apply small pulses of radio-frequency energy to surgical wounds in order to improve wound healing. The device was applied to one eye in 21 patients who underwent bilateral blepharoplasty. There were no device related complications. In 11 patients, edema and ecchymosis were noticeably less on the treated side within 24 hours of surgery. In 6 patients, ecchymosis and swelling were so slight that no difference between treated and untreated sides was visible. Two patients were noticeably worse on the treated side. Further studies will be conducted.

Key words

Blepharoplasty – Wound healing – Instrumentation

The first mention in the literature of the use of electricity for healing purposes was possibly Adams in 1799. He recalls the work of Dr. Adam Birch of St. Thomas’s Hospital, London, in the 1780′s using Faradic stimulation to assist in the relief of pain and inflammation in a variety of skin conditions [I]. D’Arsonval, a French physiologist in the 1880′s, first suggested that a biological system would interact at a molecular and ionic level with electromag­netic fields of various frequencies and encouraged the use of shortwave diathermy for physiotherary [2]. In more recent times Ginsberg [7] and Fenn [5] have demonstrated that a pulsed 27.12 megahertz device can aid in the resolution of soft tissue swelling and bruising. In the 1970′s both Wilson [9] and Bentall [3] confirmed that these observations ere reproducible in clinical practice. Other means have also been developed of electrically stimulating me repair in non-unions, Bassett [2], Fukada [6], and Watson [8] used differing devices, all of which their final interaction with the tissues induce a current in the tissues secondary to the electric and magnetic field. These devices are large and expensive.

In the past 5 years, a small portable device has been developed by Bentall which has been used in studies on secondary wound healing and on rat abdominal wall tensile strength measurements. These controlled studies, using a placebo device as a control, demonstrated that there was enhance­ment in the acute wound healing process of 20-30% in these models. The human wound healing study using histological criteria pointed also to a more proficient wound healing process with less pleomorphism in the basal cell layer; almost normal palisading of the basal cells, which is not normally seen in wounds healing from secondary intention: and an almost normal height of re-epithelization compared with the thinned epithelium in the placebo group. These findings encouraged the present study to be undertaken to ascertain the possible clinical role of such a device.

The study reported here was designed to assess the possible benefit of such treatment to patients undergoing cosmetic surgery of the face. Blepharo­plasty provided an excellent model, since the lids on each side can be compared for differences in the amount of ecchymosis and edema.

Material and Methods

The device itself consists of a small oscillator tuned to 27.12 megahertz with a timer switching the oscillator so that small pulses of radio-frequency energy are emitted from the single turn coaxial coil. The shape of the pulse is square and is 100 ? sec long, there being 1,000 pulses per second. The power is from a small nickel-cadmium rechargeable 3.5 volt DC battery which draws 0.5 ma: the unit may be used for 5 days without recourse to recharg­ing. The area of the coil is approximately 6 cm in diameter.

Fig. 1. A patient who underwent upper and lower blepharoplasty on both right and left eyes. The right eye was treated with Bentall’s device and illustrates the typical response noted in 11 out of 13 cases where sufficient ecchymosis and edema existed for comparison. In this case, although ecchymosis is similar In both eyelids, the degree of edema is obviously greater in the untreated left eye. This difference is most obvious 24 hour, postopera­tively, but the relative improvement is apparent through­out the period of observation. (A) One day postoperatively, (B), Three days postoperatively, (C) Six days postoper­atively

In order to adapt this device to fit over the eyelid region, 2 wire loops were designed in the shape of a spectacle frame which can then be held in place with light padding and a 2 in crepe bandage. Only 1 loop is electrically active, the other providing a control. This device was applied at completion of surgery and removed after 24 hours. The device showed no indication as to which side was active and this was only known to the manufacturer.

For the purpose of the preliminary report, 21 consecutive cases of blepharoplasty were treated. Photographs were taken 24 hours postoperatively when the bandage was removed, after 3 days when the sutures were removed and after 6 days follow­-up. Some cases were of upper and lower blepharo­plasty, others of one set of lids only (fig. D) Some were operated on under local anesthesia and others under general. No attempt was made to subdivide this group since a study of all the patients in a consecutive series was considered to be the most valid basis for comparison.

Results

Twenty-one patients were studied and the postoperative course of all of them was uncomplicated by any contributory factors such as vomiting, coughing bouts, or trauma which might have influenced the result. Two cases were excluded because of dis­placement of the dressings by the patients. No patient complained of any unusual pain locally or headaches that might have been interpreted as related to the electrical treatment.

In 6 cases, ecchymosis and swelling was so slight that no difference was visible between the treated and untreated sides. In II cases, improvement was apparent, which was most obvious at 24 hours when treatment was ended. At this point edema, and to a lesser extent ecchymosis, was distinctly less on the treated side, and this improvement continued to be apparent after 6 days when the period of early follow-up ended. Two cases were judged to be worse on the treated side.

Discussion

A patient’s most immediate concern following facial cosmetic surgery is whether they will experience much bruising, swelling, or pain and how long it will take to recover to a point when it will pass unnoticed during social contact. This series is small, but the results are so encouraging that report­ing it seems justified. Of course, the study will continue and a much larger number of cases will be added to this study in the immediate future.

We are also now employing a similar device for incorporation in face and neck lifts, which is identical electrically but has two larger wire loops to cover the neck and sides of the face. Devices such as Bentall’s have immense possible benefits to plastic surgery cases, not only in cosmetic cases, not only in cosmetic cases but in so many situations where the rate of healing and reduction of edema and ecchymosis are of considerable importance. We look forward to reporting later on a much expanded series.

References

I. Adams G: An Essay on Electricity. Explaining Principals of That Useful Science and Describing the Instruments. 5th Edition. Dillion and Co, 1799, pp 482-575

2. Bassett CAL. Pawluk R1. Pills AA: Augmentation of Bone repair by inductively coupled electromagnetic fields. Science 184:575, 1974

3. Bentall, RHC.Lekstein, HB. A Trial involving the use of pulsed electromagnetic therapy on children undergoing orchidopexy. Kinderchirurgic 17 (no 4) Novem­ber, I975

4. D’Arsonval A: New method of electrical simulation/ exultation of nerves and muscles. CR Acad Sci (Paris) 92: 1520, 1881

5. Fenn JE: Effect of pulsed e!ectromagnetic energy (Diapulse) on experimental haematomas. Canad Med Assoc J 100:261, 1969

6. Fukada, ,

7. Ginsberg, AJ: A description of myoathermic short wave apparatus with clinical applications. NY Acad. Med October 14, 1940

8. Watson J, Downes EM: The application of pulsed magnetic fields to the stimulation of bone healing in healing. Jpn J Appl Phys 17:215, 1978

9. Wilson DH: Treatment of soft tissue injuries by pulse electrical energy. Br Med J 2:269. 1972