Persons were not considered for
enrolment in the study if any of the following exclusion criteria were present: ■ Severe generalised diseases ■ Allergic diseases ■ Skin diseases (dermatosis) ■ Chronic contagious diseases in active stage (e.g. herpes, hepatitis)
■ Inflammatory processes of the skin and sub-skin structures
■ Endocrine diseases ■ Pregnancy or breast-feeding ■ Vessel diseases of differing aetiology;
■ Anticoagulant or aspirin intake ■ Mental health conditions, inadequate motivation. The hydrophilic gel was injected under strict aseptic and antiseptic conditions. The patients were followed-up over a 12-month period in line with the control terms: immediately after the procedure; on the third day following treatment; 7 days post-treatment; and at 3-, 6- and 12 months post-treatment. Three hundred sixty-seven
subjects were enrolled on the study and divided into 12 groups, depending on the area of facial injection. They underwent a total of 432 treatment procedures (Figure 1). The most frequent procedures
were to the nasolabial folds (127 procedures; 29.4%), periorbital folds (82 procedures; 19%), and perioral wrinkles (61 procedures; 14.1%). Two hundred and sixty-one
patients (60.4%) were followed-up 3 months after the procedure; 26.6% (n=115) to 6 months; and 19% (n=82) to 12 months. The results indicate the low interest of patients in the doctor’s follow-up and at the same time, the low frequency of adverse effects over a long-term period.
Safety assessment Patient safety was estimated by
the rate of local reactions and side-effects from the beginning of treatment and during the period of observation. Figure 2 summarises the
35 30 25 20 15 10 5 0
Blood spots
Diapedetic haemorrhage
Bruises Oedema
Change of skin colour, pigmentation
Reddening Itch Pain Tingling inflammation Infection, Immediately after the plastic procedure
After 3 days After 7 days
Loss of sensitivity
Induration
Nodule
distribution of filler
Figure 2 Percentage of local reactions registered immediately after the procedure, and at 3- and 7 days post-treatment
frequency of local reactions observed immediately after the procedure and at 3 and 7 days post-treatment. The highest percentage of local reactions among registered cases was oedema
(immediately
post-treatment = 31.9%; at 7 days = 0.7%); diapedesis haemorrhage (immediately post-treatment = 10.9%; at 7 days = 1.4%); and reddening (immediately post-treatment = 8.3%; at 7 days = 0.7%). Other local reactions (e.g. itching, pain, tingling, infiltration) decreased by one tenth of a percentage at day 7. No serious side-effects were
observed during the 12-month follow-up: 46.3 % of patients were observed with one local reaction; 13% had two concurrent local reactions; and 2.8% had three concurrent local reactions. The most frequent side-effects
after the procedures were recorded as headache (1.2%), weakness (0.7%), low-grade fever (0.5%), and chill, cold, infection/inflammation (0.2%).
Efficacy assessment Efficacy of the procedures was
evaluated using three assessment scales: ■ Depth of Wrinkles Scale (DWS) — assessed by the doctor only
■ General Aesthetic Improvement Scale (GAIS) — assessed by both doctor and patient
■ Scale of Psychological Comfort and Goal Achieving (PCGAS) — assessed by the patient only. The 100% effect was observed at more than 12 months (doctor’s
The patient monitoring time
Effectiveness indicators
Wrinkle evaluation (doctor’s evaluation)*
GAIS (doctor’s evaluation)**
GAIS (patient’s evaluation)***
PCGAS (patient’s evaluation)
The evaluation of the duration of the effect (doctor’s evaluation)
The evaluation of the duration of the effect (patient’s evaluation)
Immediately after the
procedure 1.71±0.03
- - 0.7 - - In 3 days 2.12±0.05 1.45±0.04 In 7 days In 3 months In 6 months In 12 months 2.17±0.04 2.3±0.07 2.15±0.05 1.57±0.06 1.69±0.06 1.65±0.03 1.35±0.04 1.55±0.05 0.75 - - 0.75 - - * The results are provided in the form of confidence intervals (with P=0.95).
** At 12 months, the patients (due to physiological reasons) wanted to perform additional plastic surgery procedures in order to maintain the effect (most often in other areas previously not treated with filler injection).
*** As immediately after the procedure the presence of minor side-effects (reddening, oedema) distorted the evaluation, the general positive aesthetic effect was evaluated starting from the third day post-treatment.
Figure 3 Effectiveness indicators of hydrophilic gel application over a 12-month follow-up
evaluation), while DWS = 2.16 ± 0.09, GAIS = 1.67±0,02 (doctor), and GAIS = 1,57±0.04 (patient). The results are provided in the form of confidence intervals (P=0.95) 12 months after the procedure. PCGAS was 0.67 after 12 months. The evaluation of the effectiveness of facial procedures is presented in Figure 3.
Conclusions Hydrophilic gel (composed of 98%
of 0.9% physiologic solution of
sodium chloride and 2% of polyamide) was observed to be an effective and well-tolerated (safe) dermal filler in facial aesthetic surgery. The patient safety and efficacy results demonstrated in this study show that hydrophilic gel can be an attractive option for facial plastic surgery both for the patients and doctors taking into consideration its long-lasting effect and natural results.
1. Data on file, Biomatrix, Ltd. 1.61±0.05 0.65 +++ +++ 1.54±0.05 0.7 +++ +++ 2.16±0.09 1.67±0.02 1.57±0.04 0.67 +++** ++(+)
Uneven
Treatment to the nasolabial folds (A) before and (B) after treatment with Aquafilling
prime-journal.com | Product Portfolio ❚ 27
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