Within-patient Controlled Study Research Articles

A Prospective, Within-Patient Controlled Study to Compare the Ability of the Non Adherent Drawtex® Hydroconductive Dressing to a Transparent Polyurethane Film Dressing (Standard of Care) on the Healing of Split-Thickness Skin Graft Donor Sites*

Background: Dressing of split-thickness skin graft donor sites can be traumatic for the patient. The most advanced and expensive dressings have been compared to the most basic of dressings, with little or no consensus and an unpersuasive level of evidence. We aimed to determine the efficacy of the locally manufactured non-adherent, hydroconductive Drawtex® dressing and compare it to our current standard-of-care dressing, a thin transparent polyurethane film, in the healing of split-thickness donor sites. Methods: This prospective, within-patient controlled study included 27 adult participants, each with two split-thickness skin donor sites. The 54 donor site wounds were compared with regard to time to re-epithelialisation, perceived pain and healed wound quality. Results: By day 5, complete healing of donor site wounds, defined as >90% of epithelialized surface, was significantly higher in the hydroconductive dressing group compared to the polyurethane film group (22.2% and 3.7%, respectively; p < 0.0001). The hydroconductive dressing-treated donor site wounds were significantly less painful at 24-hours, 48-hours and 7-days post-operatively, and had fewer complications and superior wound healing quality. Conclusion: We have demonstrated that the relatively cheap and readily available dressing made locally in South Africa, Drawtex® is at least as safe, and potentially superior in wound healing, when compared to our current standard-of-care dressing.

Focal impulse and rotor modulation as a stand-alone procedure for the treatment of paroxysmal atrial fibrillation: A within-patient controlled study with implanted cardiac monitoring

Focal impulse and rotor modulation (FIRM) has been proposed as a novel approach for the treatment of atrial fibrillation (AF). This study aimed to investigate the efficacy of FIRM as a stand-alone procedure for the treatment of paroxysmal AF. A total of 27 patients with paroxysmal AF underwent sequential biatrial computational mapping. Sites with repetitive centrifugal or spiral reentry-like activity were considered to be AF-sustaining sources and targeted by irrigated radiofrequency (RF) ablation. All patients were seen in the outpatient clinic after 1, 3, and 6 months and thereafter every 6 months. Cardiac monitors were implanted 3 months before ablation in 17 patients (63%). Repetitive activity interpreted as sustained AF sources was found in all patients, with an average of 3.0 ± 1.1 sources located in the left atrium and 0.6 ± 0.6 sources in the right atrium. The majority of sources were rotors (95%). The total source-ablation radiofrequency time was 20.0 ± 9.0 minutes. At 15.2 ± 3.9 months of follow-up, the prespecified end point of <1% AF burden (outside a 3-month blanking period) was achieved in 2 of the 17 continuously monitored patients (12%). Of all the 27 patients who underwent FIRM, AF episodes of ≥30 minutes were recorded in 23 (85%), while AF episodes ≥60 minutes were recorded in 21 patients (78%). This study suggest that biatrial ablation of localized patient-specific sources alone, as detected by this method, is not sufficient to reduce paroxysmal AF burden in the majority of patients.

Double Pass 595 nm pulsed dye laser at a 6 minute interval for the treatment of port-wine stains is not more effective than single pass

Pulsed dye laser (PDL) is the first choice for treatment of port wine stains (PWS). However, outcome is highly variable and only a few patients achieve complete clearance. The objective of the study was to compare efficacy and safety of single pass PDL with double pass PDL at a 6 minute interval. We conducted a randomized within-patient controlled study on PWS resistant to multiple single pass PDL treatments. In each patient two similar PWS areas were randomly allocated to PDL treatment (595 nm, 7 mm spot size, 1.5 mseconds pulse duration) using, as a control treatment, a single pass (12 J/cm(2)) or, as a new treatment, a double pass PDL (11 J/cm(2), second pass 6 minutes after the first pass). Both test areas were treated two times, 8 weeks apart. PWS clearance was assessed by two blinded dermatologists, and by color measurement (L*a*b) using reflectance spectroscopy, at 3 months follow-up. Sixteen out of 17 included patients completed follow-up. The mean number of treatments before inclusion was 15. Overall color assessed by spectrophotometer showed no improvement for either single or double pass PDL. Blinded Physician Global Assessment and Patient Global Assessment showed a high variability in outcome, with mostly only moderate improvement of the PWS for either single pass or double pass PDL. Furthermore, there was no significant difference in any of the outcomes between single pass and double pass PDL. At the chosen settings and after two treatment sessions, double pass PDL at a 6 minute interval does not result in improved clearance of PWS as compared to single pass treatment.

Excimer laser vs. clobetasol propionate 0·05% ointment in prurigo form of atopic dermatitis: a randomized controlled trial, a pilot

Recent findings have established the 308-nm xenon chloride excimer laser (EL) as a new option in the area of ultraviolet (UV) B phototherapy. As this laser enables high radiant exposure of narrowband UVB and precise targeting of affected skin, it appears to be a promising treatment for the prurigo form of atopic dermatitis (AD). To investigate the efficacy and safety of the EL compared with clobetasol propionate (CP) in the prurigo form of AD. In a prospective randomized within-patient controlled study, 13 patients with a prurigo form of AD were randomized to receive EL on one side and topical CP on the other side. Laser treatment was performed twice a week for 10 weeks. Clinical responses were evaluated using Physician Assessment of Individual Signs, Physician Global Assessment, Patient Global Assessment and photographic documentation. Histopathological changes were evaluated and duration of remission was monitored during a 6-month follow-up period. Both treatments resulted in a significant improvement of all outcome measures after 10 weeks of treatment. During follow up, the EL showed more improvement compared with CP. Histopathology demonstrated marked decrease of epidermal thickness and inflammatory infiltrate at the EL-treated sites. No significant side-effects occurred. This study suggests that the EL can safely and effectively be used in the treatment of the prurigo form of AD. For the long term, the EL might be a good alternative to topical corticosteroids and an option in case of therapy-resistant patients.

Proliferation of fibroblasts cultured on a hemi-cellulose dressing

In recent times, hemi-cellulose dressing (HD) has been used clinically with satisfactory rates of success [Melandri D, De Angelis A, Orioli R, et-al. Use of a new hemicellulose dressing (Veloderm) for the treatment of split-thickness skin graft donor sites A within-patient controlled study. Burns 2006 Dec;32:964-72.]; however, the effect of cellulose dressings on the wound-healing process is unclear due to paucity of experimental data. This study aimed to determine the adhesion and proliferation of human skin fibroblasts, which were cultured in vitro using the explant technique, on HD. Cells were seeded onto HD discs and evaluated for cell adhesion and cell proliferation after 7, 14 and 21 days. Fibroblasts displayed 70% adhesion to HD after 24h. The HD discs seeded with a density of 5x10(4) cells per well showed a proliferation rate of 12% on day 7, 30% on day 14 and 75% on day 21. The results demonstrated that HD can sustain fibroblast proliferation--a highly desirable characteristic for an ideal skin substitute.

Pupillary changes among Nigerian adults following the instillation of Garcinia kola nut extracts: multicentric studies

A multi-centre, open, within-patient controlled study was performed on 106 adult volunteers to investigate the effects of Garcinia kolanut extracts on the pupillary sizes. 106 participants in three Nigerian Ophthalmic Centres with no pupillary defects and associated ocular or systemic co-morbidities had their pupillary diameters measured at 0, 15, 30 and 45 minutes respectively with a pupillometer (Neuroptics model # 586009). Using the left eyes as control, Garcinia kolanut extract was instilled into the right eyes at 15 minutes intervals. There were 63 females and 43 males ranging in age from 18 to 58 years with the mean age of 34.9 years. Average pupillary diameter measured among participants was 4.1 - 8.4 mm with the mean value of 6.0 mm prior to garcinia kola nut extract instillation. There was a gradual reduction in the baseline pupillary size with age in years at 0.2mm per decade without garcinia extract instillation. There was a significant higher baseline pupillary diameter in males than females with males and females mean values of 6.29mm (6.00 - 6.56mm) and 5.85mm (5.60 - 6.11mm) in the right eye (p=0.026) and mean pupillary diameters 6.16mm (5.90 - 6.42mm) and 5.80mm (5.56 - 6.04mm) in the left eyes (p=0.05) respectively. There were consistent significant miosis in the right eyes with instilled Garcinia kola nut extract compared to the left eyes at 15, 30 and 45 minutes (p=0.0000). 4% Garcinia kola nut extract drop has a transient miotic effect on human pupils not sustainable for more than 45 minutes.

Use of a new hemicellulose dressing (Veloderm ®) for the treatment of split-thickness skin graft donor sites : A within-patient controlled study

A multi-centre, open, within-patient controlled study was performed on 23 adult burnt patients to investigate the effectiveness, safety and tolerability of Veloderm ® in comparison with Algisite M™ and Jaloskin ® in split-thickness skin graft donor site care. The areas dressed with Veloderm ® completely healed within 10–13 days in a significant higher proportion than the other two dressings (47.6% for Veloderm ® versus 26.3% for Algisite M™ and 10% for Jaloskin ®, P < 0.03), showing during the whole study less incidence of exudates and of peri-lesional erythema. The aesthetic outcome of the treated lesions after healing was significantly better for Veloderm ® ( P = 0.0016). Veloderm ® and Jaloskin ® required very few renewals of the medication during the first week of treatment, while Algisite M™ needed several multiple re-dressings. Veloderm ® was judged better than the other two treatments as far as the acceptability ( P < 0.001), ease of use ( P < 0.001) and efficacy ( P < 0.00001). Both pain during application or at removal of dressings and local infections were negligible with all treatments. No scars were formed in any skin donor site. In conclusion Veloderm ® is a safe and effective dressing for the re-epithelialization of the skin graft donor sites: it showed higher activity than the other two compared dressings.

Evaluation of irritation and sensitisation of two 50 μg/day oestrogen patches

Objectives: To comparatively assess the irritation and sensitisation of the Estradot ® transdermal oestrogen patch, in healthy postmenopausal women, using the Menorest ® transdermal oestrogen patch, as a comparator. Methods: In an open-label, single-centre, randomised, active-treatment, within-patient controlled study, 208 healthy postmenopausal women, age range 40–70 years, received and completed simultaneous treatment with a 5 cm 2 (50 μg/day) oestradiol patch (Estradot) and a 14.5 cm 2 (50 μg/day) oestradiol patch (Menorest). The treatment was given for 72 h, then 96 h, for eight successive applications during an induction phase, and for 72 h during a challenge phase. There was a 14-day resting period between phases. Skin irritation (measured by erythema on a scale of 0–4), topical sensitisation, patch adherence and local skin reaction, were assessed and recorded immediately before or after removal of each patch, as appropriate. Results: Most patients experienced a significant difference in irritation with Menorest than with Estradot ( P<0.0001) at the end of the induction phase. Patch loss was also significantly higher for Menorest as compared to Estradot ( P=0.0253) at the end of the induction phase. Most incidences of erythema were classified as slight (score of 1), and there was no significant difference in the percentage of topical sensitisation, or in the incidence of local skin reactions between Estradot and Menorest. Patch loss was low for both systems. Conclusions: Estradot demonstrates reduced skin irritation, superior adhesion and a lower rate of patch loss compared to Menorest.