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Biomedical subjects

Murad Alam

Publications and source records attributed to Murad Alam.

At least 19 recordsLinked to original sources
PubMed2007

Technique for calcium hydroxylapatite injection for correction of nasolabial fold depressions.

BACKGROUND: Injectable calcium hydroxylapatite is a soft-tissue augmentation material that is used off-label for facial augmentation, including repletion of depressed nasolabial folds. OBJECTIVE: We sought to assess the safety of calcium hydroxylapatite injection for correction of nasolabial fold depressions. Specifically, we sought to obtain a quantitative assessment of injection-related adverse events using a reproducible placement technique with long-term follow-up. METHODS: We conducted an open-label, single-center prospective study using reproducible technique with 1- to 1.5-year follow-up. All patients were treated with infraorbital nerve blocks. Then, parallel linear threading technique using 27-gauge/1.25-in needles was used to place 1 to 2 mL of injectant at the dermal subcutaneous junction into each pair of depressed folds. A triangular array of injectant was deposited under the melonasal junction. At follow-up at 2 to 3 weeks and at 1 to 1.5 years, respectively, patients were asked to report and characterize injection-related redness, swelling, bruising, nodule or granuloma formation, asymmetric correction, textural change, hypersensitivity reactions, degree of correction remaining, and overall satisfaction. In addition, patients who had received other injectable soft-tissue materials were asked to compare these with calcium hydroxylapatite in terms of risk profile and longevity of effect. RESULTS: In all, 22 patients were treated and complete follow-up data were obtained from 18. Of the 18 patients, all reported at least mild postinjection redness and swelling, which abated within 1 to 5 days. Bruising was reported by fewer than half, and resolved within 4 to 10 days. Palpable but not visible nodules were reported by 2 of 18 patients; these resolved within 3 months of injection. Asymmetric correction, textural change, granulomas, and hypersensitivity reactions were not reported. In all, 14 of 18 patients reported that cosmetically significant correction lasted longer than 1 year. Two thirds of injected patients who had received other fillers for nasolabial fold correction preferred calcium hydroxylapatite, with the primary reason being increased longevity of effect. LIMITATIONS: There was a lack of objective outcomes measures. CONCLUSIONS: When a consistent, defined injection technique is used, injectable calcium hydroxylapatite appears to be a well-tolerated soft-tissue augmentation material for correction of nasolabial fold depressions. A long duration of effect may make this material particularly desirable for some patients.

Adult↗
PubMed2006

Aesthetic and functional efficacy of subcuticular running epidermal closures of the trunk and extremity: a rater-blinded randomized control trial.

OBJECTIVE: To ascertain whether subcuticular epidermal closures of elliptical excisions of the trunk and extremities result in better functional and cosmetic outcomes than simple running epidermal closures of the same sites. DESIGN: Randomized controlled trial, with allocation of epidermal closure of elliptical excisions to 4 arms, including 1 control arm (simple running polypropylene sutures removed after 14 days) and 3 experimental arms (subcuticular running polypropylene sutures removed after 14 days, subcuticular running polypropylene sutures left in place, and subcuticular running polyglactin 910 sutures left in place). All experimental interventions were preceded by deep dermal closure with simple interrupted polyglactin 910 sutures. Interventions were delivered by 3 surgeons, who underwent 2 training sessions to minimize intersurgeon technique variability. SETTING: Institutional referral practice providing ambulatory care in an urban environment. PATIENTS: A consecutive sample of 36 adult patients (ages 18-65 years), each referred for concurrent elliptical excision of at least 2 clinically atypical nevi of the trunk and/or extremity, were included in the study. MAIN OUTCOME MEASURES: Primary outcome measures obtained at 3 and 9 months included scar width in millimeters and blinded observer ordinal scale assessment of overall scar appearance. Secondary outcome measures included ratings on the standardized Vancouver Scar Scale and the Hollander Scar Scale; an additional nonstandard item was added to assess pruritus. RESULTS: No difference among groups was found in scar width at 3 or 9 months. Differences among groups were detected in overall scar appearance (3 months, P<.001; 9 months, P<.001), vascularity (3 months, P = .001; 9 months, P<.001), excessive distortion (3 months, P = .04; 9 months, P = .02), contour irregularity (3 months, P<.001), and edge inversion (3 months, P = .01). The best overall appearance was with a subcuticular running polyglactin 910 suture left in place, and the next best was with a subcuticular running polypropylene suture left in place; differences across groups persisted but decreased in intensity at 9 months. A secondary analysis that matched high-tension anatomic sites (back and lower leg), and high and moderate tension sites (also chest and shoulder) yielded the same main effects and mostly the same results in pairwise comparisons. CONCLUSION: While scar width does not appear to vary significantly based on choice of epidermal closure, bilayered closures of the trunk and extremity have better overall appearance and less associated erythema at 3 and 9 months after surgery with the use of a subcuticular running polyglactin 910 suture left in place.

Abdomen↗
PubMed2006

Safety of radiofrequency treatment over human skin previously injected with medium-term injectable soft-tissue augmentation materials: a controlled pilot trial.

BACKGROUND AND OBJECTIVES: Several soft-tissue augmentation materials are now available for reduction of nasolabial fold creases and perioral rhytides. Nasolabial folds and perioral rhytides can also be improved by skin tightening delivered by non-ablative radiofrequency (RF) treatment. The purpose of this study was to assess the safety of RF treatment over skin areas recently injected with medium-term injectable soft-tissue augmentation materials. STUDY DESIGN/MATERIALS AND METHODS: Five subjects were assigned to the experimental arm (augmentation materials plus RF) and one to the control arm (augmentation materials alone). Each subject received injections of 0.3 mL of hyaluronic acid derivative (Restylane) and calcium hydroxylapatite (Radiesse) 3 cm apart on the upper inner arm. Two weeks later, two non-overlapping passes of RF (Thermage ThermaCool TC) were delivered at 63.5 setting with medium-fast 1.5 cm2 tip over injected sites in all of the experimental subjects. Punch skin biopsies were obtained 3 days later from each of the two injection sites on each subject. RESULTS: Light microscopy and digital photomicrographs obtained at low, medium, and high power showed no difference between filler materials in experimental and control subjects. In both cases filler was evident at the deep dermal-subcutaneous junction. Nodule formation, foreign body extravasation, or hemorrhage/clot was not observed grossly or histologically. Subjects and physicians did not report any difference in signs and symptoms between the experimental and control arms. Slightly increased transitory pain was noted when RF was delivered over filler versus over normal skin. CONCLUSION: Applying RF treatment over the same area 2 weeks after deep dermal injection with hyaluronic acid derivatives or calcium hydroxylapatite does not appear to cause gross morphological changes in the filler material or surrounding skin. Further studies with different parameters are necessary to confirm these findings.

Adult↗
PubMed2006

A quality rating scale for aesthetic surgical procedures.

BACKGROUND: Cosmetic dermatologic procedures offer the promise of visible aesthetic enhancement with minimal risk. While in recent years the number of available procedures has proliferated, there are few objective methods for evaluating the relative quality of these procedures for particular indications or specific patients. OBJECTIVE: (A) To develop a simple, easy-to-use numerical rating scale to assess the quality of cosmetic surgical procedures on a range of parameters pertaining to clinical efficacy and patient satisfaction; (B) to statistically validate the discriminative value of this rating scale. METHODS: (A) Patient and physician interviews were performed to elicit a list of factors that may collectively characterize the clinical efficacy and patient tolerability of cosmetic dermatologic procedures. A 0-100 point rating scale was developed based on these factors, with the face-validity of this scale checked by a group of patients and physicians; (B) Statistical analysis of the questionnaire was performed by asking 15 expert cosmetic dermatologic surgeons to use it to rate 23 common cosmetic dermatologic procedures, and analyzing the results. RESULTS: (A) An easy-to-use scale was constructed to assess the quality of cosmetic dermatologic procedures by rating the associated cost, risk, time (procedure and recovery), discomfort, results, and longevity of benefit. A "physician adjustment factor" was used to further increase the relevance of this 0-100 point scale for specific patients; (B) Repeated-measures analysis of variations (ANOVAs) performed on the data from the survey of experts demonstrated that this scale can be used to discriminate between common dermatologic procedures. The differences in mean subscores and total scores among procedures grouped by anatomic site and target lesion-type were significant at the level of P < .05. LIMITATIONS: Patient preferences exogenous to the rating scale may increase or decrease the suitability of specific procedures. CONCLUSIONS: Common cosmetic dermatologic procedures are of uniformly high quality, as per expert ratings on a systematic measure. This quality rating scale appears statistically valid and robust, given that expert raters assigned similar ratings to the same procedures but mean ratings were different across procedures. In the future, this quality rating scale can be used to assess novel interventions, and to help dermatologic surgeons faced with patient concern to optimally select among alternative procedures for a given indication.

Botulinum Toxins, Type A↗
PubMed2006

Sterility assessment of multiple use botulinum A exotoxin vials: a prospective simulation.

BACKGROUND: A preponderance of evidence now indicates that storage of reconstituted botulinum toxin solution for longer than the 4 hours recommended by the manufacturer does not result in loss of effectiveness. OBJECTIVE: Then purpose of this study was to assess whether serial re-extraction of reconstituted botulinum toxin solution from vials undergoing prolonged storage is associated with increased risk of microbial contamination. METHODS: Consecutive 100-U vials of botulinun A exotoxin were reconstituted with 2.5 mL each of normal saline with preservative (benzyl alcohol). Within 1 week after reconstitution, each vial was used to treat 1 to 3 patients, for a total of 60 to 80 U used. Thereafter, each vial was stored in a plastic kidney basin in an unlocked, multiuse medication refrigerator. Two weeks later, a randomly assigned nurse removed the vial from the refrigerator and withdrew and discarded 0.1 mL (5 U) using the same technique used for therapeutic extractions. Iterations of this withdrawal and discarding procedure were continued until a 0.1-mL aliquot could not be withdrawn without prying off the metal cover. Once this threshold was reached, the vial was sent to the microbiology laboratory for sterility testing using a thioglycolate broth. RESULTS: In all, 127 vials were handled per protocol. On average (mean), vials underwent 4.5 access procedures, including 1.6 therapeutic extractions for a total of 76 U removed during a period of 7 weeks. Sterility analysis with thioglycolate broth indicated no evidence of contamination. LIMITATIONS: Preservative-containing saline was used for reconstitution. CONCLUSION: Routine refrigerator storage of medication vials containing reconstituted botulinum toxin does not result in microbial contamination of the contents even after serial re-extraction of solution from these vials, and after handling of such vials by multiple personnel. Storage and subsequent reuse of botulinum toxin appears safe for at least 7 weeks after reconstitution.

Botulinum Toxins, Type A↗
PubMed2006

Clinical effect of a single pulsed dye laser treatment of fresh surgical scars: randomized controlled trial.

BACKGROUND: Pulsed dye laser has been used to decrease erythema and telangiectasia associated with scars, including surgical scars. There is limited evidence indicating improved surgical scar appearance if pulsed dye laser treatments are commenced immediately at the time of suture removal. OBJECTIVE: To determine whether a single one-pass pulsed dye laser treatment at the time of suture removal can improve the appearance of surgical scars. METHODS: Randomized controlled trial enrolling 20 patients (complete data for 17 patients) at two geographic sites, with blinded ratings of pre- and post-treatment photographs obtained at various time points. Included patients underwent elliptical excision for atypical nevi of the trunk and/or extremities, with at least one resulting scar of at least 5 cm in length or two scars of at least 2.5 cm in length. For each patient, each scar or half-scar (if a larger scar was used) was randomized to treatment or control groups. Treatment scars received a single one-pass treatment with a 595 nm pulsed dye laser (Vbeam, Candela Corporation, Wayland, MA, USA) at the time of suture removal (ie, 2 weeks after excision) at the following parameters: 7 J/cm2 fluence, 7 mm spot size, 1.5-millisecond pulse duration, and 30-millisecond spray, 20-millisecond delay of dynamic cooling. The treatment area included 1 cm on either side of the scar, and the round laser spots were overlapped 10%. Control scars were not treated with laser. RESULTS: Immediate purpura was induced from the laser treatment Six weeks after laser treatment, no significant difference was found in the clinical appearance of surgical scars treated with a single pulsed dye laser treatment on suture removal day versus those surgical scars not treated with laser. Parameters on which no significant difference was found included visibility of incision, erythema, hyperpigmentation, hypopigmentation, induration, and atrophy. Both sets of scars improved over time. CONCLUSIONS: A single pulsed dye laser treatment at the time of suture removal does not appear to have a beneficial effect on clinical scar appearance. The point of minimal benefit for such laser treatments may lie somewhere between one and three treatments.

Adult↗
PubMed2006

Patient satisfaction and reported long-term therapeutic efficacy associated with 1,320 nm Nd:YAG laser treatment of acne scarring and photoaging.

BACKGROUND AND OBJECTIVE: Nonablative laser treatments have become increasingly used for the treatment of acne scarring and photoaging. While nonablative laser treatments are more convenient and relatively safer than ablative laser resurfacing, efficacy and patient satisfaction with the level of improvement of textural abnormalities in acne scarring and rhytids associated with photoaging needs further study. DESIGN/MATERIALS AND METHODS: Structured interviews were performed with 34 patients from a referral-based academic practice who each previously received a series of 6 monthly treatments with a 1,320 nm neodymium:yttrium-aluminum-garnet (Nd:YAG) laser for treatment of acne scarring or photoaging. Topical anesthesia was applied 1 hour before each treatment. Patients were interviewed at least 3 months after cessation of treatment (range 3-12 months). RESULTS: Patients tolerated the treatments well. Combined results for acne scarring and photoaging patients were as follows: (a) patient satisfaction with treatment was rated at 62%, and (b) textural improvement was reported at 31% at the end of the six treatments, and 30% at the date of interview. When results were stratified by diagnosis, patient satisfaction was slightly higher for treatment of acne scarring than for photoaging. Overall degree of improvement on a 1-10 scale was 5.4 for acne scarring and 3.8 for wrinkling. CONCLUSION: Nonablative treatment with the 1,320 nm Nd:YAG laser induced significant patient-reported improvement in both acne scarring and photoaging. The majority of patients reported satisfaction with the degree of improvement.

Acne Vulgaris↗
PubMed2006

Frequency of use of suturing and repair techniques preferred by dermatologic surgeons.

BACKGROUND: There are many closure techniques and suture types available to cutaneous surgeons. Evidence-based data are not available regarding the frequency of use of these techniques by experienced practitioners. OBJECTIVE: To quantify, by anatomic site, the frequency of use of common closure techniques and suture types by cutaneous surgeons. METHOD: A prospective survey of the members of the Association of Academic Dermatologic Surgeons that used length-calibrated visual-analog scales to elicit the frequency of use of specific suture techniques. RESULTS: A response rate of 60% (61/101) indicated reliability of the received data. Epidermal layers were closed most often, in descending order, by simple interrupted sutures (38-50%), simple running sutures (37-42%), and vertical mattress sutures (3-8%), with subcuticular sutures used more often on the trunk and extremities (28%). The most commonly used superficial sutures were nylon (51%) and polypropylene (44%), and the most common absorbable suture was polyglactin 910 (73%). Bilayered closures, undermining, and electrocoagulation were used, on average, in 90% or more sutured repairs. The median diameters (defined as longest extent along any axis) of most final wound defects were 1.1 to 2.0 cm (56%) or 2.1 to 3.0 cm (37%). Fifty-four percent of wounds were repaired by primary closure, 20% with local flaps, and 10% with skin grafting, with the remaining 15% left to heal by second intent (10%) or referred for repair (5%). Experience-related differences were detected in defect size and closure technique: defects less than 2 cm in diameter were seen by less experienced surgeons, and defects greater than 2 cm by more experienced surgeons (Wilcoxon's rank-sum test: p=.02). But more experienced surgeons were less likely to use bilayered closures (r=-0.28, p=.036) and undermining (r=-0.28, p=.035). CONCLUSIONS: There is widespread consensus among cutaneous surgeons regarding optimal suture selection and closure technique by anatomic location. More experienced surgeons tend to repair larger defects but, possibly because of their increased confidence and skill, rely on less complicated repairs.

Dermatology↗
PubMed2006

So you want to be a dermasurgeon: how to get training or choose a fellowship.

BACKGROUND There are many routes to obtaining training in dermasurgery. OBJECTIVE The objective is to discuss some considerations that may guide selection of dermasurgery training. METHODS Current training options are reviewed. RESULTS Some considerations that may guide selection of type of dermasurgery training include: (1) individual temperament; (2) the subtype of dermasurgery in which training is desired (Mohs, cosmetic surgery, laser); (3) family and geographic factors; (4) preference for private practice versus academic career; and (5) proportion of future practice to be devoted to dermasurgery. CONCLUSIONS There are a growing number of training choices for budding dermasurgeons, with multiple options available for each set of particular circumstances.

Career Choice↗
PubMed2005

Surgical repair of temple defects after Mohs micrographic surgery.

BACKGROUND: It is typically recommended that linear surgical closures follow a relaxed skin tension line (RSTL). In the temple, these lines generally run parallel to the orbital rim. However, closures parallel to RSTLs are not feasible for many medium and large surgical defects because of anatomic constraints. OBJECTIVES: We sought to describe our method of repairing temple defects and assess the cosmetic outcome of temple defects repaired perpendicular to the RSTLs. METHODS: We performed a two-phase study of temple closures. In the first phase, a retrospective analysis was performed to assess the defect size and type of closure used for 99 consecutive temple defects. In the second phase, 27 of 86 patients who previously underwent linear surgical repairs in the temple that were designed perpendicular to the RSTLs were evaluated 12 to 24 months postoperatively to assess the cosmetic outcome. Results In the first phase of the study, there was an inverse correlation between the width of the postoperative defect and the ability to close the defect parallel to the RSTLs. The percentage of defects that could be repaired parallel to the RSTLs for defects up to 1 cm in width, 1.1 to 2 cm in width, and greater than 2 cm in width was 46%, 28%, and 8%, respectively. In the second phase of the study, 27 patients with temple defects repaired perpendicular to the RSTLs were evaluated an average of 1.7 years after operation. Most scars (83%) were clinically invisible or barely visible. There were no cases with residual standing cones (dog-ears) or hypertrophic scars. CONCLUSION: The vast majority of temple defects can be repaired in a linear fashion. Smaller defects (width < 1 cm) can be repaired parallel to the RSTL. Those that are larger (width 1-3 cm) or more medially located can be repaired perpendicular to the RSTL, using loose cheek skin for the closure. Very large defects (width > 3-5 cm) or those with limited cheek mobility may require flaps or skin grafts for closure.

Cosmetic Techniques↗
PubMed2005

Efficacy of narrow-margin excision of well-demarcated primary facial basal cell carcinomas.

BACKGROUND: A 4-mm surgical margin of clinically normal skin is the current standard for elliptical excision of basal cell carcinomas (BCCs). However, a 4-mm surgical margin is often not feasible on the face because of cosmetic and functional concerns. As such, facial excisions of BCCs are typically performed with the appropriate margin determined by the surgeon based on clinical features of the tumor. OBJECTIVE: We designed a study to test the efficacy of narrow-margin elliptical excisions for the treatment of small, well-demarcated facial BCCs. METHODS: A total of 134 primary, small (<1 cm), well-demarcated, facial nodular BCCs were excised as an ellipse with 1-, 2-, or 3-mm margins around the visible border of the tumor. The margin used was decided by the dermatologic surgeon based on cosmetic, anatomic, and functional factors, with the goal of clearing the tumor in a single excision. Using the Mohs technique for elliptical specimens, frozen sections were prepared and examined microscopically to provide complete histologic margin control. RESULTS: In all, 134 facial BCCs were included in the study. On average, the tumors measured 0.6 x 0.5 cm. Of these, 27 (20.1%) had positive margins, requiring additional excision. Excisions with 1-, 2-, and 3-mm margins were associated with positive margins in 16%, 24%, and 13% of tumors, respectively. There was no statistically significant difference in the occurrence of positive margins based on tumor size, anatomic location, or the measured margin used. CONCLUSION: Narrow margins (1-3 mm) are inadequate for the excision of small, well-demarcated, primary nodular BCCs of the face. To avoid repetitive operations and the risk of recurrence in anatomically sensitive areas, these tumors should be treated with standard wide margins (eg, 4 mm), or have Mohs micrographic surgery for histologic margin control.

Basal Cell Carcinoma↗
PubMed2005

Clinical appearance of full-thickness skin grafts of the nose.

BACKGROUND: Full-thickness skin grafting (FTSG) is an option for reconstruction of nasal defects. OBJECTIVE: To correlate the clinical outcome of FTSG on the nose with donor site, location of the defect, and defect size. METHODS: Patients with FTSG on the nose following Mohs' micrographic surgery were enrolled. Clinical and photographic assessments were performed. RESULTS: There were 54 FTSGs; the mean age was 20.6 months, and the average size was 2.1 cm2. The clinical assessment score was significantly different across donor sites, with dog-ear skin providing the best results, followed, respectively, by conchal bowl, preauricular, postauricular, and inner arm skin (p = .006). The global clinical outcome determined from the clinical assessment score was good for inner arm skin and excellent for other sites. The photographic assessment score was not different among donor sites (p = .601). There was no correlation of location and size of the defect to the clinical outcome assessed clinically and photographically (p>.05). CONCLUSION: All potential donor sites should be considered to select the donor site that best matches the defect.

Adult↗
PubMed2005

Power and sample size of therapeutic trials in procedural dermatology: how many patients are enough?

BACKGROUND: Many new devices and therapeutic interventions are continually introduced in cutaneous surgery. The efficacy of these new techniques must be compared with that of preexisting standards so that patients can be appropriately counseled. OBJECTIVES: The purpose of this article is to (1) review methods for estimating sample size and power, (2) estimate the range of sample sizes sufficient to ensure that true differences are not missed in clinical trials of new procedural dermatologic therapies, and (3) consider the reasons why the sample size may be too small in procedural dermatology trials and how this problem can be addressed. METHODS: (1) Selective review of textbooks and other relevant literature, presentation of a brief tutorial describing sample size and power determination for therapeutic clinical trials comparing two groups with continuous outcomes variables; (2) implementation of standard formulae and assumptions to estimate sample size in cutaneous surgery therapeutic trials. RESULTS: Assuming that one group receives a standard surgical intervention and another group undergoes a new technique, to identify a moderate difference in efficacy between groups, at least 50 to 200 subjects will need to be enrolled if conventional strategies are used to reduce the likelihood of finding a difference that does not really exist (Type I error), as well as the likelihood of missing a true difference (Type II error). CONCLUSION: By face validity, it is apparent that most efficacy comparisons in procedural dermatology have low sample size and a concomitant risk of failing to detect actual differences between therapeutic arms. Owing to the limitations that restrict surgeons from frequently performing large randomized controlled trials in procedural dermatology, meta-analyses may be needed to pool the results of smaller studies. When it is critically important that differences between groups be accurately identified, dermatologic surgeons may consider eschewing smaller trials in favor of collaborating on larger trials with an adequate sample size.

Dermatology↗
PubMed2005

Subcision for acne scarring: technique and outcomes in 40 patients.

BACKGROUND: Treatment of acne scars is a therapeutic challenge that may require multiple modalities. Subcision is a technique that has been anecdotally reported to be of value in treating so-called "rolling scars." OBJECTIVES: To assess the efficacy of subcision in the treatment of "rolling" acne scars. METHODS: A standard technique was developed for subcision. This was then applied to the treatment of rolling scars in patients, 40 of whom completed treatment and the prescribed follow-up. Six-month follow-up data were obtained from both patients and investigators. RESULTS: Subcision is associated with patient and investigator reports of approximately 50% improvement. Ninety percent of treated patients reported that subcision improved their appearance. The side effects of swelling, bruising, and pain are transient, but patients may have persistent firm bumps at the treatment site. CONCLUSIONS: Subcision appears to be a safe technique that may provide significant long-term improvement in the "rolling scars" of selected patients. When complete resolution of such scars does not occur, combining subcision with other scar revision procedures or repeat subcision may be beneficial.

Acne Vulgaris↗
PubMed2005

Low-level laser therapy for wound healing: mechanism and efficacy.

BACKGROUND: Given the recent interest in light-emitting diode (LED) photomodulation and minimally invasive nonablative laser therapies, it is timely to investigate reports that low-level laser therapy (LLLT) may have utility in wound healing. OBJECTIVES: To critically evaluate reported in vitro models and in vivo animal and human studies and to assess the qualitative and quantitative sufficiency of evidence for the efficacy of LLLT in promoting wound healing. METHOD: Literature review, 1965 to 2003. RESULTS: In examining the effects of LLLT on cell cultures in vitro, some articles report an increase in cell proliferation and collagen production using specific and somewhat arbitrary laser settings with the helium neon (HeNe) and gallium arsenide lasers, but none of the available studies address the mechanism, whether photothermal, photochemical, or photomechanical, whereby LLLT may be exerting its effect. Some studies, especially those using HeNe lasers, report improvements in surgical wound healing in a rodent model; however, these results have not been duplicated in animals such as pigs, which have skin that more closely resembles that of humans. In humans, beneficial effects on superficial wound healing found in small case series have not been replicated in larger studies. CONCLUSION: To better understand the utility of LLLT in cutaneous wound healing, good clinical studies that correlate cellular effects and biologic processes are needed. Future studies should be well-controlled investigations with rational selection of lasers and treatment parameters. In the absence of such studies, the literature does not appear to support widespread use of LLLT in wound healing at this time. Although applications of high-energy (10-100 W) lasers are well established with significant supportive literature and widespread use, conflicting studies in the literature have limited low-level laser therapy (LLLT) use in the United States to investigational use only. Yet LLLT is used clinically in many other areas, including Canada, Europe, and Asia, for the treatment of various neurologic, chiropractic, dental, and dermatologic disorders. To understand this discrepancy, it is useful to review the studies on LLLT that have, to date, precluded Food and Drug Administration approval of many such technologies in the United States. The fundamental question is whether there is sufficient evidence to support the use of LLLT.

Animals↗
PubMed2005

Confidence intervals in procedural dermatology: an intuitive approach to interpreting data.

BACKGROUND: Significant differences observed in therapeutic trials in procedural dermatology are typically denoted by p values of less than .05. Alternatively, significance can be conveyed by use of confidence intervals. OBJECTIVES: The purpose of this article is to clarify how confidence intervals convey the same information about outcomes as p values, albeit in a slightly different manner. METHODS: (1) Selective review of textbooks and other relevant literature and (2) presentation of a brief tutorial describing confidence interval determination for therapeutic clinical trials comparing differences between means of two groups. RESULTS: Routine use of confidence intervals is an intuitively satisfying means for conveying the statistical significance of results and can be used in combination with p values for understanding these results. Specifically, confidence intervals are a useful tool for indicating the size, spread, and direction of the observed differences. Unfortunately, dermatologic surgery trials tend to have low sample sizes, which frequently result in outcomes below the threshold of statistical significance (p > .05, or confidence intervals including 1.00). In the absence of statistical significance, neither p values nor confidence intervals yield definitive results. CONCLUSION: Confidence intervals can complement p values as a means for explaining statistical significant differences. When differences are not statistically significant but are clinically significant and approach statistical significance, neither p values nor confidence intervals can definitively establish whether the observed trends are indicative of an underlying difference. In these cases, common in procedural dermatology, larger, better designed, randomized prospective trials are needed.

Confidence Intervals↗