Faster wound healing with topical negative pressure therapy in difficult-to-heal wounds: a prospective randomized controlled trial.

OBJECTIVE: A randomized clinical trial was conducted to determine the effectiveness and safety of topical negative pressure therapy in patients with difficult-to-heal wounds. METHODS: A total of 24 patients were randomly assigned to either treatment with topical negative pressure therapy or treatment with conventional dressing therapy with sodium hypochlorite. The study end point was 50% reduction in wound volume. The maximum follow-up time was 6 weeks. RESULTS: The median treatment time to 50% reduction of wound volume in the topical negative pressure group was 2.0 weeks (interquartile range = 1) versus 3.5 weeks (interquartile range = 1.5) in the sodium hypochlorite group (P < 0.001). The unadjusted hazard rate ratio for the time until 50% wound volume reduction was 0.123 (P < 0.001). After adjustment for relevant baseline characteristics in a Cox proportional hazards model treatment group, membership was found as the only and statistically significant indicator for the time to 50% wound volume reduction (hazard rate ratio of 0.117 [P < 0.001]). Subgroup analysis of spinal cord injured patients with severe pressure ulcers showed similar statistically significant results as in the total wound group. CONCLUSION: Topical negative pressure resulted in almost 2 times faster wound healing than treatment with sodium hypochlorite, and is safe to use in patients with difficult-to-heal wounds.

Untreated hemangiomas: growth pattern and residual lesions.

BACKGROUND: Hemangiomas of infancy can give rise to alarm because of their rapid growth and occasional dramatic appearance. The objective of this study was to investigate the growth pattern of hemangiomas and risk factors for residual lesions. METHODS: A follow-up study was performed of patients with hemangiomas that were clinically monitored between 1985 and 2000 and who did not receive any treatment. The data were retrieved from medical files. Patients (parents) were asked to complete a questionnaire and invited to our outpatient clinic where the questionnaire was discussed and physical examination was performed. The growth phases of the hemangioma were documented, the timeline of these phases was constructed, and an assessment was made of the residual lesion if present. RESULTS: In 97 patients, 137 hemangiomas were evaluated. A precursor lesion was present in 48 percent of children. Maximum size was reached in 8 months. Involution started at a median age of 2 years and was completed at a median age of 4 years. Residual lesions were present in 69 percent of cases. Superficial nodular hemangiomas showed significantly more residual lesions (74 percent) than the deep hemangiomas (25 percent) (p < 0.001; odds ratio, 8.4; 95 percent confidence interval, 2.4 to 29.1). Untreated infection, ulceration, or bleeding produced a scar in 97 percent of the cases. CONCLUSIONS: Epidermal invasion of the hemangioma is of predictive value for residual lesions. There is no correlation between the growth pattern of a hemangioma and the risk for a residual lesion. This may add to a more detailed prediction of outcome and may help to decide which patient should be treated or not.

Hemangioma in the newborn: increased incidence after chorionic villus sampling.

OBJECTIVES: This study was designed to compare the effects of transcervical chorionic villus sampling (CVS) and amniocentesis on the prevalence of hemangiomas of infancy. METHODS: This is a cohort study of 250 consecutive assessable transabdominal amniocentesis procedures and 250 consecutive assessable transcervical CVS procedures performed between January and September 2002. Parents were asked to fill out a questionnaire regarding the presence of any type of skin lesions. Based on the responses to the questionnaire, children were invited to undergo a physical examination to confirm hemangiomas. RESULTS: Questionnaires were returned in 78% of the CVS group (195/250) and in 72% of the amniocentesis group (180/250). Based on the responses in the questionnaire, 78 children in the CVS group and 42 in the amniocentesis group underwent a physical examination. One or more hemangiomas were present in 53 of 195 (27.2%) children in the CVS group versus 17 of 180 (9.4%) children in the amniocentesis group (odds ratio 3.6, 95% CI: 2.0-6.5). There was no difference in congenital abnormalities between the two groups. CONCLUSION: Transcervical CVS is associated with a significantly increased prevalence of hemangiomas compared with amniocentesis. The clinical features of these hemangiomas do not differ from natural hemangiomas and complications of these hemangiomas are very rare.

A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions.

BACKGROUND: Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process. METHODS: Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed. RESULTS: The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose. CONCLUSIONS: IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.

Torque test measurement in segmental bone defects using porous calcium phosphate cement implants.

This study was performed to assess the bone healing supporting characteristics of porous calcium phosphate (Ca-P) cement when implanted in a rabbit segmental defect model as well as to determine the reliability of torque testing as a method to verify bone healing. The middiaphyseal radius was chosen as the area to create bilaterally increasing defect sizes (5, 10, and 15 mm), which were either filled with porous Ca-P cement or left open as a control. After 12 weeks of implantation, torque test measurements as well as histological and radiographic evaluation were performed. In two of the open 15 mm control defects, bone bridging was visible at the radiographic and histological evaluation. Bone was observed to be present in all porous Ca-P cement implants (5, 10, and 15 mm defects) after 12 weeks. No significant differences in torque measurements were observed between the 5 and 10 mm filled and open control defects using a t-test. In addition, the mechanical strength of all operated specimens was similar compared with nonoperated bone samples. The torsion data for the 15 mm open defect appeared to be lower compared with the filled 15 mm defect, but no significant difference could be proven. Within the limitation of the study design, porous Ca-P cement implants demonstrated osteoconductive properties and confirmed to be a suitable scaffold material in a weight-bearing situation. Further, the used torque testing method was found to be unreliable for testing the mechanical properties of the healed bone defect.

In vivo bone response and mechanical evaluation of electrosprayed CaP nanoparticle coatings using the iliac crest of goats as an implantation model.

Recent trends in clinical implantology include the use of endosseous dental implant surfaces embellished with nano-sized modifications. The current study was initiated to evaluate the mechanical properties, as well as the potential beneficial effects, of electrosprayed CaP nanoparticle-coated (nano-CaP) implants on the in vivo osteogenic response, compared with grit-blasted, acid-etched (GAE) implant surfaces as controls. For this purpose nano-CaP coatings were deposited on cylindrical screw-type (St) implants and implanted bilaterally into the iliac crest of goats for 6weeks. In addition to histological and histomorphometrical analyses, insertion torque and removal torque values were measured on implant placement and retrieval, respectively. The present study showed similar insertion and removal torque values for nano-CaP-coated and GAE control implants, with no statistically significant increase in torque value during the implant period for either group. With regard to bone-implant contact and peri-implant bone volume, no significant differences were found between nano-CaP-coated and GAE implants after 6weeks implantation. In conclusion, this study has demonstrated that in situations in which implants are placed in a non-compromised situation using a standard press fit implantation strategy the performance of electrosprayed nano-CaP coatings is comparable with GAE implants, both with respect to implant fixation and bone healing response.

Anteromedial thigh flaps: an anatomical study to localize and classify anteromedial thigh perforators.

Until now, research on flaps in the anteromedial thigh region has focused on flaps in specific regions. To elucidate the complete pattern of suitable anteromedial thigh perforators, an anatomical study was performed by dissecting nine thighs from different cadavers. The ideal perforator has maximum length and diameter and runs through a septum. According to the data found in our study, these perforators can predominantly be found in the middle third of the anteromedial thigh region. All of the three main thigh vessels supply perforators which can be used for flaps. Pertaining to length and diameter the most suitable perforators originate from the deep femoral artery, which can be found in the proximal and middle third of the anteromedial thigh. Musculocutaneous perforators are found to be longer than septocutaneous perforators. Because of their position, the proximal and distal third perforators should preferentially be used for local pedicled flaps. Defects in the pelvic area and around the knee can be closed with perforator flaps from the proximal and distal anteromedial thigh, respectively. Because of their diameter, length, and number, the middle third perforators should be the first choice for harvesting free flaps. Skin closure is easily achieved in the anteromedial thigh region even when larger flaps are used.

In vivo bioactivity of DNA-based coatings: an experimental study in rats.

DNA-based coatings possess beneficial properties useful for medical and dental implants. The present study evaluated the potential in vivo bioactivity of DNA-based coatings, either or not pretreated in simulated body fluid (SBF). DNA-based coatings were generated on titanium cylinders using layer-by-layer deposition, with bis-ureido-surfactant as the cationic component and DNA as the anionic component. Noncoated titanium implants and CaP-coated implants served as controls. A total of 80 implants, divided in four experimental groups (n = 10) were implanted unilaterally into the lateral femoral condyles of 80 rats. After implantation periods of 1 and 4 weeks, the bone-to-implant contact and bone volume around the implants were determined histomorphometrically. The results of this study showed that DNA-based coatings and CaP coatings increased bone-to-implant contact after 1 week compared to noncoated controls. After 4 weeks of implantation, bone-to-implant contact increased significantly for SBF pretreated DNA coatings and CaP coatings, whereas DNA-coated implants showed no additional effect. The bone-to-implant contact of noncoated controls increased to the level of the DNA-coated implants. Consequently, this study demonstrates that DNA-based coatings are histocompatible and favor early bone responses. SBF-pretreated DNA-based coatings were found to increase both early and late peri-implant bone responses.

The effect of alkaline phosphatase coated onto titanium alloys on bone responses in rats.

The enzyme alkaline phosphatase (ALP) was recently proposed as an implant coating material in order to improve the biological performance of orthopedic and dental implants. The present study evaluated the in vivo bone response to electrosprayed coatings, consisting of ALP, calcium phosphate (CaP) or a combination thereof (composite coating: ALP+CaP) compared to non-coated controls (gritblasted and acid etched). A total of 80 implants (n=10) with a gap of 1.0mm, was implanted intramedullary and bilaterally into the femurs of 80 rats. After 1 and 4 weeks, bone response was evaluated qualitatively (histology) and quantitatively (histomorphometry). The results of this study show that all electrosprayed coatings (ALP, CaP, ALP+CaP) significantly improve osteoconduction compared to non-coated controls after 4 weeks of implantation, without significant differences among these coated groups. Consequently, the results indicate that ALP-coatings improve the osteogenic response to a comparable extent as CaP-coatings or an ALP+CaP composite coating. In conclusion, the current study proofs that ALP-coatings have potential as bone implant coatings, though long-term data remain to be obtained. From a clinical perspective, it was observed that the process of osteoconduction is related to positional determinants, which needs to be taken into account when analyzing data on bone response.

The quantitative assessment of peri-implant bone responses using histomorphometry and micro-computed tomography.

In the present study, the effects of implant design and surface properties on peri-implant bone response were evaluated with both conventional histomorphometry and micro-computed tomography (micro-CT), using two geometrically different dental implants (Screw type, St; Push-in, Pi) either or not surface-modified (non-coated, CaP-coated, or CaP-coated+TGF-beta1). After 12 weeks of implantation in a goat femoral condyle model, peri-implant bone response was evaluated in three different zones (inner: 0-500 microm; middle: 500-1000 microm; and outer: 1000-1500 microm) around the implant. Results indicated superiority of conventional histomorphometry over micro-CT, as the latter is hampered by deficits in the discrimination at the implant/tissue interface. Beyond this interface, both analysis techniques can be regarded as complementary. Histomorphometrical analysis showed an overall higher bone volume around St compared to Pi implants, but no effects of surface modification were observed. St implants showed lowest bone volumes in the outer zone, whereas inner zones were lowest for Pi implants. These results implicate that for Pi implants bone formation started from two different directions (contact- and distance osteogenesis). For St implants it was concluded that undersized implantation technique and loosening of bone fragments compress the zones for contact and distant osteogenesis, thereby improving bone volume at the interface significantly.

Effect of polymer molecular weight on the bone biological activity of biodegradable polymer/calcium phosphate cement composites.

Previous studies demonstrated that the addition of biodegradable polymer microparticles to calcium phosphate (CaP) cement improves the cement's degradative behavior without affecting its handling characteristics, especially its injectability and moldability. We investigated the influence of molecular weight of polymeric microparticles included in CaP cement on implant degradation and bone formation in critical-sized defects. Forty rats received cranial defects filled with formulations of CaP cement and poly(DL-lactic-co-glycolic acid) (PLGA) microparticles. Microparticles consisted of 100% high- (HMW) or low-molecular-weight (LMW) PLGA or mixtures of these (25%, 50%, or 75%). Implantation time was 12 weeks. Porosity measurements showed that the 100% HMW group was significantly less porous than the other groups. Histology and histomorphometry revealed significantly greater implant degradation in the 100% LMW group. Defect bridging was mainly seen in the 75% and 100% LMW groups, with the highest amount of bone in the 100% LMW formulation. These results suggest that LMW PLGA microparticles are associated with better bone formation than HMW PLGA, which is most likely explained by the greater degradation of LMW PLGA microparticles. In conclusion, CaP cement composites with high percentages of LMW PLGA microparticles show good bone transductive behavior, with complete defect bridging. The 100% LMW group turned out to be the best formulation.

Effect of infant orthopedics on facial appearance of toddlers with complete unilateral cleft lip and palate (Dutchcleft).

OBJECTIVE: To evaluate the effect of infant orthopedics (IO) on facial appearance of 54 patients with unilateral cleft lip and palate (UCLP), aged 4 and 6 years. DESIGN: Prospective two-arm randomized controlled clinical trial in three Cleft Palate Centers in the Netherlands (Dutchcleft-trial). INTERVENTIONS: Patients were divided randomly into two groups. Half of the patients (IO+) had a plate until surgical closure of the soft palate at the age of +/- 52 weeks; the other half (IO-) received no intervention. MAIN OUTCOME MEASURES: Facial appearance at 4 and 6 years of age assessed on full face photographs and photographs showing only nose and mouth. Ratings were performed on a VAS-scale by professionals and laymen. RESULTS: At 4 years of age the full face pictures of IO+ children were scored to be more attractive than those of IO- children. However, this difference had disappeared at 6 years of age. At the age of 6, only professionals saw a significant difference on nasolabial photographs between IO+ and IO-. Regression analysis showed a minor effect of occlusion, lip revision, or type of nose reconstruction on the esthetic results. CONCLUSIONS: IO had a positive effect on full facial appearance of UCLP children at the age of 4 years, but at the age of 6, only professionals saw a positive effect of IO on the nasolabial photographs. This is irrelevant for UCLP patients since they deal with laymen in their daily life.

Management of haemangiomas of infancy: a retrospective analysis and a treatment protocol.

Haemangiomas of infancy are common benign endothelial neoplasms that affect roughly 1:10 children. Treatment is indicated in complicated cases. We have evaluated treatment in a multidisciplinary setting. The charts of all affected patients between 1985 and 2000 were reviewed. The personal details, complications, indications for treatment, and outcome, were evaluated. Treatment was started in 77 of the 282 cases reviewed. Ulceration and bleeding were the most common complications and were successfully treated when indicated in 29/39 patients (74%) with wound dressings and antibiotics. Systemic steroids were given to 18 patients, usually for block of the visual fields and respiratory impairment. A good or moderate result was obtained in 16/18 patients. Twelve patients required operation. Based on our results and those of others, we propose a protocol for treatment.

No increased bone formation around alendronate or omeprazole loaded bioactive bone cements in a femoral defect.

Alendronate and omeprazole have been found to influence bone healing by interfering with osteoclastic activity, resulting in increased bone formation. The biological effect of these conventional drugs, incorporated into bioactive bone cement (G2B1), was investigated in a rabbit model. The 2 materials and a control were inserted in defects created in the femoral condyle of rabbits. Implantation time was 6 and 12 weeks. After retrieval, micro-computed tomography and histomorphometry were performed to quantify bone mineral density (BMD) and bone volume (BV) of the implant-surrounding bone mass and the percentage of bone-to-implant contact. BMD and BV were similar in all groups. The percentage of bone-to-implant contact was significantly lower in the alendronate and omeprazole groups than in controls after 6 weeks of implantation. After 12 weeks, this difference in bone contact disappeared for the omeprazole but not for the alendronate implants, which were almost completely surrounded by a fibrous capsule, associated with a limited inflammatory response. In conclusion, in the current study, alendronate and omeprazole did not result in better bone healing when incorporated into bioactive bone cement than did plain control implants. Moreover, an additional cytotoxicity assay revealed that alendronate evoked a toxic response.

The kinetic and biological activity of different loaded rhBMP-2 calcium phosphate cement implants in rats.

The healing of large bone defects can be improved by osteogenic bone graft substitutes, due to growth factor inclusion. A sustained release of these growth factors provides more efficient bioactivity when compared with burst release and might reduce the dose required for bone regeneration, which is desirable for socioeconomical and safety reasons. In this study, we compared different rhBMP-2 loadings in a sustained release system of CaP cement and PLGA-microparticles and were able to couple kinetic to biological activity data. Fifty-two rats received a critical-size cranial defect, which was left open or filled with the cement composites. The implants consisted of plain, high, and five-fold lower dose rhBMP-2 groups. Implantation time was 4 and 12 weeks. Longitudinal in vivo release was monitored by scintigraphic imaging of (131)I-labeled rhBMP-2. Quantitative analysis of the scintigraphic images revealed a sustained release of (131)I-rhBMP-2 for both doses, with different release profiles between the two loadings. However, around 70% of the initial dose was retained in both implant formulations. Although low amounts of rhBMP-2 were released (2.4 +/- 0.8 mug in 5 weeks), histology showed defect bridging in the high-dose implants. Release out of the low-dose implants was not sufficient to enhance bone formation. Implant degradation was limited in all formulations, but was mainly seen in the high-dose group. Low amounts of sustained released rhBMP-2 were sufficient to bridge critically sized defects. A substantial amount of rhBMP-2 was retained in the implants because of the slow release rate and the limited degradation.

Postburn contracture treatment: a healthcare project in Bangladesh.

Over the last 6 years, a health care program aimed at the surgical correction of postburn contractures has taken place in Faridpur, Bangladesh. People in this rural region are very poor and often cannot afford medical treatment. Often secondary flexion contractures of the face and chin as well as the upper and lower extremity impede daily functioning and have an enormous psycho-social impact. The application of basic plastic surgical principles such as local transposition of skin flaps as well as skin grafts restores function dramatically and results in stable skin cover. It is quite challenging - both for the surgeon and the anaesthesiologist - to perform these operations within a rather limited infrastructure. In Bangladesh, there is a monumental need for correction of postburn contractures for the social needs of the patient as well as for functional purposes. Future actions should be directed to the training of surgeons and the development of specialized hospitals to demonstrate social as well as political commitment to health care programs.

Closing capacity of segmental radius defects in rabbits.

In the research of synthetic bone graft substitutes, the relevance for bone regeneration can be confirmed in a critical-sized model. In this study the rabbit radial defect was investigated as an ingenious model of critical size, due to its defect immobilizing intact ulna. In addition, the influence of poly(DL-lactic-co-glycolic acid) (PLGA) on bone regeneration was determined. Sixteen, 4-month-old rabbits received bilateral segmental radial defects of 15 or 20 mm. The osteotomy ends were marked with small titanium pins. Half of the group received injected PLGA microparticle/carboxymethylcellulose implants. Implantation time was 12 weeks. Evaluation consisted of radiographs after surgery and sacrifice, microcomputed tomography and histology. The radiographs revealed that the created defects were significantly smaller after sacrifice. Further a number of radii showed fibrocartilaginous interposition. Both findings indicated instability of the created defect. All evaluation techniques revealed that 15 and 20 mm were not of critical size, as most defects were more or less regenerated. PLGA microparticles did not influence bone regeneration significantly. In conclusion, 15- and 20-mm radius defects in 4-month-old rabbits were not a suitable model for bone regeneration as these defects were neither critical size nor stable. PLGA-microparticle degradation did not influence bone regeneration.

Can face-to-face patient education be replaced by computer-based patient education? A randomised trial.

OBJECTIVE: Computer-based patient education is an effective (therapeutic) tool. More and more studies prove that it can be an effective additive for face-to-face education, but it is still unclear if it is possible to educate patients by only using a computer. Our objective was to compare knowledge levels and satisfaction scores after computer-based patient education versus doctor-based patient education. METHODS: We started a randomised and stratified trial in a large plastic surgery clinic in the Netherlands. One hundred thirteen patients with carpal tunnel syndrome (CTS), scheduled for operation were included. One group received CTS education by a doctor using a checklist (group A). The other group received the same CTS education by specially designed interactive computer program (group B). After 2 weeks, knowledge levels and satisfaction scores were tested by using a questionnaire. RESULTS: One hundred thirteen patients were included, 96 patients finished the questionnaire. With respect to knowledge levels the doctor group (A) scored 20.2 points (max 40 points), and the computer group (B) scored 23.5 points. After correction the difference was 2.8 points (p=0.001). The total satisfaction score in group A was 7.6 and in group B 7.5; a difference of -0.16 (p=0.585). CONCLUSIONS: The results suggest that educating patients can result in a higher knowledge levels by using a computer than by using a doctor. Satisfaction seems equal after both methods of education. PRACTICE IMPLICATIONS: Knowing that you can educate patients without seeing a doctor or nurse seems promising. Patient can be educated by computer-based education programs leaving more time in a consultation for asking questions and discussing treatment options. The discussion will be at a more equal level of knowledge. Possibly it can save time and money resulting in a more efficient patient care, without dissatisfying our patients.

Investigation as to the osteoinductivity of macroporous calcium phosphate cement in goats.

For bone formation in critical-sized or poor healing defects, osteoinductive behavior of synthetic bone grafts is crucial. Although the osteoconductive behavior of calcium phosphate (CaP) cement is generally accepted, its osteoinductive potential is less reported. In this study, osteoinduction of porous CaP cement was investigated. Four goats received each six subcutaneous placed prehardened porous CaP cement implants. Implantation time was 3 and 6 months. After explantation, histological evaluation and scoring with a histological grading scale for soft-tissue implants were performed. The histological sections revealed that the implants degraded for more than 50% over time. The implants had lost their macroporous structure from 3 months on. A medium-thick fibrous capsule with a few inflammatory cells surrounded the implants after 3 months. This capsule significantly decreased in thickness after 6 months. Throughout the implant ingrowth of fibrous tissue was seen with scattered foci of inflammatory cells. Cement particles were surrounded by a layer of inflammatory cells. The massive inflammatory response in the interstice was seen after 3 months, which disappeared after 6 months implantation. No bone formation was detected in any of the specimens. The fast degradation and thereby collapsing of the porous structure of our CaP cement implant might have prevented osteoinduction.

Octyl-2-cyanoacrylate tissue glue (Dermabond) versus Monocryl 6 x 0 Sutures in lip closure.

OBJECTIVE: To assess the value of octyl-2-cyanoacrylate tissue glue in lip closure versus Monocryl stitches. DESIGN: Closure of a cleft lip can be done using transcutaneous Monocryl 6 x 0 sutures or using octyl-2-cyanoacrylate tissue glue (Dermabond). In 15 consecutive patients, the cleft lip was closed with Monocryl 6 x 0 and in another 15 consecutive patients, Dermabond was applied. Outcome parameters were complications, satisfaction of the parents with the cosmetic result, and the cosmetic result as judged by professionals. Satisfaction of the parents was assessed using a questionnaire and a visual analog scale. The cosmetic result as judged by professionals was measured by rating standardized pictures according to a visual analog scale. SETTING: A tertiary referral center for children with craniofacial anomalies. RESULTS: Complications were equal in both patient groups (p = .273). Satisfaction of the parents, as well as the professionals, with the cosmetic result did not show significant differences between the Monocryl 6 x 0 and the Dermabond groups (p = .922 and .983, respectively). However, parents were significantly more positive about the cosmetic result than the professionals were (p = .000). CONCLUSION: The results of lip closure using Dermabond tissue glue equal the cosmetic results of lip closure using transcutaneous Monocryl 6 x 0 sutures.