Placement of an antibiotic oral pack on the hard palate after primary cleft palatoplasty: a randomized controlled trial into the effect on fistula rates.

OBJECTIVE: The objective of this study is to determine whether placement of an antibiotic oral pack on the hard palate reduces fistula rates after primary cleft palatoplasty. SUBJECTS AND METHODS: This study was a parallel blocked randomized controlled trial. The study consisted of two groups of 100 patients each with non-syndromic unilateral complete cleft lip, alveolus, and hard and soft palate that underwent primary palatoplasty. Group A had an oral pack placed on the hard palate for 5 days postoperatively while group B did not. Occurrence of fistulae between both groups was tested using odds ratios (OR). RESULTS: In 2% of the patients in group A, a fistula was found 6 months after palatal surgery. In contrast, in 21% of the patients in group B, a palatal fistula could be confirmed. The fistula occurrence in group A was statistically significantly lower than that in group B (OR = 0.0768, CI = [0.02 … 0.34], p < 0.001). CONCLUSION: The findings of this study provide evidence that the rate of fistula formation after primary palatoplasty is significantly reduced if a pack soaked with antibiotic cream is placed on the palate postoperatively for 5 days. CLINICAL RELEVANCE: The use of an antibiotic pack after cleft palate repair can be recommended to prevent occurrence of oronasal fistulae.

Options for the nasal repair of non-syndromic unilateral Tessier no. 2 and 3 facial clefts.

BACKGROUND: Non-syndromic Tessier no. 2 and 3 facial clefts primarily affect the nasal complex. The anatomy of such clefts is such that the ala of the nose has a cleft. Repairing the ala presents some challenges to the surgeon, especially to correct the shape and missing tissue. Various techniques have been considered to repair these cleft defects. AIM: We present two surgical options to repair such facial clefts. MATERIALS AND METHODS: A nasal dorsum rotational flap was used to treat patients with Tessier no. 2 clefts. This is a local flap that uses tissue from the dorsal surface of the nose. The advantage of this flap design is that it helps move the displaced ala of a Tessier no. 2 cleft into its normal position. A forehead-eyelid-nasal transposition flap design was used to treat patients with Tessier no. 3 clefts. This flap design includes three prongs that are rotated downward. A forehead flap is rotated into the area above the eyelid, the flap from above the eyelid is rotated to infra-orbital area and the flap from the infraorbital area that includes the free nasal ala of the cleft is rotated into place. RESULTS AND CONCLUSIONS: These two flap designs show good results and can be used to augment the treatment options for repairing Tessier no. 2 and 3 facial clefts.

Perceptions of family members of children with cleft lip and palate in hyderabad, India, and its rural outskirts regarding craniofacial anomalies: a pilot study.

Objective : This pilot study aimed to understand cultural perspectives on cleft anomalies in the community of Hyderabad, India, and its rural outskirts. Design : Interviews focusing on perceptions of cleft lip and palate were conducted using a 21-item interview guide approved by the director of the Gosla Srinivas Reddy Institute of Craniofacial Surgery (GSR). Settings : Interviews were conducted at GSR, a specialty surgical center located in Hyderabad, India. Patients and Participants : All patients who presented to GSR with either cleft lip, cleft palate, or cleft lip and palate at the time of this study were included. Results : Of the 23 families interviewed, 12 mothers believed the cleft was caused by an eclipse, and two believed the scientific explanation their physician offered. Fourteen families were offered no explanation for the cleft lip and/or palate at the time of their first physician visit. No families practiced non-Western methods for treatment of the cleft. One family identified beliefs held in the community that their child with a cleft lip was bad luck. Conclusion : A commonly held belief in this community in India is that cleft lip, cleft palate, or cleft lip and palate are caused by an eclipse. Physicians appear to be providing families with insufficient education on cleft impairments. Data generated from studies similar to this can be used to design educational protocols that address this gap in community understanding of orofacial clefting.

Effect of antibiotic pack on hard palate after fistula closure on nasal airflow and reoccurrence rate.

This parallel blocked randomized controlled trial was done in two groups of 30 patients each to determine if placement of an antibiotic oral pack on the hard palate after hard palatal fistula repair reduces nasal air emission and fistula re-occurrence. Group A had an oral pack on the hard palate for 5 days post-operatively while group B did not. In group A, percentage of nasal air emission was tested using nasometry with and without pack. Paired t-tests were performed to compare nasal emissions for patients with and without pack. Recurrence of fistulas after 6 months between group A and B was tested using odds ratio. Effect of nasal air emission on fistula rates was tested using paired t-tests. There was a significant increase (p < 0.0001) in nasal emission after removal of the pack in group A. Fistula re-occurrence tended to be higher in group B (no pack) than group A but this was not significant (p = 0.242). There was no correlation between nasal air emission and fistula rates. In patients with recurrent fistulae, placement of an oral pack after fistula repair diminishes nasal air emission. Whether this has an impact on re-occurrence of fistulae needs to be investigated further.

3D stereophotogrammetric analysis of lip and nasal symmetry after primary cheiloseptoplasty in complete unilateral cleft lip repair.

BACKGROUND: The aim of this study was to evaluate symmetry of the lip and nose in patients with CUCLP after primary cheiloseptoplasty (Afroze technique), in comparison to non-cleft controls. METHODOLOGY: In this prospective study, forty-four patients with operated non-syndromic CUCLP were included. The control group consisted of 44 volunteers without cleft defects of approximately the same age and sex. Primary septoplasty was performed in conjunction with the cleft lip (CL) repair using the Afroze incision. 3D facial images were acquired using 3D stereophotogrammetry. After a 3D cephalometric analysis of the lip and nose was performed in both groups, linear and volumetric data were acquired. Lip and nose symmetry were calculated and compared using Student`s t-tests as well as the Chi square test. RESULTS: For all measurements, the control group was up to 36% closer to perfect symmetry compared to the CUCLP group after primary surgery. This difference was statistically significant. CONCLUSIONS: After primary cheiloseptoplasty according to the Afroze technique in patients with CUCLP, asymmetry in the nose and lip area still exists as compared to non-cleft controls. Although non-cleft individuals also show some degree of asymmetry, the results of this study stress the difficulty in obtaining near normal symmetrical relations.

Developing and standardizing a center to treat cleft and craniofacial anomalies in a developing country like India.

The range of facial deformities is enormous. All produce some degree of disfigurement and result in the impairment of function to some degree, sometimes even to the point of incompatibility with life. Congenital facial defects in India are associated with considerable superstition, social rejection, and failure to integrate into society.In India, cleft defects occur in 1 in 500 births. Congenital facial defects are a pressing problem in India owing to the limited resources to treat such patients. Poverty is a major factor for parents of such children to get appropriate treatment.Setting up an institute to treat children with cleft and craniofacial deformities in India presents problems with financing treatment for poor patients, procuring the right infrastructure, and employing well-trained human resources.The authors have set up such an institute in Hyderabad in the southern state of Andhra Pradesh in India. The logistics of setting up such a facility in a developing country and the future of funding for cleft treatment are important factors to consider while establishing a center for patients with cleft and craniofacial anomalies.The aim of setting up such centers was to provide quality comprehensive treatment for patients from all sections of society with cleft and craniofacial anomalies.

Afroze incision for functional cheiloseptoplasty.

Repair of unilateral cleft lip is a fascinating and challenging procedure. Although a great number of operations have been described for the unilateral cleft lip repair, none fulfill all the plastic surgical criteria, and in most cases, cleft lip repairs require secondary operations in an attempt to achieve described goals of primary cheiloplasty. The Afroze incision is a combination 2 incisions, that is, the Millard incision on the noncleft side and Pfeiffer incision on the cleft side. The flap design is the Millard flap on the noncleft side rotated downward, and the peak of the distal curve of the Pfeiffer flap is positioned in the triangular defect formed by the movement of the Millard flap. The proximal curve lengthens downward to receive the Millard's "C" flap. The advantage of this technique is that there is no tension on the postoperative scar because the incision is essentially horizontal in nature, and the contracture of the scar occurs horizontally rather than vertically. Primary septal repositioning is performed, which provides stability and exact positioning of the previously lifted alar crus of the cleft side and nasal tip, and the nose can grow in a balanced way with equal muscular force being exerted on both sides. This incision can be used in all types of complete unilateral cleft lip regardless of the width of the cleft, shortening the cleft lip segment.

Efficacy of morpho-functional repair in management of different morphological variants of unilateral complete cleft lip.

BACKGROUND: To study the surgical outcome in various morphological variants of unilateral complete cleft lip in our high volume centre over a period of 4 years, using Morpho-Functional technique in all cases by indirect two dimensional photographic analysis. METHODS: In this prospective cohort study, 749 patients with Unilateral Cleft Lip with palate were included over a period of 4 years from January 2010 to December 2014. All Subjects underwent surgery before the age of 1 year with the follow-up two dimensional photographs taken at 4 years post-operatively. Eight measurements were performed on the photographs. All parameters were measured on both Cleft & Non cleft sides and the ratio was considered with the normal side as the base line. Shapiro-Wilk and Kolmogrov-Smirnoff tests were used to confirm that the data was normally distributed. One way ANOVA was done to find out if there were any significant differences amongst the different groups along various parameters, respectively. Further Tukey post hoc analysis was done to confirm where the differences occurred between groups. RESULTS: None of the groups showed any statistical differences on any parameters. There were minor variations between the different groups due to the ranging morphology of the defect but overall satisfactory to good results were seen on all measured parameters evaluated. CONCLUSION: This shows that the Morphofunctional technique, with its combinations & modifications of various school of thought, is versatile enough to achieve good surgical outcomes despite the wide variations seen in size and type of defects in unilateral cleft lip. This comes about because of the comprehensive nature of the technique & the balance that it creates among the affected structures.

Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial.

BACKGROUND: Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate? METHODS: This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C. RESULTS: There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, -0.14 to 2.02). CONCLUSIONS: There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Maxillofacial growth and speech outcome after one-stage or two-stage palatoplasty in unilateral cleft lip and palate. A systematic review.

BACKGROUND: The number of surgical procedures to repair a cleft palate may play a role in the outcome for maxillofacial growth and speech. The aim of this systematic review was to investigate the relationship between the number of surgical procedures performed to repair the cleft palate and maxillofacial growth, speech and fistula formation in non-syndromic patients with unilateral cleft lip and palate. MATERIAL AND METHODS: An electronic search was performed in PubMed/old MEDLINE, the Cochrane Library, EMBASE, Scopus and CINAHL databases for publications between 1960 and December 2015. Publications before 1950-journals of plastic and maxillofacial surgery-were hand searched. Additional hand searches were performed on studies mentioned in the reference lists of relevant articles. Search terms included unilateral, cleft lip and/or palate and palatoplasty. Two reviewers assessed eligibility for inclusion, extracted data, applied quality indicators and graded level of evidence. RESULTS: Twenty-six studies met the inclusion criteria. All were retrospective and non-randomized comparisons of one- and two-stage palatoplasty. The methodological quality of most of the studies was graded moderate to low. The outcomes concerned the comparison of one- and two-stage palatoplasty with respect to growth of the mandible, maxilla and cranial base, and speech and fistula formation. CONCLUSIONS: Due to the lack of high-quality studies there is no conclusive evidence of a relationship between one- or two-stage palatoplasty and facial growth, speech and fistula formation in patients with unilateral cleft lip and palate.

Systematic review of "filling" procedures for lip augmentation regarding types of material, outcomes and complications.

BACKGROUND: The ideal lip augmentation technique provides the longest period of efficacy, lowest complication rate, and best aesthetic results. A myriad of techniques have been described for lip augmentation, but the optimal approach has not yet been established. This systematic review with meta-regression will focus on the various filling procedures for lip augmentation (FPLA), with the goal of determining the optimal approach. METHODS: A systematic search for all English, French, Spanish, German, Italian, Portuguese and Dutch language studies involving FPLA was performed using these databases: Elsevier Science Direct, PubMed, Highwire Press, Springer Standard Collection, SAGE, DOAJ, Sweetswise, Free E-Journals, Ovid Lippincott Williams & Wilkins, Willey Online Library Journals, and Cochrane Plus. The reference section of every study selected through this database search was subsequently examined to identify additional relevant studies. RESULTS: The database search yielded 29 studies. Nine more studies were retrieved from the reference sections of these 29 studies. The level of evidence ratings of these 38 studies were as follows: level Ib, four studies; level IIb, four studies; level IIIb, one study; and level IV, 29 studies. Ten studies were prospective. CONCLUSIONS: This systematic review sought to highlight all the quality data currently available regarding FPLA. Because of the considerable diversity of procedures, no definitive comparisons or conclusions were possible. Additional prospective studies and clinical trials are required to more conclusively determine the most appropriate approach for this procedure. LEVEL OF EVIDENCE: IV.

Assessment of nostril symmetry after primary cleft rhinoplasty in patients with complete unilateral cleft lip and palate.

The aim of this study was to assess the nostril symmetry following primary cleft rhinoplasty done with either a dorsal onlay or columellar strut graft in patients with non-syndromic complete unilateral cleft lip and palate. In this retrospective study 30 consecutive patients treated with autogenous or alloplastic dorsal onlay grafts and 30 consecutive patients treated with autogenous or alloplastic columellar strut grafts for complete unilateral cleft nose reconstruction were analyzed for nasal symmetry. The autogenous grafts used were costo-chondral or septal cartilage and the alloplastic graft used was high density polyethylene (Medpore(®)). Assessment of the nostril symmetry was done using a two-dimensional nasal analysis 24-30 months postoperatively. Ratios between cleft and noncleft side nostril for three parameters were used to assess symmetry namely nostril width, nostril height and nostril gap area. None of the three parameters showed statistically significant changes. A satisfactory, though not statistically significant, difference in symmetrical outcome could be achieved in both the groups with the exception of nostril width symmetry in group treated with dorsal onlay graft.

A comparative study of two different techniques for complete bilateral cleft lip repair using two-dimensional photographic analysis.

BACKGROUND: The aim of this study was to compare the clinical outcomes of two techniques to repair complete bilateral cleft lip by using indirect two-dimensional photographic analysis. METHODS: One hundred eight bilateral cleft patients were included in this study, 54 patients operated on with the Millard technique and 54 patients operated on with the Afroze technique. Each group of patients was further separated into two subgroups containing symmetrical and asymmetrical cleft lips. All patients were photographed preoperatively and 4 years postoperatively in frontal and submentovertical views in a reproducible way. Eight measurements were performed on the photographs. From these measurements, seven ratios were calculated to compare the two techniques. RESULTS: The outcomes of the interobserver and intraobserver measurements were analyzed using the Pearson correlation test. There was a statistically significant reliability in the intraobserver and interobserver ratios. Analysis of the ratios was performed using the independent samples t test (5 percent level of significance). The authors found that the Afroze technique was better than the Millard technique in six of the seven parameters for symmetrical clefts and in four of the seven parameters for asymmetrical clefts; however, there was no statistically significant difference seen between the two techniques. CONCLUSIONS: The Afroze technique seems to have good clinical outcomes on bilateral cleft lip patients, but more research and long-term follow-up are needed to determine the full outcome of the technique in various parameters.

Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair.

BACKGROUND: Cleft lip repair aims to normalize the disturbed anatomy and function. The authors determined whether normalization of blood circulation is achieved. METHODS: The authors measured the microcirculatory flow, oxygen saturation, and hemoglobin level in the lip and nose of controls (n = 22) and in patients with unilateral and bilateral cleft lip-cleft palate. The authors measured these parameters before lip repair (n = 29 and n = 11, respectively), at the end of lip repair (n = 27 and 10, respectively), and in the late postoperative period (n = 33 and n = 20, respectively). The arterial flow velocity was measured in unilateral groups at the same time points (n = 13, n = 11, and n = 12, respectively). Statistical differences were determined using analysis of variance. RESULTS: Before surgery, the arterial flow velocities and microcirculation values were similar on each side of the face and between groups. The microcirculatory flow was significantly higher in the prolabium of bilateral patients than in the philtrum of controls. All circulation values in unilateral and bilateral patients in the late postoperative period were within the range of controls and of those before surgery. Intraoperatively, the authors consistently found a perforating artery on the superficial side of the transverse nasalis muscle. CONCLUSIONS: There appears to be no intrinsic circulatory deficit in unilateral and bilateral cleft lip-cleft palate patients. The increased flow in the prolabium indicates a strong hemodynamic need in this territory, compelling its vascular preservation. Whether surgical preservation of the nasalis perforator artery is of long-term benefit should be addressed in future studies. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Primary septoplasty in the repair of unilateral complete cleft lip and palate.

BACKGROUND: The purpose of this study was to assess and compare nasal symmetry in patients who underwent correction of a complete unilateral cleft lip using the Afroze incision without and with primary septoplasty using a standardized two-dimensional photographic analysis. METHODS: A prospective cohort study of 190 consecutive patients with complete unilateral cleft lip and alveolus with cleft palate treated with or without septoplasty using the Afroze incision technique was conducted at a high-volume center. Eighty-two patients operated on without primary septoplasty and 76 patients operated on with primary septoplasty were evaluated. Nasal symmetry was compared between patients using two-dimensional photographic analysis. Ratios between the cleft side and the non­cleft side for five parameters were used to assess symmetry: alar base­to­interpupillary line distance, columella-to­Cupid's bow distance, nostril gap area, nostril width, and nostril height. The Mann-Whitney U test was used to calculate differences between the two groups. RESULTS: Patients operated on with primary septoplasty showed more nasal symmetry compared with patients operated on without septoplasty. This difference was statistically significant for columella-to­Cupid's bow distance, nostril gap area, and nostril height (p = 0.008, p < 0.001, and p < 0.001, respectively) and for the distance between alar base and the alar base­to­interpupillary line distance (p = 0.145) the difference was present but not statistically significant. For nostril width, no difference was found (p = 0.850). CONCLUSION: Patients treated with primary septoplasty showed better results in terms of nasal symmetry when analyzed using two-dimensional photographic analyses.

Incidence of cleft Lip and palate in the state of Andhra Pradesh, South India.

OBJECTIVE: To assess the incidence of cleft lip and palate defects in the state of Andhra Pradesh, India. DESIGN SETTING: The study was conducted in 2001 in the state of Andhra Pradesh, India. The state has a population of 76 million. Three districts, Cuddapah, Medak and Krishna, were identified for this study owing to their diversity. They were urban, semi-urban and rural, respectively. Literacy rates and consanguinity of the parents was elicited and was compared to national averages to find correlations to cleft births. Type and side of cleft were recorded to compare with other studies around the world and other parts of India. RESULTS: The birth rate of clefts was found to be 1.09 for every 1000 live births. This study found that 65% of the children born with clefts were males. The distribution of the type of cleft showed 33% had CL, 64% had CLP, 2% had CP and 1% had rare craniofacial clefts. Unilateral cleft lips were found in 79% of the patients. Of the unilateral cleft lips 64% were left sided. There was a significant correlation of children with clefts being born to parents who shared a consanguineous relationship and those who were illiterate with the odds ratio between 5.25 and 7.21 for consanguinity and between 1.55 and 5.85 for illiteracy, respectively. CONCLUSION: The birth rate of clefts was found to be comparable with other Asian studies, but lower than found in other studies in Caucasian populations and higher than in African populations. The incidence was found to be similar to other studies done in other parts of India. The distribution over the various types of cleft was comparable to that found in other studies.

Comparison of three incisions to repair complete unilateral cleft lip.

BACKGROUND: The incision design for correcting a unilateral cleft lip is important because all subsequent stages of surgery depend on the access and maneuverability of the incision. This prospective cohort study compares the aesthetic and functional outcomes of three different skin incisions for primary unilateral cleft lip repair. METHODS: Patients with complete unilateral cleft lips (n = 1200) were enrolled and divided into three groups of 400 patients. Each group of patients was operated on with the Millard incision, Pfeifer wave line incision, or Afroze incision. Outcome assessments were performed 2 years postoperatively and consisted of assessment of the white roll, vermilion border, scar, Cupid's bow, lip length, nostril symmetry, and appearance of alar dome and base. RESULTS: With regard to white roll, vermilion border, scar, Cupid's bow, and lip length, the Afroze incision always gave superior results compared with the Millard or Pfeifer incision. Depending on the cut-off for treatment success, the Afroze incision also showed better results regarding nostril symmetry. With respect to the alar base and alar dome, all three incisions showed comparable outcomes. CONCLUSION: The Afroze incision is superior regarding a broad spectrum of outcomes in a heterogeneous population of patients with unilateral cleft lip.

Choice of incision for primary repair of unilateral complete cleft lip: a comparative study of outcomes in 796 patients.

BACKGROUND: No one technique of cleft lip repair consistently produces ideal aesthetic and functional results. This study was carried out in a developing, high-volume center. It compares outcomes attained using two different designs of skin incision used for primary closure of unilateral complete cleft lip and sought to identify the most appropriate technique for clefts of varying morphology. METHODS: Seven hundred ninety-six patients were entered into the study. In each group of slightly less than 400 patients, either a modified Millard or Pfeifer wavy line incision was used, both in conjunction with functional repair of the underlying tissues as described by Delaire. Soft-tissue measurements of the lip and nose were recorded preoperatively. Analysis was based on postoperative assessment of the white roll, vermilion border, scar, Cupid's bow, lip length, and nostril symmetry and appearance of the alar dome and base. RESULTS: Comparison of the two cohorts using Pearson chi-square testing for association and linear trend found a Millard incision gave significantly better results for vermilion match, whereas the Pfeifer method led to a better postoperative lip length. Preconceptions that one particular technique was better suited to certain preoperative cleft anatomical forms were not proven statistically. CONCLUSIONS: Certain preoperative anatomical features may lead the surgeon to choose one particular incision pattern in preference to another, but in this study, it was found that one technique was essentially as good as the other. This suggests that the technique for closure of the underlying tissues is probably of more importance.