Impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants: a systematic review protocol

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1 Impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants: a systematic review protocol Eriko Matsunaka 1,2 Shingo Ueki 2,3 Kiyoko Makimoto 2,3 1. Department of Nursing, Faculty of Nursing, Japanese Red Cross Kyushu International College of Nursing, Fukuoka, Japan 2. Japan Centre for Evidence Based Practice: an Affiliate Center of the Joanna Briggs Institute 3. Department of Health Sciences, Graduate School of Medicine, Osaka University, Osaka, Japan Review question/objective Corresponding author: Eriko Matsunaka e-matsunaka@jrckicn.ac.jp The objective of this systematic review is to examine the impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants. Background Immediately after cleft lip repair in infants, breastfeeding and bottle-feeding are generally restricted. Alternative feeding methods such as spoon-feeding are recommended to avoid placing tension on the surgical wound. 1,2 However, some studies have reported that alternative feeding methods are a source of stress to the infant and cause them to cry incessantly, 3 resulting in postoperative weight loss. 4 This suggests that these alternative feeding methods may have an unfavorable impact on surgical wound healing. However, a consensus on this topic has not been reached. 2,5 The objective of this systematic review is to examine the impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants. Cleft lip and/or palate is a craniofacial anomaly and one of the most common birth defects. The incidence of cleft lip and/or palate differs among races, ethnic groups and geographical areas. The prevalence of cleft lip and/or palate is highest in South American countries (Bolivia: per 10,000 live births; Paraguay: per 10,000 live births), followed by Asian countries (China: per 10,000 live births; Japan: per 10,000 live births). The prevalence is lowest in African countries (3.54 per 10,000 live births). 6 The overall worldwide prevalence is 7.9 per 10,000 births. 6 A cleft lip and/or a cleft palate can occur separately, although they are more likely to occur together early in pregnancy. 2 These anomalies can be surgically repaired. Without proper treatment, patients have aesthetic and functional problems, such as feeding disorders, otitis media and speech difficulties. 7 Patients with cleft lip and/or palate usually undergo a combination of surgical procedures, speech therapy and orthodontic treatment from infancy to young adulthood. 8 Comprehensive treatment is provided with thoughtful consideration of the balance between intervention and growth. 9 Cleft lip repair is carried out first in comprehensive treatment regimens. The aim of cleft lip repair is to create contrast doi: /jbisrir Page 3

2 between the lip and external nose and provide good muscular continuity across the cleft without any scarring. 2 It is usually performed from three to six months of age. 8 Surgery is delayed until this age to allow for growth of the lip structure and assessment of the patient for the presence of comorbidities. 9 The ability of newborn patients with cleft lip and/or palate to drink milk is important for proper growth and development. For cleft lip and/or palate patients in the newborn developmental stage, feeding can be an area of great concern and anxiety for their parents. 10 One study found that 32% of newborn patients with cleft lip and/or palate had poor feeding skills. 11 Feeding difficulties lead to poor growth and development in early infancy 12 and increase the burden of care. 13 Therefore, it is important for new parents to learn appropriate feeding techniques. Infants with cleft lip can generally drink milk from the breast through various ways of feeding. 14 In contrast, infants with both cleft lip and palate have difficulty sucking the nipple because of weak intraoral negative pressure, 11,15 and specially designed nipples are generally used. Although such infants suckle with weakened pressure, these nipples enable them to drink milk by lightly pushing them through their lip. 2 However, after cleft lip repair, infants with cleft lip and/or palate are forced to change their feeding methods (even infants who have managed to drink milk before the repair). Breastfeeding and bottle-feeding are generally restricted immediately after cleft lip repair. Alternative feeding methods such as the use of a spoon, cup or syringe are recommended to avoid placing tension on the surgical incision. The use of a very soft nipple of sufficient size is recommended to provide a dripping milk flow, thus avoiding tension on the operative site. 1 Some authors have recommended that patients with cleft lip and/or palate be spoon-fed for a certain period of time after cleft lip repair to avoid tension on the surgical site. 2 However, management of the surgical site after surgical repair of cleft lip and/or palate varies among countries and healthcare centers. 16,17 Little evidence-based research is available to guide healthcare staff members through the many treatment protocols for cleft lip and/or palate. 18 No consensus about feeding methods after cleft lip repair has been reached. 2,5 The above mentioned alternative feeding methods might influence the process of surgical wound healing. Minimizing crying has been considered to be the most important factor in avoiding tension on the surgical wound. 1 In one study, however, 21.7% of infants who were given milk by a spoon on the first day after cleft lip repair resisted feeding by crying and/or moving the head laterally, while all infants fed by the nipple that had been used preoperatively accepted feeding without a major observable response. 3 In another study, infants who were breastfed or bottle-fed after the repair were reportedly more relaxed than spoon-fed or syringe-fed infants. 19 Changes in feeding methods seem to stress the infants and cause them to cry, which places tension on the wound. These alternative feeding methods may also have other impacts on surgical wound healing. One study reported that infants took longer to drink milk using alternative feeding methods than when using traditional feeding methods after the surgery. 19 A systematic review suggested that alternative feeding methods were associated with less postoperative weight gain in patients than traditional feeding methods. 4 Postoperative nutritional intake also influences wound healing. 20 A long duration of feeding milk coupled with weight loss after the surgery suggests unnecessary energy consumption associated with the alternative feeding methods. Wound healing may consequently be inhibited or delayed. Wound healing complications after surgery include wound infection, dehiscence and proliferative scarring. 21 Surgical wound dehiscence has been regarded as a typical complication after cleft lip and/or palate repair, followed by pyrexia. 22 In one case series, post-surgical complications were found in 11 of 2100 infants who underwent surgical cleft lip and/or palate repair during a seven-year period. 22 Wound doi: /jbisrir Page 4

3 dehiscence results from tissue failure rather than improper suturing technique. 21 Therefore, alternative feeding methods are recommended to avoid placing tension on the surgical wound. However, no strong evidence has been presented to show that breastfeeding or bottle-feeding after cleft lip repair may cause surgical wound dehiscence among infants with cleft lip. 3,5,19,23-25 Our initial search failed to find any systematic review examining the impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair using the Cochrane Library, the JBI Database of Systematic Reviews and Implementation Reports, and other bibliographic databases, including MEDLINE and CINAHL. The proposed systematic review will contribute to the understanding of this topic and identify areas for further research. If breastfeeding or bottle-feeding is recommended immediately after cleft lip repair, the patients will experience less stress and crying, placing less tension on the wound than with alternative feeding methods. Breastfeeding or bottle-feeding will result in more weight gain, facilitating wound healing. Keywords breastfeeding; bottle-feeding; cleft lip; cleft palate; surgical wound dehiscence Inclusion criteria Types of participants This review will consider studies that include infants who have undergone cleft lip repair. The review will exclude studies that include patients who have undergone cleft lip or palate repair over the age of one year. Types of intervention(s) This review will consider studies that evaluate the impact of breastfeeding or bottle-feeding on surgical wound dehiscence after cleft lip repair in infants. Particular focus will be given to studies in which the same feeding method (breastfeeding or bottle-feeding) as that used preoperatively is compared with alternative feeding methods (spoon-, cup-, or syringe-feeding). Types of studies This review will consider any type of experimental study design, including randomized controlled trials (RCT), for feeding interventions after cleft lip repair in infants. If RCTs are not available, other research designs such as quasi-rcts, cohort studies and retrospective studies will be considered for inclusion to enable the identification of current best evidence regarding feeding methods after cleft lip repair. Types of outcomes This review will consider studies that include the following outcome measure: incidence of surgical wound dehiscence as ascertained by health professionals. Secondary outcomes include weight gain, length of postoperative stay and hospital discharge, if enough data is available. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be used in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles doi: /jbisrir Page 5

4 will be searched for additional studies. Studies published and unpublished in in English and Japanese will be considered for inclusion in this review. Studies published from 1950 to 2015 will be considered for inclusion in this review. The reason of this date limit was that the most common technique for cleft lip repair became popular in 1950s. 8,26 The databases to be searched include: PubMed, CINAHL, PsycINFO, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) The search for unpublished studies will include: Mednar Initial keywords to be used will be: cleft lip, cleft palate, breastfeeding, bottle-feeding, feeding methods, harelip, infant nutrition Assessment of methodological quality Titles, abstracts and full texts (if necessary) will be independently reviewed by the primary and secondary reviewers to determine if the studies fit the inclusion criteria of this systematic review. Thereafter, papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data extraction Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. When the required data is not available from the included studies, the authors will be contacted requesting the primary data. Data synthesis Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. We will also consider subgroup meta-analysis such as year of publication and region. Conflicts of interest The authors have no conflicts of interest. doi: /jbisrir Page 6

5 References 1. Johnson HA. The immediate postoperative care of a child with cleft lip: time-proved suggestions. Ann Plast Surg. 1979; 2(5): Peterson-Falzone S, Hardin-Jones M, Karnell M. Cleft Palate Speech, 4th Edition. Elsevier; Assuncao AG, Pinto MA, Peres SP, Tristao MT. Immediate postoperative evaluation of the surgical wound and nutritional evolution after cheiloplasty. Cleft Palate Craniofacial J. 2005; 42(4): Bessell A, Hooper L, Shaw WC, Reilly S, Reid J, Glenny AM. Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate. [Review][Update of Cochrane Database Syst Rev. 2004; (3):CD003315; PMID: ]. Cochrane Database of Syst Rev 2011; (2): CD Skinner J, Arvedson JC, Jones G, Spinner C, Rockwood J. Post-operative feeding strategies for infants with cleft lip. Int J Pediatr Otorhinolaryngol. 1997; 42(2): WHO Registry Meeting on Craniofacial Anomalies. Global registry and database on craniofacial anomalies [Internet]. [cited 2014 Sep 23]. Available from: 7. James R, Edward Ellis, Myron R. Contemporary oral and maxillofacial surgery, 5th edition. Elsevier; Laskin D, Omar Abubaker A. Decision making in oral and maxillofacial surgery. Quintessence publishing company; Miloro M, Ghali G, Larsen P, Waite P. Peterson s principles of oral and maxillofacial surgery, 3rd Edition, Volume 2. People s Medical Publishing House-USA; Kuttenberger J, Ohmer J N, Polska E. Initial counselling for cleft lip and palate: parents' evaluation, needs and expectations. Int J Oral Maxillofac Surg. 2010; 39(3): Reid J, Kilpatrick N, Reilly S. A prospective, longitudinal study of feeding skills in a cohort of babies with cleft conditions. Cleft Palate Craniofac J. 2006; 43(6): Lee J, Nunn J, Wright C. Height and weight achievement in cleft lip and palate. [Republished from Arch Dis Child Oct; 75(4):327-9; PMID: ]. Arch Dis Child. 1997; 76(1): Adams RA, Gordon C, Spangler AA. Maternal stress in caring for children with feeding disabilities: implications for health care providers. J Am Diet Assoc. 1999; 99(8): Reilly S, Reid J, Skeat J, Cahir P, Mei C, Bunik M. ABM clinical protocol #18: guidelines for breastfeeding infants with cleft lip, cleft palate, or cleft lip and palate, revised 2013.[Erratum appears in Breastfeed Med Dec;8(6):519]. Breastfeeding Medicine: Breastfeed Med. 2013; 8(4): Masarei AG, Sell D, Habel A, Mars M, Sommerlad BC, Wade A. The nature of feeding in infants with unrepaired cleft lip and/or palate compared with healthy noncleft infants. Cleft Palate Craniofac J. 2007; 44(3): Agrawal K, Panda K. A modified surgical schedule for primary management of cleft lip and palate in developing countries. Cleft Palate Craniofac J. 2011; 48(1): 1-8. doi: /jbisrir Page 7

6 17. Kochi S. Prevalence of cleft lip/palate and assessment of treatment in Japan - for enhancement of quality of life of cleft patients - J Jpn Cleft Palate Assoc. 2007; 32: Shaw WC, Dahl E, Asher-McDade C, Brattstrom V, Mars M, McWilliam J, et al. A six-center international study of treatment outcome in patients with clefts of the lip and palate: Part 5. General discussion and conclusions. Cleft Palate Craniofac J. 1992; 29(5): Augsornwan D, Surakunprapha P, Pattangtanang P, Pongpagatip S, Jenwitheesuk K, Chowchuen B. Comparison of wound dehiscence and parent's satisfaction between spoon/syringe feeding and breast/bottle feeding in patients with cleft lip repair. J Med Assoc Thai. 2013; 96(Suppl 4): S Langemo D, Anderson J, Hanson D, Hunter S, Thompson P, Posthauer ME. Nutritional considerations in wound care. Adv Skin Wound Care. 2006; 19 (6): 297-8, 300, Miloro M, Ghali G, Larsen P, Waite P. Peterson s principles of oral and Maxillofacial surgery, 3rd Edition, Volume 1. People s Medical Publishing House-USA; Zhang Z, Fang S, Zhang Q, Chen L, Liu Y, Li K, Zhao Y. Analysis of complications in primary cleft lips and palates surgery. J Craniofacial Surg. 2014; 25(3): Darzi MA, Chowdri NA, Bhat AN. Breast feeding or spoon feeding after cleft lip repair: a prospective, randomised study. Br J Plast Surg.1996; 49(1): Cohen M, Marschall MA, Schafer ME. Immediate unrestricted feeding of infants following cleft lip and palate repair. J Craniofacial Surg. 1992; 3(1): Weatherley-White RC, Kuehn DP, Mirrett P, Gilman JI, Weatherley-White CC. Early repair and breast-feeding for infants with cleft lip. Plast Reconstr Surg. 1987; 79(6): Miyazaki T, Matuya A, Shirasuna K, et al. Oral and maxillofacial surgery in Japanese, 2nd Edition. Ishiyaku Publishers, Tokyo, Japan; doi: /jbisrir Page 8

7 Appendix I: Appraisal instruments MAStARI appraisal instrument doi: /jbisrir Page 9

8 doi: /jbisrir Page 10

9 Appendix II: Data extraction instruments MAStARI data extraction instrument doi: /jbisrir Page 11