The Cleft Palate–Craniofacial Journal 52(6) pp. 706–710 November 2015 Ó Copyright 2015 American Cleft Palate–Craniofacial Association
ORIGINAL ARTICLE Early Surgical Complications After Primary Cleft Lip Repair: A Report of 3108 Consecutive Cases ¨ Schonmeyr, ¨ Bjorn M.D., Ph.D., Lisa Wendby, B.A., Alex Campbell, M.D. Objective: To analyze short term surgical complications after primary cleft lip repair. Patients and Design: A total of 3108 consecutive lip repairs with 2062 follow-ups were reviewed retrospectively through medical records. Patients were aged 3 months to 75 years at the time of surgery, with a median of 7 years. Setting: Guwahati Comprehensive Cleft Care Center, Assam, India. Intervention: Primary cleft lip repair. Main Outcome Measures: Documented complications in terms of dehiscence, necrosis, infection, and suture granuloma were compiled. Logistic regression was used with dehiscence (yes/no) or infection (yes/no) as binary dependant variables. Age, cleft type, and surgeon (visiting/long term) were used as covariates. Results: Among the 2062 patients who returned for early follow-up, 90 (4.4%) had one or more complications. Dehiscence (3.2%) and infection (1.1%) were the most common types of complication. Visiting surgeon, complete cleft, and bilateral cleft were significantly associated with wound dehiscence, and complete cleft was associated with wound infection according to the logistic regression analysis. Of patients with bilateral complete clefts, 6.9% suffered from some degree of wound dehiscence. Conclusion: In a setting where presurgical molding is unavailable and patients present at all ages, lip wound dehiscence is a relatively common complication in patients with bilateral complete clefts. The risk of dehiscence, however, is reduced when these cases are assigned to surgeons with experience with these types of clefts. We also found that the incidence of wound infection can be kept relatively low, even without the use of postoperative antibiotics. KEY WORDS:
dehiscense, developing world, infection, late cleft lip repair, lipplasty
Cleft lip repair is a common surgical procedure all over the world. However, conflicting data regarding the incidence and definition of surgical complications following lip repair can be found in the literature. Complication rates range from 1.7% to 8.2%, and definitions include dehiscence, infection, stitch granuloma, hypertrophic scarring, and notching (Wilhelmsen and Musgrave, 1966; Bromley et al., 1983; WeatherleyWhite et al., 1987; Lees and Pigott, 1992; Eaton et al., 1994; Al-Thunyan et al., 2009; Aziz et al., 2009; Nagy and Mommaerts, 2011; Halli et al., 2012; Abdurrazaq et
al., 2013). Some report higher complication rates, but no distinction is then made of cleft lip and palate cases (Schettler, 1973; Orkar et al., 2002; Jones et al., 2010). Moreover, in the existing studies, series are often small and follow-up rates are not always accounted for, making the combined results inconsistent and inconclusive. Most previous studies have only included around a hundred patients or fewer (Bromley et al., 1983; Weatherley-White et al., 1987; Lees and Pigott, 1992; Orkar et al., 2002; Al-Thunyan et al., 2009; Aziz et al., 2009; Jones et al., 2010; Halli et al., 2012; Abdurrazaq et al., 2013), but nonetheless, a few larger series have been published. Wilhelmsen and Musgrave (1966) presented a series of 565 patients with a 4.6% incidence of suture line breakdown. However, their study was based on surgeries performed from 1950 to 1964, and given that surgical protocols and materials have evolved over the years, a more current report would be of interest. Schettler (1973) presented a study of 1565 cleft surgeries in 1973, but unfortunately, no distinction was made of cleft lip and palate cases. More recently, Nagy and Mommaerts (2011) reported a 2.6% incidence of wound infection and/or dehiscence in a series of 302 cases. At their center in Bruges, Belgium,
Dr. Schonmeyr is International Staff Surgeon, Guwahati Com¨ prehensive Cleft Care Center, Mahendra Mohan Choudhury Hospital Panbazar, Guwahati, India, and Resident Plastic Surgeon, Department of Plastic and Reconstructive Surgery, Skane University Hospital, Malmo, Sweden. Ms. Wendby is Research Coordinator, Guwahati Comprehensive Cleft Care Center, Mahendra Mohan Choudhury Hospital Panbazar, Guwahati, India. Dr. Campbell is Plastic Surgeon, Operation Smile, Virginia Beach, Virginia. Submitted May 2014; Revised July 2014; Accepted July 2014. Address correspondence to: Dr. Bjorn Skane University ¨ Schonmeyr, ¨ Hospital, Department of Plastic Surgery, Jan Waldenstroms gata 18, ¨ 20502 Malmo, ¨ Sweden. E-mail [email protected]. DOI: 10.1597/14-158 706
Schonmeyr et al., EARLY COMPLICATIONS AFTER CLEFT LIP REPAIR ¨
TABLE 1
Background of 3108 Primary Cleft Lip Repairs Mean ¼ 11.9 y Median ¼ 7 y Range, 3 mo–75 y Male: 1825 (58.7%) Female: 1283 (41.3%) UCL incomplete: 1434 (46.1%) UCL complete: 1248 (40.2%) BCL incomplete: 138 (4.4%) BCL complete: 288 (9.3%)† Long term: 2360 (75.9)‡ Visiting: 746 (24.0%) Missing: 2 (0.1%)
Age
Sex Diagnosis*
Surgeon
* UCL ¼ unilateral cleft lip; BCL ¼ bilateral cleft lip. † Complete on one or two sides. ‡ 6 months of service or more.
patients follow an extensive postoperative wound care protocol including a Logan’s bow, arm restraints, postoperative antibiotics, specific wound ointment, and dressings as well as a wound cleaning protocol after feeding. Therefore, the results from Bruges might not be applicable in a wider perspective. Most cleft surgeries are performed in less developed regions of the world, where resources are limited, hygiene standards are lower, and patient compliance and follow-ups are less predictable (World Health Organization, 2000). In this study we report of the surgical complications in 3108 consecutive primary cleft lip repairs performed at the Guwahati Comprehensive Cleft Care Center in Assam, India. This is, to our knowledge, the largest study of its kind and could serve as a benchmark in terms of incidence of lip complications in this setting. PATIENTS
AND
METHODS
Retrospective data was collected from medical records. A total of 3108 consecutive patients underwent primary cleft lip repair at Guwahati Comprehensive Cleft Care Center in Assam, India, between February 2011 and October 2013. Background data of the patients are listed in Table 1. Malnourished patients were enrolled in a nutrition program and were not operated upon until they were considered fit for surgery. The majority of the patients with unilateral cleft lip were operated upon with a rotation advancement technique (Mohler), and in general, a Millard-type repair was used for those with bilateral cleft lip. Surgeons were labeled as either visitors or long-term staff (.6 months of service at the center). The visitors consisted of surgeons with limited or extensive experience with cleft surgery. The patients typically received a single intraoperative dose of cefuroxime (30 mg/kg). After surgery, patients and their families were involved in an education program for postoperative care. The wound care protocol included gently washing the wound area with soap and water two to three times daily. Patients were
TABLE 2
707
Complications Based on 2062 Follow-Ups
Type of Complication
Incidence, n (%)
Dehiscence Infection Dehiscence and infection Stitch granuloma Philtral flap necrosis and dehiscence Other (pressure necrosis)
61 17 5 5 1 1
(3.0) (0.8) (0.2) (0.2) (0.05) (0.05)
advised to resume a regular diet immediately, with breast-feeding for infants, and instructions were given for oral hygiene including brushing teeth twice a day. No arm restraints were used. Patients were discharged the day after surgery with postoperative instructions written in Assamese (the predominant local language), including pictographs for illiterate patients. Of the 3108 patients, 2062 (66.3%) returned for followup within 4 weeks. At the time of follow-up the patients were examined by a cleft surgeon, and complications in terms of dehiscence, necrosis, infection, and suture granuloma were recorded in a standardized manner. Dehiscence was defined as any disruption in the suture line in the vermillion or in the skin of the lip, columella, or nasal sill. Statistics Statistical analyses were preformed using IBM SPSS version 21 for Windows (SPSS Inc., Chicago, IL). Logistic regression was used with dehiscence (with or without infection) or infection (with or without dehiscence) as binary dependent variables in two separate models. Age, visiting surgeon versus long-term surgeon (.6 months of service), incomplete versus complete clefts, and unilateral versus bilateral clefts were used in each model as covariates. The Hosmer-Lemeshow goodness-of-fit test was used to confirm the reliability of the model. P values less than .05 were considered statistical significant. Ethics This study was reviewed and approved by Operation Smile India Institutional Ethics Committee. RESULTS Among the 2062 patients who returned for early follow-up, 90 (4.4%) had one or more complications (Table 2). The majority of the complications consisted of wound dehiscence (3.2%) and/or wound infection (1.1%). In the majority of the patients with wound dehiscence, the complication involved less than 25% of the skin/vermillion (Table 3). Ten complications (0.5%)
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Cleft Palate–Craniofacial Journal, November 2015, Vol. 52 No. 6
TABLE 3
Degree of Dehiscence
Degree of Dehischence 25% 26%–74% 75% Missing value
Incidence, n (%) 42 13 11 1
(62.7) (19.4) (16.4) (1.5)
were severe enough for the patients to be scheduled for revision surgery. The logistic regression analysis showed that the incidence of dehiscence (with or without infection) was significantly associated with visiting surgeons (P , .001, odds ratio [OR] ¼ 2.64, 95% CI, 1.61 to 4.33), complete clefts (P , .05, OR ¼ 1.830, 95% CI, 1.07 to 3.11), and bilateral clefts (P , .05, OR ¼ 2.01, 95% CI, 1.14 to 3.57). The incidence of dehiscence according to surgeon and cleft type can be seen in Figure 1.
FIGURE 2 Incidence of wound infection after primary lip repair, comparing complete and incomplete clefts.
We also found that wound infection (with or without dehiscence) was significantly associated with complete clefts (P , .05, OR ¼ 3.34, 95% CI, 1.23 to 9.10). The incidence of wound infection depending on complete or incomplete clefts can be seen in Figure 2. The age of the patient was not found to be associated with dehiscence or infection in a statistically significant manner. DISCUSSION
FIGURE 1 Incidence of wound dehiscence after primary lip repair, depending on A: surgeon (visiting or permanent) and B: cleft type.
In our study, based on 2062 patients with follow-ups, we found an overall complication rate of 4.4%, consisting mainly of skin dehiscence (3.2%) and wound infection (1.1%). This rate compares well with Wilhelmsen and Musgrave’s study from 1966. They reported a 4.6% incidence of minor or major suture line breakdown. No distinction, however, was made between wound infection and dehiscence. Wound infection can lead to wound dehiscence and vice versa, but our study suggests that these two complications represent different entities. Among the 83 patients who suffered from infection and/or dehiscence in our series, only five patients presented with both these complications. Furthermore, our logistic regression analysis suggests that wound infection and dehiscence have different etiologies. We found a statistically significant relationship between lip dehiscence and visiting surgeon, complete cleft, and bilateral cleft. High dehiscence rates among visiting surgeons could perhaps be due to the different preconditions compared with a familiar working environment back home. The cleft panorama and the patient clientele in a less developed environment can differ greatly from a Western setting where patients are treated with presurgical molding and are operated upon at standardized ages. As a
Schonmeyr et al., EARLY COMPLICATIONS AFTER CLEFT LIP REPAIR ¨
consequence, the clefts may be wider and less aligned than one is used to, which may require adjustments of one’s standard surgical technique or wound closure under greater tension. The association between dehiscence and complete and bilateral clefts is not surprising and supports the assumption that excessive skin tension can cause dehiscence. In line with this, the bilateral complete clefts were distinctly overrepresented among the cases of dehiscence. Bromley et al. (1983) made a similar observation, where 5 (16%) of 31 patients with bilateral cleft lip suffered from dehiscence. We believe that extra precautions should be considered when treating patients with bilateral complete lip, and our regression analysis suggests that experienced surgeons should be assigned to these patients. Part of the permanent staff at our center uses a de-epithelialized strip of flanking dermis on both sides of the philtral flap, according to Mulliken (2001), to strengthen the suture line and prevent dehiscence. Presurgical molding, lip adhesion, or staged lip repair could also be considered, but for many patients in the less developed part of the world this is not a realistic option. Whether the setting is a mission or a center, many patients will have the opportunity to receive treatment only a limited number of times due to accessibility, loss of income, and so forth (Schwarz and Bhai Khadka, 2004; Adeyemo et al., 2009). According to our logistic regression analysis, wound infections were associated with complete clefts. An explanation for this could be that complete clefts need more extensive surgery, and the surgery involves the nose and oral cavity to a greater extent. Our findings are in support of Schettler (1973), who found a 13.3% infection rate if surgery was more than 2 hours compared with 5.1% if surgery time was less than 2 hours. Even though Schettler (1973) did not differentiate between lip and palate surgeries, our infection rate of 1.1% can be regarded as relatively low. Nagy and Mommaerts (2011) reported 8 patients (2.6%) of 302 primary cleft lip repairs with dehiscence and/or infection. The article did not distinguish between the two types of complications, but it was stated that five patients (1.6%) were treated with additional oral antibiotics, indicating an infectious component in these cases. Nagy’s postoperative wound care protocol included arm restraints, wound ointment, and dressings as well as postoperative intravenous and oral antibiotics. The use of these routines to decrease wound infections can perhaps be questioned, considering that our center seems to have a comparable incidence of wound infections without using any of these preventive measures. We do, however, feel that our patient education program, including basic instructions for post–op wound care, has brought our infection rates down. We have previously compared cleft missions, with or without this program, and found that infection
709
rates were reduced from 3.7% to 0.4% (Schonmeyr et ¨ al., 2014). CONCLUSION In our series of 3108 primary lip repairs, we found a complication rate of 4.4% based on 2062 follow-ups. The most common complication was skin dehiscence, and this complication was significantly overrepresented among patients who had bilateral complete clefts. We therefore advise that extra precautions should be considered when operating upon bilateral complete clefts in this setting. Furthermore, these patients should be assigned to surgeons with experience with this type of clefts. We also found a low incidence of wound infection among our patients without the routine use of oral or local antibiotics postoperatively. Instead, we recommend educating patients in simple routines of hygiene and wound care before discharge. Acknowledgments. This study was carried out at the Guwahati Comprehensive Cleft Care Center (Assam, India), located at the Mahendra Mohan Choudhury Hospital, Guwahati. The authors acknowledge the support of Government of Assam, the National Rural Health Mission, the Sir Dorabji Tata Trust and Allied Trusts, Operation Smile International, and Operation Smile India for providing infrastructure and funding to ensure that all patients at this center are treated free of cost with no commercial or financial gains to any member of the team.
REFERENCES Abdurrazaq TO, Micheal AO, Lanre AW, Olugbenga OM, Akin LL. Surgical outcome and complications following cleft lip and palate repair in a teaching hospital in Nigeria. Afr J Paediatr Surg. 2013;10:345–357. Adeyemo WL, Ogunlewe MO, Desalu I, Ladeinde AL, Mofikoya BO, Adeyemi MO, Adepoju AA, Hassan OO. Cleft deformities in adults and children aged over six years in Nigeria: reasons for late presentation and management challenges. Clin Cosmet Investig Dent. 2009;1:63–69. Al-Thunyan AM, Aldekhayel SA, Al-Meshal O, Al-Qattan MM. Ambulatory cleft lip repair. Plast Reconstr Surg. 2009;124:2048– 2053. Aziz SR, Rhee ST, Redai I. Cleft surgery in rural Bangladesh: reflections and experiences. J Oral Maxillofac Surg. 2009;67:1581– 1588. Bromley GS, Rothaus KO, Goulian D Jr. Cleft lip: morbidity and mortality in early repair. Ann Plast Surg. 1983;10:214–217. Eaton AC, Marsh JL, Pilgram TK. Does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg. 1994;94:911–918. Halli R, Joshi A, Kini Y, Kharkar V, Hebbale M. Retrospective analysis of sutureless skin closure in cleft lip repair. J Craniofac Surg. 2012;23:40–44. Jones JL, Canady JW, Brookes JT, Wehby GL, L’Heureux J, Schutte BC, Murray JC, Dunnwald M. Wound complications after cleft repair in children with Van der Woude syndrome. J Craniofac Surg. 2010;21:1350–1353. Lees VC, Pigott RW. Early postoperative complications in primary cleft lip and palate surgery—how soon may we discharge patients from hospital? Br J Plast Surg. 1992;45:232–234.
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Mulliken JB. Primary repair of bilateral cleft lip and nasal deformity. Plast Reconstr Surg. 2001;108:181–194. Nagy K, Mommaerts MY. Postoperative wound management after cleft lip surgery. Cleft Palate Craniofac J. 2011;48:584–586. Orkar KS, Ugwu BT, Momoh JT. Cleft lip and palate: the Jos experience. East Afr Med J. 2002;79:510–513. Schettler D. Intra- and postoperative complications in surgical repair of clefts in infancy. J Maxillofac Surg. 1972;1:40–44. Schonmeyr B, Restrepo C, Wendby L, Gillenwater J, Campbell A. ¨ Lessons learned from two consecutive cleft lip and palate missions and the impact of patient education. J Craniofac Surg. 2014;25:1610–1613.
Schwarz R, Bhai Khadka S. Reasons for late presentation of cleft deformity in Nepal. Cleft Palate Craniofac J. 2004;41:199–201. Weatherley-White RC, Kuehn DP, Mirrett P, Gilman JI, WeatherleyWhite CC. Early repair and breast-feeding for infants with cleft lip. Plast Reconstr Surg. 1987;79:879–887. Wilhelmsen HR, Musgrave RH. Complications of cleft lip surgery. Cleft Palate J. 1966;3:223–231. World Health Organization. Global strategies to reduce healthcare burden of craniofacial anomalies: report of WHO meetings on international collaborative research on craniofacial anomalies. Geneva, Switzerland. 2000. Available at http://www.who.int/ genomics/anomalies/cfaproject/en/. Accessed June 28, 2014.
ORIGINAL ARTICLE Early Surgical Complications After Primary Cleft Lip Repair: A Report of 3108 Consecutive Cases ¨ Schonmeyr, ¨ Bjorn M.D., Ph.D., Lisa Wendby, B.A., Alex Campbell, M.D. Objective: To analyze short term surgical complications after primary cleft lip repair. Patients and Design: A total of 3108 consecutive lip repairs with 2062 follow-ups were reviewed retrospectively through medical records. Patients were aged 3 months to 75 years at the time of surgery, with a median of 7 years. Setting: Guwahati Comprehensive Cleft Care Center, Assam, India. Intervention: Primary cleft lip repair. Main Outcome Measures: Documented complications in terms of dehiscence, necrosis, infection, and suture granuloma were compiled. Logistic regression was used with dehiscence (yes/no) or infection (yes/no) as binary dependant variables. Age, cleft type, and surgeon (visiting/long term) were used as covariates. Results: Among the 2062 patients who returned for early follow-up, 90 (4.4%) had one or more complications. Dehiscence (3.2%) and infection (1.1%) were the most common types of complication. Visiting surgeon, complete cleft, and bilateral cleft were significantly associated with wound dehiscence, and complete cleft was associated with wound infection according to the logistic regression analysis. Of patients with bilateral complete clefts, 6.9% suffered from some degree of wound dehiscence. Conclusion: In a setting where presurgical molding is unavailable and patients present at all ages, lip wound dehiscence is a relatively common complication in patients with bilateral complete clefts. The risk of dehiscence, however, is reduced when these cases are assigned to surgeons with experience with these types of clefts. We also found that the incidence of wound infection can be kept relatively low, even without the use of postoperative antibiotics. KEY WORDS:
dehiscense, developing world, infection, late cleft lip repair, lipplasty
Cleft lip repair is a common surgical procedure all over the world. However, conflicting data regarding the incidence and definition of surgical complications following lip repair can be found in the literature. Complication rates range from 1.7% to 8.2%, and definitions include dehiscence, infection, stitch granuloma, hypertrophic scarring, and notching (Wilhelmsen and Musgrave, 1966; Bromley et al., 1983; WeatherleyWhite et al., 1987; Lees and Pigott, 1992; Eaton et al., 1994; Al-Thunyan et al., 2009; Aziz et al., 2009; Nagy and Mommaerts, 2011; Halli et al., 2012; Abdurrazaq et
al., 2013). Some report higher complication rates, but no distinction is then made of cleft lip and palate cases (Schettler, 1973; Orkar et al., 2002; Jones et al., 2010). Moreover, in the existing studies, series are often small and follow-up rates are not always accounted for, making the combined results inconsistent and inconclusive. Most previous studies have only included around a hundred patients or fewer (Bromley et al., 1983; Weatherley-White et al., 1987; Lees and Pigott, 1992; Orkar et al., 2002; Al-Thunyan et al., 2009; Aziz et al., 2009; Jones et al., 2010; Halli et al., 2012; Abdurrazaq et al., 2013), but nonetheless, a few larger series have been published. Wilhelmsen and Musgrave (1966) presented a series of 565 patients with a 4.6% incidence of suture line breakdown. However, their study was based on surgeries performed from 1950 to 1964, and given that surgical protocols and materials have evolved over the years, a more current report would be of interest. Schettler (1973) presented a study of 1565 cleft surgeries in 1973, but unfortunately, no distinction was made of cleft lip and palate cases. More recently, Nagy and Mommaerts (2011) reported a 2.6% incidence of wound infection and/or dehiscence in a series of 302 cases. At their center in Bruges, Belgium,
Dr. Schonmeyr is International Staff Surgeon, Guwahati Com¨ prehensive Cleft Care Center, Mahendra Mohan Choudhury Hospital Panbazar, Guwahati, India, and Resident Plastic Surgeon, Department of Plastic and Reconstructive Surgery, Skane University Hospital, Malmo, Sweden. Ms. Wendby is Research Coordinator, Guwahati Comprehensive Cleft Care Center, Mahendra Mohan Choudhury Hospital Panbazar, Guwahati, India. Dr. Campbell is Plastic Surgeon, Operation Smile, Virginia Beach, Virginia. Submitted May 2014; Revised July 2014; Accepted July 2014. Address correspondence to: Dr. Bjorn Skane University ¨ Schonmeyr, ¨ Hospital, Department of Plastic Surgery, Jan Waldenstroms gata 18, ¨ 20502 Malmo, ¨ Sweden. E-mail [email protected]. DOI: 10.1597/14-158 706
Schonmeyr et al., EARLY COMPLICATIONS AFTER CLEFT LIP REPAIR ¨
TABLE 1
Background of 3108 Primary Cleft Lip Repairs Mean ¼ 11.9 y Median ¼ 7 y Range, 3 mo–75 y Male: 1825 (58.7%) Female: 1283 (41.3%) UCL incomplete: 1434 (46.1%) UCL complete: 1248 (40.2%) BCL incomplete: 138 (4.4%) BCL complete: 288 (9.3%)† Long term: 2360 (75.9)‡ Visiting: 746 (24.0%) Missing: 2 (0.1%)
Age
Sex Diagnosis*
Surgeon
* UCL ¼ unilateral cleft lip; BCL ¼ bilateral cleft lip. † Complete on one or two sides. ‡ 6 months of service or more.
patients follow an extensive postoperative wound care protocol including a Logan’s bow, arm restraints, postoperative antibiotics, specific wound ointment, and dressings as well as a wound cleaning protocol after feeding. Therefore, the results from Bruges might not be applicable in a wider perspective. Most cleft surgeries are performed in less developed regions of the world, where resources are limited, hygiene standards are lower, and patient compliance and follow-ups are less predictable (World Health Organization, 2000). In this study we report of the surgical complications in 3108 consecutive primary cleft lip repairs performed at the Guwahati Comprehensive Cleft Care Center in Assam, India. This is, to our knowledge, the largest study of its kind and could serve as a benchmark in terms of incidence of lip complications in this setting. PATIENTS
AND
METHODS
Retrospective data was collected from medical records. A total of 3108 consecutive patients underwent primary cleft lip repair at Guwahati Comprehensive Cleft Care Center in Assam, India, between February 2011 and October 2013. Background data of the patients are listed in Table 1. Malnourished patients were enrolled in a nutrition program and were not operated upon until they were considered fit for surgery. The majority of the patients with unilateral cleft lip were operated upon with a rotation advancement technique (Mohler), and in general, a Millard-type repair was used for those with bilateral cleft lip. Surgeons were labeled as either visitors or long-term staff (.6 months of service at the center). The visitors consisted of surgeons with limited or extensive experience with cleft surgery. The patients typically received a single intraoperative dose of cefuroxime (30 mg/kg). After surgery, patients and their families were involved in an education program for postoperative care. The wound care protocol included gently washing the wound area with soap and water two to three times daily. Patients were
TABLE 2
707
Complications Based on 2062 Follow-Ups
Type of Complication
Incidence, n (%)
Dehiscence Infection Dehiscence and infection Stitch granuloma Philtral flap necrosis and dehiscence Other (pressure necrosis)
61 17 5 5 1 1
(3.0) (0.8) (0.2) (0.2) (0.05) (0.05)
advised to resume a regular diet immediately, with breast-feeding for infants, and instructions were given for oral hygiene including brushing teeth twice a day. No arm restraints were used. Patients were discharged the day after surgery with postoperative instructions written in Assamese (the predominant local language), including pictographs for illiterate patients. Of the 3108 patients, 2062 (66.3%) returned for followup within 4 weeks. At the time of follow-up the patients were examined by a cleft surgeon, and complications in terms of dehiscence, necrosis, infection, and suture granuloma were recorded in a standardized manner. Dehiscence was defined as any disruption in the suture line in the vermillion or in the skin of the lip, columella, or nasal sill. Statistics Statistical analyses were preformed using IBM SPSS version 21 for Windows (SPSS Inc., Chicago, IL). Logistic regression was used with dehiscence (with or without infection) or infection (with or without dehiscence) as binary dependent variables in two separate models. Age, visiting surgeon versus long-term surgeon (.6 months of service), incomplete versus complete clefts, and unilateral versus bilateral clefts were used in each model as covariates. The Hosmer-Lemeshow goodness-of-fit test was used to confirm the reliability of the model. P values less than .05 were considered statistical significant. Ethics This study was reviewed and approved by Operation Smile India Institutional Ethics Committee. RESULTS Among the 2062 patients who returned for early follow-up, 90 (4.4%) had one or more complications (Table 2). The majority of the complications consisted of wound dehiscence (3.2%) and/or wound infection (1.1%). In the majority of the patients with wound dehiscence, the complication involved less than 25% of the skin/vermillion (Table 3). Ten complications (0.5%)
708
Cleft Palate–Craniofacial Journal, November 2015, Vol. 52 No. 6
TABLE 3
Degree of Dehiscence
Degree of Dehischence 25% 26%–74% 75% Missing value
Incidence, n (%) 42 13 11 1
(62.7) (19.4) (16.4) (1.5)
were severe enough for the patients to be scheduled for revision surgery. The logistic regression analysis showed that the incidence of dehiscence (with or without infection) was significantly associated with visiting surgeons (P , .001, odds ratio [OR] ¼ 2.64, 95% CI, 1.61 to 4.33), complete clefts (P , .05, OR ¼ 1.830, 95% CI, 1.07 to 3.11), and bilateral clefts (P , .05, OR ¼ 2.01, 95% CI, 1.14 to 3.57). The incidence of dehiscence according to surgeon and cleft type can be seen in Figure 1.
FIGURE 2 Incidence of wound infection after primary lip repair, comparing complete and incomplete clefts.
We also found that wound infection (with or without dehiscence) was significantly associated with complete clefts (P , .05, OR ¼ 3.34, 95% CI, 1.23 to 9.10). The incidence of wound infection depending on complete or incomplete clefts can be seen in Figure 2. The age of the patient was not found to be associated with dehiscence or infection in a statistically significant manner. DISCUSSION
FIGURE 1 Incidence of wound dehiscence after primary lip repair, depending on A: surgeon (visiting or permanent) and B: cleft type.
In our study, based on 2062 patients with follow-ups, we found an overall complication rate of 4.4%, consisting mainly of skin dehiscence (3.2%) and wound infection (1.1%). This rate compares well with Wilhelmsen and Musgrave’s study from 1966. They reported a 4.6% incidence of minor or major suture line breakdown. No distinction, however, was made between wound infection and dehiscence. Wound infection can lead to wound dehiscence and vice versa, but our study suggests that these two complications represent different entities. Among the 83 patients who suffered from infection and/or dehiscence in our series, only five patients presented with both these complications. Furthermore, our logistic regression analysis suggests that wound infection and dehiscence have different etiologies. We found a statistically significant relationship between lip dehiscence and visiting surgeon, complete cleft, and bilateral cleft. High dehiscence rates among visiting surgeons could perhaps be due to the different preconditions compared with a familiar working environment back home. The cleft panorama and the patient clientele in a less developed environment can differ greatly from a Western setting where patients are treated with presurgical molding and are operated upon at standardized ages. As a
Schonmeyr et al., EARLY COMPLICATIONS AFTER CLEFT LIP REPAIR ¨
consequence, the clefts may be wider and less aligned than one is used to, which may require adjustments of one’s standard surgical technique or wound closure under greater tension. The association between dehiscence and complete and bilateral clefts is not surprising and supports the assumption that excessive skin tension can cause dehiscence. In line with this, the bilateral complete clefts were distinctly overrepresented among the cases of dehiscence. Bromley et al. (1983) made a similar observation, where 5 (16%) of 31 patients with bilateral cleft lip suffered from dehiscence. We believe that extra precautions should be considered when treating patients with bilateral complete lip, and our regression analysis suggests that experienced surgeons should be assigned to these patients. Part of the permanent staff at our center uses a de-epithelialized strip of flanking dermis on both sides of the philtral flap, according to Mulliken (2001), to strengthen the suture line and prevent dehiscence. Presurgical molding, lip adhesion, or staged lip repair could also be considered, but for many patients in the less developed part of the world this is not a realistic option. Whether the setting is a mission or a center, many patients will have the opportunity to receive treatment only a limited number of times due to accessibility, loss of income, and so forth (Schwarz and Bhai Khadka, 2004; Adeyemo et al., 2009). According to our logistic regression analysis, wound infections were associated with complete clefts. An explanation for this could be that complete clefts need more extensive surgery, and the surgery involves the nose and oral cavity to a greater extent. Our findings are in support of Schettler (1973), who found a 13.3% infection rate if surgery was more than 2 hours compared with 5.1% if surgery time was less than 2 hours. Even though Schettler (1973) did not differentiate between lip and palate surgeries, our infection rate of 1.1% can be regarded as relatively low. Nagy and Mommaerts (2011) reported 8 patients (2.6%) of 302 primary cleft lip repairs with dehiscence and/or infection. The article did not distinguish between the two types of complications, but it was stated that five patients (1.6%) were treated with additional oral antibiotics, indicating an infectious component in these cases. Nagy’s postoperative wound care protocol included arm restraints, wound ointment, and dressings as well as postoperative intravenous and oral antibiotics. The use of these routines to decrease wound infections can perhaps be questioned, considering that our center seems to have a comparable incidence of wound infections without using any of these preventive measures. We do, however, feel that our patient education program, including basic instructions for post–op wound care, has brought our infection rates down. We have previously compared cleft missions, with or without this program, and found that infection
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rates were reduced from 3.7% to 0.4% (Schonmeyr et ¨ al., 2014). CONCLUSION In our series of 3108 primary lip repairs, we found a complication rate of 4.4% based on 2062 follow-ups. The most common complication was skin dehiscence, and this complication was significantly overrepresented among patients who had bilateral complete clefts. We therefore advise that extra precautions should be considered when operating upon bilateral complete clefts in this setting. Furthermore, these patients should be assigned to surgeons with experience with this type of clefts. We also found a low incidence of wound infection among our patients without the routine use of oral or local antibiotics postoperatively. Instead, we recommend educating patients in simple routines of hygiene and wound care before discharge. Acknowledgments. This study was carried out at the Guwahati Comprehensive Cleft Care Center (Assam, India), located at the Mahendra Mohan Choudhury Hospital, Guwahati. The authors acknowledge the support of Government of Assam, the National Rural Health Mission, the Sir Dorabji Tata Trust and Allied Trusts, Operation Smile International, and Operation Smile India for providing infrastructure and funding to ensure that all patients at this center are treated free of cost with no commercial or financial gains to any member of the team.
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