- Email: [email protected]
Cleft lip repair without suture removal
Journal of Plastic, Reconstructive & Aesthetic Surgery (2009) 62, 1161e1165
Cleft lip repair without suture removal* T.W. Collin a,*, K. Blyth b, P.D. Hodgkinson a a
Department of Plastic and Reconstructive Surgery, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UK b Department of Health Psychology, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UK Received 4 February 2008; accepted 16 March 2008
KEYWORDS Congenital cleft lip; Repair; Dermabond; Tissue adhesive; Sutures
Summary The disadvantages of using non-absorbable sutures in cleft lip repair include a need for additional dressings, return to the ward for removal of the sutures under sedation or general anaesthetic and the problem of distressing the child and potentially disrupting the repair. Modern medical adhesives represent an alternative adjunctive technique for skin closure and their use was adopted by this unit in 2005. A few ‘key’ interrupted sutures of 7/0 Vicryl Rapide followed by layers of a cyanoacrylate adhesive, Dermabond, were used instead of more traditional methods. An audit of the results of cleft lip repairs from this period of change was conducted. Subjective and objective data were collected and are presented to justify the continued use of this technique in the Newcastle Cleft Lip and Palate Unit. ª 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Congenital cleft lip repair is traditionally completed using a non-absorbable suture such as nylon or polypropylene. This presents the medical and nursing staff with the problem of removing these fine calibre sutures in small children. There has been concern about the safety of removing these sutures under sedation, on the ward, where no specific anaesthetic cover is provided for such an activity. The process is also potentially distressing and usually inconvenient for the families involved. *
Presented at The Craniofacial Society, Annual Scientific Meeting, Dublin, April 2007. * Corresponding author. Tel.: þ44 (0) 191 2829677; fax: þ44 (0) 191 2010155. E-mail address: [email protected] (T.W. Collin).
Descriptions of alternative techniques employing new materials seemed to offer a solution to the problems of traditional closures.1 A change in practice to incorporate these new ideas prompted this audit of the early results and a review of the impact to the cleft lip and palate service as a whole.
Materials and methods The change in practice for cleft lip skin closure occurred in May 2005. The results of cleft lip repairs for the year were reviewed. This review period incorporated a change in the method of skin closure: from interrupted Novafil sutures to Dermabond (octyl-2-cyanoacrylate) and 7/0 Vicryl Rapide. In all respects, apart from the skin closure,
1748-6815/$ - see front matter ª 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2008.03.028
1162 a standardised operative repair was performed, using rotation/advancement flaps, radical dissection and repositioning of muscle.2 Vomer flap closure of the hard palate was used in all patients. Application of the adhesive was performed after approximation of the skin edges with 7/0 Vicryl Rapide sutures in key positions. These were interrupted sutures with an external knot, one routinely placed in the white line with further sutures used only to create an everted edge. None of these sutures had to be removed. The product was applied in layers over the wound and adjacent skin with a short delay between each ‘coat’ (Figure 1). Moist gauze swabs were placed over the patients eyes to prevent the potential complication of accidental spillage on to the eyelids.3,4 At the same time the silicone nasal stents were sized, inserted and secured using the Dermabond, ensuring that they were not blocked with the adhesive. Nasal stents were also used in the Novafil group and were secured with sutures. A retrospective review of the case notes was performed. Data were collected regarding patient details, cleft type and repair technique, complications and length of stay. A review of the cost implications of this change in practice was based on the different materials used and the alterations in postoperative management; this included changes in length of inpatient stay and the reduced need for return to the ward for suture removal. An objective analysis of postoperative photographs was performed using a professional panel of five plastic surgeons. The panel were blinded to the type of repair which had been performed and were instructed to score the scar quality of each photograph using a visual analogue
T.W. Collin et al. scale (VAS). Ten photographs of sutured repairs and 10 photographs of glue repairs were presented for analysis, these were of the most mature scars, in each group, at the time of analysis. Statistical analysis of the results from this assessment were analysed using a Mann Whitney test. Subjective analysis of the parent and guardian satisfaction over this period was conducted in conjunction with the cleft lip and palate psychology service. A postal questionnaire was deemed an appropriate method of assessing basic levels of parental satisfaction. The parents/carers identified were sent the questionnaire by post with a covering letter explaining the purpose. The questionnaire included quantitative and qualitative measures of satisfaction for both cosmetic outcome and process rating. Levels of satisfaction were obtained on a simple four point scale: very dissatisfied, quite dissatisfied, quite satisfied and very satisfied. The questionnaire was succinct with opportunity for parents to expand upon their experiences if they chose to do so. Parents were directed to record retrospectively their levels of satisfaction at three stages; in the immediate postoperative period, 1 week later and once the lip was healed (at a time they determined the healing process to be complete). Parents were asked for any advice they would give to other parents about having their child’s lip repaired and for any additional comments they would like to make. The questionnaire provided parents with the opportunity to comment on aspects relevant to their personal experience to help identify any additional emerging themes from the results.
Results
Figure 1 Appearance of cleft lip repair after insertion of stents and application of adhesive.
This was a retrospective review of the results of consecutive cleft lip repairs performed in this unit in 2005. All of these repairs took place during the period from January to December 2005. The cohort consisted of 29 unilateral and seven bilateral congenital cleft lips. All operations were performed by a single surgeon (PDH). There were 14 patients in the Novafil repair group (Group 1) performed before May 2005 and 22 patients underwent repair with Dermabond and 7/0 Vicryl Rapide (Group 2) after that time. The patient details for each repair group are summarised in Tables 1 and 2. There were two complications within the study period. One patient returned to theatre in the early perioperative phase to explore a bleeding point in the palate where a vomer flap had been raised. The second complication, in the Novafil repair group, was the need for a general anaesthetic to remove the sutures in the lip after sedation on the ward had been unsuccessful. The length of stay in Group 1 was 4.9 days on average compared with 3.8 days in Group 2. Ten out of the 14 patients from Group 1 were readmitted as day cases for removal of sutures under sedation, travelling an average round-trip distance of 60 miles. The other four patients, in this group, were still inpatients at the time of suture removal. All Group 2 patients were visited at home, by the specialist cleft lip and palate nurses, as part of their
Cleft lip repair without suture removal Table 1
1163
Patient details for the Novafil repair group (Group 1)
Patient number
Gender
Age at repair (months)
Diagnostic group
Severity of cleft
1 2 3 4 5 6 7 8 9 10 11
Male Male Male Female Male Female Female Female Female Male Female
4 4 4 4 3 4 4 3 6 3 3
UCL UCLP UCL BCLP UCL UCL UCL UCLP BCLP UCL UCLP
Complete Incomplete Incomplete Complete Incomplete Incomplete Incomplete Complete Complete Incomplete Complete
12 13 14
Female Male Male
37 4 4
BCL UCL BCLP
Microform Microform Incomplete
Complications/ comments
Sedation failed; GA for ROS
Abbreviations: UCL, unilateral cleft lip; UCLP, unilateral cleft lip and palate; BCL, bilateral cleft lip; BLCP, bilateral cleft lip and palate; ROS, removal of sutures; GA, general anaesthetic.
routine check, 5 to 7 days after discharge. At this visit the nasal stents were removed and excess Dermabond was cleaned away. The parents in both groups were then advised to commence scar massage therapy using a combination of simple moisturising cream and a silicone-based product. The photographs selected for the assessment of scars were taken, on average, 49 weeks post operation (range
Table 2
26e103 weeks). The scores (from 1e10) recorded from the professional panel yielded non-parametric data from unpaired groups. The mean scores were 7.2 and 6.9 for Group 1 and Group 2, respectively. This did not yield a significant difference when applying the appropriate statistical tests (Table 3). The response from the feedback and satisfaction questionnaire was encouraging. Sixty-one per cent of the
Patient details for the Dermabond repair group (Group 2)
Patient number
Gender
Age at repair (months)
Diagnostic group
Severity of cleft
Complications/ comments
1
Female
4
UCLP
Complete
Return to theatre; bleeding
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Female Male Male Female Male Male Female Male Female Male Female Male Female Male Male Male Female Male Female Male Female
4 3 4 3 3 4 4 3 3 3 3 2 3 3 3 3 3 3 4 4 3
UCLP UCLP UCLP UCLP BCLP UCLP UCLP UCL UCL UCLP UCLP UCL UCL BCLP UCL UCL BCLP UCL UCLP UCLP UCLP
Complete Complete Complete Complete Complete Complete Complete Incomplete Incomplete Complete Incomplete Complete Incomplete Complete Incomplete Incomplete Complete Incomplete Incomplete Incomplete Complete
Abbreviations: UCL, unilateral cleft lip; UCLP, unilateral cleft lip and palate; BCL, bilateral cleft lip; BLCP, bilateral cleft lip and palate.
1164
T.W. Collin et al.
Table 3 Descriptive statistics for the visual analogue scale with significance testing with the Mann Whitney Test Panel results
Repair type
n
Mean rank Sum of ranks
Judge 1 score Suture repair 10 12.00 Glue repair 10 9.00 Total 20
120.00 90.00
Judge 2 score Suture repair 10 12.45 Glue repair 10 8.55 Total 20
124.50 85.50
Judge 3 score Suture repair 10 10.75 Glue repair 10 10.25 Total 20
107.50 102.50
Judge 4 score Suture repair 10 10.15 Glue repair 10 10.85 Total 20
101.50 108.50
Judge 5 score Suture repair 10 10.50 Glue repair 10 10.50 Total 20
105.00 105.00
Mean score ranks
Repair type
n
Mean rank (all judges)
Sum of mean ranks
Suture repair Glue repair Total
10 10 20
11.55 9.45
115.50 94.50
P value
0.436
questionnaires were returned. The quantitative data showed generally high levels of satisfaction with both procedures. There was no significant difference in levels of satisfaction depending on the type of repair. Results from respondents at each time period after repair can be seen in Figure 2. The free text responses from the parents were universally positive, these were as follows: we were impressed by the level of support from the team, baby was transformed, scar is very minor, (Surgeon) was extremely approachable and friendly, he (baby) even smiled the day after his lip op, we couldn’t have wished for anything better, after a few days baby not distressed or in pain because of no stitches (baby had glue repair).
hypertrophy8 and the protective barrier which helps to reduce bacterial colonisation of the wound. Overall our experience of using this adhesive for this application has been positive and with no specific complications related to its use. Subsequent to this analysis there has been one episode of Dermabond running into the periorbital area causing temporary eyelid adhesion. We are particularly careful to cover the eyes with gauze at this point of the procedure to avoid recurrence of this problem. The practice in this unit, before 2005, was to sedate these patients on the paediatric ward, as day-case admissions, and remove their sutures whilst anxious parents watched. The families had to travel back to the hospital for this, sometimes covering long distances, and many found the process distressing and inconvenient. In Group 1 the average mileage of a return trip was 60 miles for the 10 patients who returned. However, the other four families from the most distant parts of the region were given the option of remaining on the ward until the sutures were removed. This has the effect of increasing the length of stay in this group when compared with Group 2. This difference in length of stay is not unique to this year. Further analysis of length of stay data from 2004 and 2006 has shown a similar difference. This reduction in ward stay is one of the main influences in the cost reduction demonstrated in this review. The other factor implicated in cost reduction has been the abolition of day case admissions for sedation and suture removal. There were approximately 20 of these minor procedures per year. Overall, it was calculated, that it has been possible to reduce costs by up to £500 per patient. This is a considerable sum when calculated over the course of a year in which 35 to 40 cases would be performed. Results of the scar review by a professional panel did not show a significant difference in scar quality between the two groups. Equivalent mature wound cosmesis has been reported, using similar techniques, from other centres.5,6 However, the comparison does have some weaknesses. Namely that the number of patients was small (larger groups would add greater power to the calculations) and the groups were heterogeneous (with respect to diagnostic
10 9 very dissatisfied quite dissatisfied quite satisfied very satisfied
8 7
Discussion
6 5
Cyanoacrylates were first synthesised in 1949 and have been used clinically since 1959. The chemical structure of these compounds has been developed to create modern adhesives with longer chains (such as Dermabond) which are safe and easy to use. They have high tensile strength and are a suitable alternative for skin closure; demonstrating many advantages over suture repairs including excellent cosmetic outcome.1,5e7 The wound-healing benefits derive from the moist occluded environment, important for reducing scar
4 3 2 1 0 lue
me
im
e iat
su
d
me
im
Figure 2
lue
e
tur
eg
t dia
kg
1w
e e re tur glu utu su led d a e al he he
1
s wk
Parental satisfaction with lip scar.
Cleft lip repair without suture removal type) and not specifically age matched. This is due, in part, to the retrospective nature of an audit of this type and can only be rectified by a prospective review period. However, favourable aspects of our results include the fact that existing reports comparing these two methods have shown similar results.9,10 The method of data collection (visual analogue scales) and the scoring method are validated techniques.11 A further benefit of the change in this technique is the enhanced convenience for the families. All are visited at home by the specialist nurses in the early postoperative phase, to give advice about wound care, scar therapy, feeding problems and general reassurance where it is needed. Parents and children are not normally required to return to the hospital until the 6 week outpatient review; a great improvement in the service as a whole. The results from the parent questionnaire indicate high levels of satisfaction in both patient groups. As there is no significant difference it has been shown that glue repairs offer the same levels of satisfaction with the surgical result as sutured lip repairs. Comparing experiences is constrained by the patient only having their own experience to reflect upon, which in this case is either the use of sutures or glue. It was not possible to complete more detailed interviews with any parents who have experienced both types of surgical repair. Further study of parental satisfaction could include semi-structured interviews and focus groups to compare the different methods of lip repair. This would yield richer data for further analysis and greater comparison. Postal questionnaires are limited by the lack of clarification possible and by nature remain simple in design. Nevertheless, the results of the parent questionnaire indicate high levels of satisfaction with the outcome and process, further supporting the decision to adopt glue repairs for congenital cleft lip. In conclusion, the results of this review have justified, in our opinion, the change from sutures to an adhesive-based skin repair in cleft lip surgery. We have been encouraged by the cosmetic results, the favourable cost implications and
1165 the positive feedback received from the patients. There is a need for continued review and audit of the process as these are only the early findings. Nevertheless, this technique is now established as ‘standard practice’ in the unit.
Acknowledgement The authors of this paper have no financial interest in Dermabond.
References 1. Magee Jr WP, Ajkay N, Githae B, et al. Use of octyl-2cyanoacrylate in cleft lip repair. Ann Plast Surg 2003 Jan;50: 1e5. 2. Millard RD. Cleft Craft: The Evolution of its Surgery. Boston: Little, Brown; 1980. 3. Resch KL, Hick JL. Preliminary experience with octyl-2cyanoacrylate in a paediatric emergency department. Pediatr Emerg Care 2000;16:328e31. 4. Yamamoto LG. Preventing adverse events and outcomes encountered using Dermabond. Am J Emerg Med 2000;18:511e5. 5. Knott PD, Zins JE, Banbury J, et al. A comparison of dermabond tissue adhesive and sutures in the primary repair of the congenital cleft lip. Ann Plast Surg 2007 Feb;58:121e5. 6. Spauwen PH, de Laat WA, Hartman EH. Octyl-2-cyanoacrylate tissue glue (Dermabond) versus Monocryl 6/0 sutures in lip closure. Cleft Palate Craniofac J 2006 Sep;43:625e7. 7. Cooper JM, Paige KT. Primary and revision cleft lip repairs using octyl-2-cyanoacrylate. J Craniofac Surg 2006 Mar;17:340e3. 8. Sawada Y, Sone K. Hydration and occlusion treatment for hypertrophic scars and keloids. Br J Plast Surg 1992 NoveDec; 45:599e603. 9. Toriumi DM, O’Grady K, Desai D, et al. Use of octyl-2-cyanoacrylate for skin closure in facial plastic surgery. Plast Reconstr Surg 1998 Nov;102:2209e19. 10. Quinn JV, Drzewiecki AE, Stiell IG, et al. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med 1995;13:229e31. 11. Saxby PJ, Palmer JH. The use of an independent panel to assess the long term results of cleft lip repair. Br J Plast Surg 1986 Jul;39:373e8.
Cleft lip repair without suture removal* T.W. Collin a,*, K. Blyth b, P.D. Hodgkinson a a
Department of Plastic and Reconstructive Surgery, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UK b Department of Health Psychology, Royal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, UK Received 4 February 2008; accepted 16 March 2008
KEYWORDS Congenital cleft lip; Repair; Dermabond; Tissue adhesive; Sutures
Summary The disadvantages of using non-absorbable sutures in cleft lip repair include a need for additional dressings, return to the ward for removal of the sutures under sedation or general anaesthetic and the problem of distressing the child and potentially disrupting the repair. Modern medical adhesives represent an alternative adjunctive technique for skin closure and their use was adopted by this unit in 2005. A few ‘key’ interrupted sutures of 7/0 Vicryl Rapide followed by layers of a cyanoacrylate adhesive, Dermabond, were used instead of more traditional methods. An audit of the results of cleft lip repairs from this period of change was conducted. Subjective and objective data were collected and are presented to justify the continued use of this technique in the Newcastle Cleft Lip and Palate Unit. ª 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Congenital cleft lip repair is traditionally completed using a non-absorbable suture such as nylon or polypropylene. This presents the medical and nursing staff with the problem of removing these fine calibre sutures in small children. There has been concern about the safety of removing these sutures under sedation, on the ward, where no specific anaesthetic cover is provided for such an activity. The process is also potentially distressing and usually inconvenient for the families involved. *
Presented at The Craniofacial Society, Annual Scientific Meeting, Dublin, April 2007. * Corresponding author. Tel.: þ44 (0) 191 2829677; fax: þ44 (0) 191 2010155. E-mail address: [email protected] (T.W. Collin).
Descriptions of alternative techniques employing new materials seemed to offer a solution to the problems of traditional closures.1 A change in practice to incorporate these new ideas prompted this audit of the early results and a review of the impact to the cleft lip and palate service as a whole.
Materials and methods The change in practice for cleft lip skin closure occurred in May 2005. The results of cleft lip repairs for the year were reviewed. This review period incorporated a change in the method of skin closure: from interrupted Novafil sutures to Dermabond (octyl-2-cyanoacrylate) and 7/0 Vicryl Rapide. In all respects, apart from the skin closure,
1748-6815/$ - see front matter ª 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2008.03.028
1162 a standardised operative repair was performed, using rotation/advancement flaps, radical dissection and repositioning of muscle.2 Vomer flap closure of the hard palate was used in all patients. Application of the adhesive was performed after approximation of the skin edges with 7/0 Vicryl Rapide sutures in key positions. These were interrupted sutures with an external knot, one routinely placed in the white line with further sutures used only to create an everted edge. None of these sutures had to be removed. The product was applied in layers over the wound and adjacent skin with a short delay between each ‘coat’ (Figure 1). Moist gauze swabs were placed over the patients eyes to prevent the potential complication of accidental spillage on to the eyelids.3,4 At the same time the silicone nasal stents were sized, inserted and secured using the Dermabond, ensuring that they were not blocked with the adhesive. Nasal stents were also used in the Novafil group and were secured with sutures. A retrospective review of the case notes was performed. Data were collected regarding patient details, cleft type and repair technique, complications and length of stay. A review of the cost implications of this change in practice was based on the different materials used and the alterations in postoperative management; this included changes in length of inpatient stay and the reduced need for return to the ward for suture removal. An objective analysis of postoperative photographs was performed using a professional panel of five plastic surgeons. The panel were blinded to the type of repair which had been performed and were instructed to score the scar quality of each photograph using a visual analogue
T.W. Collin et al. scale (VAS). Ten photographs of sutured repairs and 10 photographs of glue repairs were presented for analysis, these were of the most mature scars, in each group, at the time of analysis. Statistical analysis of the results from this assessment were analysed using a Mann Whitney test. Subjective analysis of the parent and guardian satisfaction over this period was conducted in conjunction with the cleft lip and palate psychology service. A postal questionnaire was deemed an appropriate method of assessing basic levels of parental satisfaction. The parents/carers identified were sent the questionnaire by post with a covering letter explaining the purpose. The questionnaire included quantitative and qualitative measures of satisfaction for both cosmetic outcome and process rating. Levels of satisfaction were obtained on a simple four point scale: very dissatisfied, quite dissatisfied, quite satisfied and very satisfied. The questionnaire was succinct with opportunity for parents to expand upon their experiences if they chose to do so. Parents were directed to record retrospectively their levels of satisfaction at three stages; in the immediate postoperative period, 1 week later and once the lip was healed (at a time they determined the healing process to be complete). Parents were asked for any advice they would give to other parents about having their child’s lip repaired and for any additional comments they would like to make. The questionnaire provided parents with the opportunity to comment on aspects relevant to their personal experience to help identify any additional emerging themes from the results.
Results
Figure 1 Appearance of cleft lip repair after insertion of stents and application of adhesive.
This was a retrospective review of the results of consecutive cleft lip repairs performed in this unit in 2005. All of these repairs took place during the period from January to December 2005. The cohort consisted of 29 unilateral and seven bilateral congenital cleft lips. All operations were performed by a single surgeon (PDH). There were 14 patients in the Novafil repair group (Group 1) performed before May 2005 and 22 patients underwent repair with Dermabond and 7/0 Vicryl Rapide (Group 2) after that time. The patient details for each repair group are summarised in Tables 1 and 2. There were two complications within the study period. One patient returned to theatre in the early perioperative phase to explore a bleeding point in the palate where a vomer flap had been raised. The second complication, in the Novafil repair group, was the need for a general anaesthetic to remove the sutures in the lip after sedation on the ward had been unsuccessful. The length of stay in Group 1 was 4.9 days on average compared with 3.8 days in Group 2. Ten out of the 14 patients from Group 1 were readmitted as day cases for removal of sutures under sedation, travelling an average round-trip distance of 60 miles. The other four patients, in this group, were still inpatients at the time of suture removal. All Group 2 patients were visited at home, by the specialist cleft lip and palate nurses, as part of their
Cleft lip repair without suture removal Table 1
1163
Patient details for the Novafil repair group (Group 1)
Patient number
Gender
Age at repair (months)
Diagnostic group
Severity of cleft
1 2 3 4 5 6 7 8 9 10 11
Male Male Male Female Male Female Female Female Female Male Female
4 4 4 4 3 4 4 3 6 3 3
UCL UCLP UCL BCLP UCL UCL UCL UCLP BCLP UCL UCLP
Complete Incomplete Incomplete Complete Incomplete Incomplete Incomplete Complete Complete Incomplete Complete
12 13 14
Female Male Male
37 4 4
BCL UCL BCLP
Microform Microform Incomplete
Complications/ comments
Sedation failed; GA for ROS
Abbreviations: UCL, unilateral cleft lip; UCLP, unilateral cleft lip and palate; BCL, bilateral cleft lip; BLCP, bilateral cleft lip and palate; ROS, removal of sutures; GA, general anaesthetic.
routine check, 5 to 7 days after discharge. At this visit the nasal stents were removed and excess Dermabond was cleaned away. The parents in both groups were then advised to commence scar massage therapy using a combination of simple moisturising cream and a silicone-based product. The photographs selected for the assessment of scars were taken, on average, 49 weeks post operation (range
Table 2
26e103 weeks). The scores (from 1e10) recorded from the professional panel yielded non-parametric data from unpaired groups. The mean scores were 7.2 and 6.9 for Group 1 and Group 2, respectively. This did not yield a significant difference when applying the appropriate statistical tests (Table 3). The response from the feedback and satisfaction questionnaire was encouraging. Sixty-one per cent of the
Patient details for the Dermabond repair group (Group 2)
Patient number
Gender
Age at repair (months)
Diagnostic group
Severity of cleft
Complications/ comments
1
Female
4
UCLP
Complete
Return to theatre; bleeding
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Female Male Male Female Male Male Female Male Female Male Female Male Female Male Male Male Female Male Female Male Female
4 3 4 3 3 4 4 3 3 3 3 2 3 3 3 3 3 3 4 4 3
UCLP UCLP UCLP UCLP BCLP UCLP UCLP UCL UCL UCLP UCLP UCL UCL BCLP UCL UCL BCLP UCL UCLP UCLP UCLP
Complete Complete Complete Complete Complete Complete Complete Incomplete Incomplete Complete Incomplete Complete Incomplete Complete Incomplete Incomplete Complete Incomplete Incomplete Incomplete Complete
Abbreviations: UCL, unilateral cleft lip; UCLP, unilateral cleft lip and palate; BCL, bilateral cleft lip; BLCP, bilateral cleft lip and palate.
1164
T.W. Collin et al.
Table 3 Descriptive statistics for the visual analogue scale with significance testing with the Mann Whitney Test Panel results
Repair type
n
Mean rank Sum of ranks
Judge 1 score Suture repair 10 12.00 Glue repair 10 9.00 Total 20
120.00 90.00
Judge 2 score Suture repair 10 12.45 Glue repair 10 8.55 Total 20
124.50 85.50
Judge 3 score Suture repair 10 10.75 Glue repair 10 10.25 Total 20
107.50 102.50
Judge 4 score Suture repair 10 10.15 Glue repair 10 10.85 Total 20
101.50 108.50
Judge 5 score Suture repair 10 10.50 Glue repair 10 10.50 Total 20
105.00 105.00
Mean score ranks
Repair type
n
Mean rank (all judges)
Sum of mean ranks
Suture repair Glue repair Total
10 10 20
11.55 9.45
115.50 94.50
P value
0.436
questionnaires were returned. The quantitative data showed generally high levels of satisfaction with both procedures. There was no significant difference in levels of satisfaction depending on the type of repair. Results from respondents at each time period after repair can be seen in Figure 2. The free text responses from the parents were universally positive, these were as follows: we were impressed by the level of support from the team, baby was transformed, scar is very minor, (Surgeon) was extremely approachable and friendly, he (baby) even smiled the day after his lip op, we couldn’t have wished for anything better, after a few days baby not distressed or in pain because of no stitches (baby had glue repair).
hypertrophy8 and the protective barrier which helps to reduce bacterial colonisation of the wound. Overall our experience of using this adhesive for this application has been positive and with no specific complications related to its use. Subsequent to this analysis there has been one episode of Dermabond running into the periorbital area causing temporary eyelid adhesion. We are particularly careful to cover the eyes with gauze at this point of the procedure to avoid recurrence of this problem. The practice in this unit, before 2005, was to sedate these patients on the paediatric ward, as day-case admissions, and remove their sutures whilst anxious parents watched. The families had to travel back to the hospital for this, sometimes covering long distances, and many found the process distressing and inconvenient. In Group 1 the average mileage of a return trip was 60 miles for the 10 patients who returned. However, the other four families from the most distant parts of the region were given the option of remaining on the ward until the sutures were removed. This has the effect of increasing the length of stay in this group when compared with Group 2. This difference in length of stay is not unique to this year. Further analysis of length of stay data from 2004 and 2006 has shown a similar difference. This reduction in ward stay is one of the main influences in the cost reduction demonstrated in this review. The other factor implicated in cost reduction has been the abolition of day case admissions for sedation and suture removal. There were approximately 20 of these minor procedures per year. Overall, it was calculated, that it has been possible to reduce costs by up to £500 per patient. This is a considerable sum when calculated over the course of a year in which 35 to 40 cases would be performed. Results of the scar review by a professional panel did not show a significant difference in scar quality between the two groups. Equivalent mature wound cosmesis has been reported, using similar techniques, from other centres.5,6 However, the comparison does have some weaknesses. Namely that the number of patients was small (larger groups would add greater power to the calculations) and the groups were heterogeneous (with respect to diagnostic
10 9 very dissatisfied quite dissatisfied quite satisfied very satisfied
8 7
Discussion
6 5
Cyanoacrylates were first synthesised in 1949 and have been used clinically since 1959. The chemical structure of these compounds has been developed to create modern adhesives with longer chains (such as Dermabond) which are safe and easy to use. They have high tensile strength and are a suitable alternative for skin closure; demonstrating many advantages over suture repairs including excellent cosmetic outcome.1,5e7 The wound-healing benefits derive from the moist occluded environment, important for reducing scar
4 3 2 1 0 lue
me
im
e iat
su
d
me
im
Figure 2
lue
e
tur
eg
t dia
kg
1w
e e re tur glu utu su led d a e al he he
1
s wk
Parental satisfaction with lip scar.
Cleft lip repair without suture removal type) and not specifically age matched. This is due, in part, to the retrospective nature of an audit of this type and can only be rectified by a prospective review period. However, favourable aspects of our results include the fact that existing reports comparing these two methods have shown similar results.9,10 The method of data collection (visual analogue scales) and the scoring method are validated techniques.11 A further benefit of the change in this technique is the enhanced convenience for the families. All are visited at home by the specialist nurses in the early postoperative phase, to give advice about wound care, scar therapy, feeding problems and general reassurance where it is needed. Parents and children are not normally required to return to the hospital until the 6 week outpatient review; a great improvement in the service as a whole. The results from the parent questionnaire indicate high levels of satisfaction in both patient groups. As there is no significant difference it has been shown that glue repairs offer the same levels of satisfaction with the surgical result as sutured lip repairs. Comparing experiences is constrained by the patient only having their own experience to reflect upon, which in this case is either the use of sutures or glue. It was not possible to complete more detailed interviews with any parents who have experienced both types of surgical repair. Further study of parental satisfaction could include semi-structured interviews and focus groups to compare the different methods of lip repair. This would yield richer data for further analysis and greater comparison. Postal questionnaires are limited by the lack of clarification possible and by nature remain simple in design. Nevertheless, the results of the parent questionnaire indicate high levels of satisfaction with the outcome and process, further supporting the decision to adopt glue repairs for congenital cleft lip. In conclusion, the results of this review have justified, in our opinion, the change from sutures to an adhesive-based skin repair in cleft lip surgery. We have been encouraged by the cosmetic results, the favourable cost implications and
1165 the positive feedback received from the patients. There is a need for continued review and audit of the process as these are only the early findings. Nevertheless, this technique is now established as ‘standard practice’ in the unit.
Acknowledgement The authors of this paper have no financial interest in Dermabond.
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