A wet dressing for hypospadias surgery

ARTICLE INFO _________________________________________________________ ___________________ Vol. 39 (3): 408-413, May June, 2013 doi: 10.1590/S1677-5538.IBJU.2013.03.15 IBJU | hypospadia surgery 409 The clinical indication of a specific dressing is based upon the protective function and mechanical barrier of the tissues against contamination and reduction of the edema caused by the surgical trauma. The structure material should present physical characteristics including elasticity, resistance and flexibility, and must adjust tightly on the surface of the tissues. The chosen dressing must present minimal adverse reactions when in contact with living tissues or organic fluids and must be easily removable. The main objective of the study was to prove that the biopolymer tape made of sugarcane molasses is biocompatible and protects the affected area in the same or better manner than the commercial available polyurethane tape (Tegaderm©) that is used nowadays for dressing after surgical correction of hypospadias. MATERIALS AND METHODS The target population included children and adolescents with hypospadias, and the parents were correctly informed about the study and were invited to join it. Thirty patients used the biopolymer tape as dressing and a similar group of patients used the polyurethane pellicle Tegaderm©. The groups ages varied between 1 and 18 years old, with a median age of 6.6 years for the group that used the sugarcane biopolymer and 7.4 for the group that used the polyurethane tape. The comparison of the two materials was made with the use a question form that allowed the evaluation of the results until complete recovery of the patients submitted to surgical correction of hypospadias. It was also analyzed local inflammatory reaction, edema, hyperemia, transudation and adhesiveness of the material to the surgical field until its removal. The evaluation of adverse reactions as skin irritability was categorized by the researcher observation as absent, limited to the foreskin, or extended to other areas. Grade of adhesiveness: the researcher observed the adhesiveness as with areas of detachment, adhesiveness without detachment or without adhesiveness. Grade of discomfort: the patients or their relatives described it during the questionnaire as “very troubled”, “troubled” or “not troubled” with the use of the dressing. Grade of adhesiveness and fixedness “in situ”: this aspect was evaluated after the patients or their relatives cleaned the dressing with water three times a day and informed the researcher. Sample size This was an experimental controlled and randomized clinical trial and the size of the sample included 60 patients, divided between two groups: group 1 (n = 30), patients submitted to surgical correction of hypospadias using biopolymer tape made of sugarcane molasses and group 2 (n = 30), patients that used the polyurethane pellicle as dressing. All patients were submitted to anamnesis including questions about previous surgeries, physical and urological exam and classification of the hypospadias grade, along with pre-operatory routine exams. There were 21 proximal hypospadias and 9 distals in the group that used the biopolymer tape. In the group that used the polyurethane pellicle, 19 presented proximal hypospadias and 11 distal. The patients were assigned randomly to the groups (use of biopolymer made of sugarcane molasses or polyurethane), through sealed envelopes containing numbered randomized distributions generated by computer in a 1:1 manner in groups of 10. The envelopes were opened at the surgical room by a nurse right before the surgical procedure. All volunteer patients were operated by one or more members of the surgical team. To make sure that all procedures were done properly all patients were hospitalized for 8 days. The polyurethane pellicles sized 4.4 x 4.4 and 6.0 x 7.0, were waterproof and protected against external contaminants, and were adequately fitted with comfort of all patients (Figure-1). The biopolymers tapes of sugarcane presented the same measures of the polyurethane pellicles and could be cut out according to the size of the patient organ (Figure-2). They were sterilized using gamma rays. IBJU | hypospadia surgery 410 Technique of pellicle application After completion of the surgical correction of the hypospadias according to several techniques, the area was washed with saline and dried with gauze. Then, the dressings were applied over the surgical field involving all penile surface (Figures 3a,b,c and d). There was no tension over the surgical field (Figure-4). Although they adhered correctly, three sutures were passed on the ends of the dressings using catgut 6-0, not including the skin, as a safety measure. No creams were used in both groups. In the group of patients with up to 7 years and that used a catheter, it was used a double diaper layer; the catheters were passed from a first to a second diaper through an opening, preventing the urine to be in touch with the dressing. In the group of boys more than 7 years old the urine drainage included a urethral catheter attached to a closed collecting system. Ethical Aspects This study did not present ethical risks and was in accordance to the determinations of the National Council of Health, the Helsinque Declararion and the Nuremberg Code for human experiment. The project was approved by the local Ethical Committee of the Institution. This was a randomized and controlled clinical experimental and observational trial.


INTRODUCTION
Surgical correction of male genitalia anomalies in children and adolescents has evolved in the last years with the use of new techniques, instruments and sutures, that somehow have contributed to better results.In spite of that, the correct choice of dressing is still challenging.Several materials have been used with various results, and there is no consensus about their use (1)(2)(3)(4)(5)(6)(7)(8)(9).
The clinical indication of a specific dressing is based upon the protective function and mechanical barrier of the tissues against contamination and reduction of the edema caused by the surgical trauma.The structure material should present physical characteristics including elasticity, resistance and flexibility, and must adjust tightly on the surface of the tissues.The chosen dressing must present minimal adverse reactions when in contact with living tissues or organic fluids and must be easily removable.
The main objective of the study was to prove that the biopolymer tape made of sugarcane molasses is biocompatible and protects the affected area in the same or better manner than the commercial available polyurethane tape (Te-gaderm©) that is used nowadays for dressing after surgical correction of hypospadias.

MATERIALS AND METHODS
The target population included children and adolescents with hypospadias, and the parents were correctly informed about the study and were invited to join it.Thirty patients used the biopolymer tape as dressing and a similar group of patients used the polyurethane pellicle Tegaderm©.The groups ages varied between 1 and 18 years old, with a median age of 6.6 years for the group that used the sugarcane biopolymer and 7.4 for the group that used the polyurethane tape.
The comparison of the two materials was made with the use a question form that allowed the evaluation of the results until complete recovery of the patients submitted to surgical correction of hypospadias.It was also analyzed local inflammatory reaction, edema, hyperemia, transudation and adhesiveness of the material to the surgical field until its removal.
The evaluation of adverse reactions as skin irritability was categorized by the researcher observation as absent, limited to the foreskin, or extended to other areas.
Grade of adhesiveness: the researcher observed the adhesiveness as with areas of detachment, adhesiveness without detachment or without adhesiveness.
Grade of discomfort: the patients or their relatives described it during the questionnaire as "very troubled", "troubled" or "not troubled" with the use of the dressing.
Grade of adhesiveness and fixedness "in situ": this aspect was evaluated after the patients or their relatives cleaned the dressing with water three times a day and informed the researcher.

Sample size
This was an experimental controlled and randomized clinical trial and the size of the sample included 60 patients, divided between two groups: group 1 (n = 30), patients submitted to surgical correction of hypospadias using biopolymer tape made of sugarcane molasses and group 2 (n = 30), patients that used the polyurethane pellicle as dressing.
All patients were submitted to anamnesis including questions about previous surgeries, physical and urological exam and classification of the hypospadias grade, along with pre-operatory routine exams.There were 21 proximal hypospadias and 9 distals in the group that used the biopolymer tape.In the group that used the polyurethane pellicle, 19 presented proximal hypospadias and 11 distal.
The patients were assigned randomly to the groups (use of biopolymer made of sugarcane molasses or polyurethane), through sealed envelopes containing numbered randomized distributions generated by computer in a 1:1 manner in groups of 10.The envelopes were opened at the surgical room by a nurse right before the surgical procedure.All volunteer patients were operated by one or more members of the surgical team.To make sure that all procedures were done properly all patients were hospitalized for 8 days.
The polyurethane pellicles sized 4.4 x 4.4 and 6.0 x 7.0, were waterproof and protected against external contaminants, and were adequately fitted with comfort of all patients (Figure -1).
The biopolymers tapes of sugarcane presented the same measures of the polyurethane pellicles and could be cut out according to the size of the patient organ (Figure -2).They were sterilized using gamma rays.

Technique of pellicle application
After completion of the surgical correction of the hypospadias according to several techniques, the area was washed with saline and dried with gauze.Then, the dressings were applied over the surgical field involving all penile surface (Figures 3a,b,c and  d).There was no tension over the surgical field (Figure-4).Although they adhered correctly, three sutures were passed on the ends of the dressings using catgut 6-0, not including the skin, as a safety measure.No creams were used in both groups.In the group of patients with up to 7 years and that used a catheter, it was used a double diaper layer; the catheters were passed from a first to a second diaper through an opening, preventing the urine to be in touch with the dressing.In the group of boys more than 7 years old the urine drainage included a urethral catheter attached to a closed collecting system.

Ethical Aspects
This study did not present ethical risks and was in accordance to the determinations of the Na-tional Council of Health, the Helsinque Declararion and the Nuremberg Code for human experiment.The project was approved by the local Ethical Committee of the Institution.This was a randomized and controlled clinical experimental and observational trial.

RESULTS
The follow-up evaluations were made by one of the members of the team daily until the removal of the dressing in the eighth day after the surgery before discharge (Figure -5).Eight parents of patients of the biopolymer group decided not to remove the dressing, allowing it to spontaneously fall, which occurred after 10 to 14 days, maintaining the recommendations of regular washes (Figure -6).All patients tolerated well the dressings in both groups.In one patient of the biopolymer group it was observed spontaneous fall of the dressing, one during the first day after the surgery and the other after three days of the surgery.There was significant edema in two patients of the Tegaderm© group, along with a foul odor resembling urine, according to relatives.Such cases were not observed in the biopolymer group.

DISCUSSION
There is no consensus about the correct dressing material for use during the post-operatory period of male patients with genital anomalies.Some groups advocate not to use any dressings and others use complex dressings with different grades of handling difficulties (10,11).
In a study from Canada, three groups of patients were compared.The median age was 2.2 years and all patients were submitted to surgical correction of different grades of hypospadias and used three different dressings: one with the same material used in the present study, one group using a porous material and a third group that did not use dressings.All patients used an ointment and the surgeries were made in a day hospital.The study did not establish the correct number of patients of each group.The dressing was removed by the parents after three days and the most important aspects was the urine odor and concerning about feces contamination.It concluded that dressings were not necessary in hypospadias surgeries (12).It is known that in minimal grades of hypospadias presenting minimal detachment of the foreskin, the same approach similar to postectomy can be applied, as stated by Leclair et al. (11).In the present study, there was no need of dressing exchange and it was possible to wash it as many times as needed, including the daily bath; the post-operatory handling was similar to those patients without dressings and the advantage that the surgical field is protected against external agents as feces.The fact that the studied material has already been studied regarding cytotoxicity and that it was used in other areas (including as  implants) makes it a safe option, with minimal undesired effects when applied to operated surfaces (13,14).It is important to reinforce that this material has been used in an uncontrolled manner for more than 5 years with good results (15).The present controlled study also studied prospectively the material and compared the results with previous reports.Since this material is multiperforated and transparent it is possible the observation of hematomas or areas of necrosis by the parents and doctors, that are very troublesome in male genitalia surgeries.The early withdrawal of the dressing as advocated by some (4,12) does not seem correct, since the development of edema will increase the tension in the sutured area and possible dehiscence.Another important aspect in the randomized trials is that the median age of the patients is low (less than 3 years old) in which group there seldom is observed erection (11,12).It seems possible that the use of a dressing with adequate contention of distension limits the occurrence of edema and its consequences on the surgical surface.As stated, the median age of the patients in our study was superior than the others.

CONCLUSIONS
Based on the present study it is possible to conclude that the proposed material is a highly satisfactory alternative.Since it is a product obtained from a renewable and natural source, possibly cheaper, its use is adequate for surgical dressing of hypospadias repair.

Figure 1 -Figure 2 -
Figure 1 -Polyurethane pellicle molded to the penile shaft.Figure 2 -Biopolymer pellicle made of sugarcane molded to the penile shaft.

Figure 3 a
Figure 3 a, b, c and d -Placement of the biopolymer pellicle of sugarcane, involving all penile surface.

Figure 4 -
Figure 4 -Schematic drawing of the application of the biopolymer pellicle of sugarcane.

Figure 6 -
Figure 6 -Spontaneous loss of the biopolymer tape after the 10 th day.