A wet dressing for male genital surgery: A phase II clinical trial

Open, non-controlled clinical study of phase II. A total of 141 patients, among those children, adolescents and adults with hypospadias (112), epispadias (04), phymosis (13) and Peyronie's disease (¹²12. Van Savage JG, Palanca LG, Slaughenhoupt BL. A prospective randomized trial of dressings versus no dressings for hypospadias repair. J Urol. 2000;164:981–3.) that had a BC dressing applied over the operated area after surgery. A written informed consent was obtained from all participants. Study exclusion criteria were patients with other alternative treatment indications due to the severity, extent of the injury or the underlying disease. The outcomes evaluated were efficacy, safe and complete healing. The costs were discussed.

Results:

In 68% patients, the BC dressing fell off spontaneously. The BC was removed without complications in 13% of patients at the outpatient clinic during the follow-up visit and 17% not reported the time of removal. In 3% of the cases, the dressing fell off early. Complete healing was observed between 8th and 10th days after surgery. The BC dressings have shown a good tolerance by all the patients and there were no reports of serious adverse events.

Conclusion:

The bacterial cellulose dressings have shown efficacy, safety and that can be considered as a satisfactory alternative for postoperative wound healing in urogenital area and with low cost.

Keywords:
Safety; Surgical Procedures, Operative; Genitalia, Male

Disease	N	Hospitalization (N days)	Age (average/years)	Time to Dressing Removal (day)
				Fell off Spontaneously			Removed	Not Informed
				1st^* * The dressing was reapplied and remained until 11th day.	9th - 10th	11th - 14th	8th – 10th	Not Informed
Hypospadias	112	10	5.4	2	66	25	0	19
Epispadias	4			0	0	3	0	1
Phymosis	13	0	14.7	2	0	1	6	4
Peyronie's	12	2	53.6	0	0	0	12	0
Total	141	10		4	66	29	18	24
(%)				3%	47%	21%	13%	17%

Outcomes		Phase I Study (Hypospadias)		Phase II Study (Hypospadias, Epispadias, Phymosis and Peyronie's Disease)
		Polyurethane	BC	BC	p-value	RR	IC 95%
	N° of patients	30	30	141	-	-	-
SAFETY	Adverse events:
	Hyperemia	0	1 (3.3%)	5 (3.6%)	0.6120^a	1.556	0.8304–2.914
	Hyperemia/Edema	2 (6.7%)	0	0	0.1471^b	2.264	0.8678–5.906
	Edema	1 (3.3%)	0	0	1.0000^c	0.9483	0.1537–5.852
EFFICACY	Adherence degree:
	Fully adhered	30 (100%)	28 (93.3%)	137 (97.2%)	-	-	-
	Partially detached	0	2 (6.7%)	2 (1.4%)	0.4915^a	-	-
					1.0000^b	-	-
					0.1453^c	0.3394	0.1204–0.9571
	Difficulty removed	3 (10%)	0	0	0.2373^a	2.111	1.606–2.776
					0.0050^b^* * Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.	6.222	4.404–8.791
	Early dressing fall	0	2 (6.7%)	4 (2.8%)	0.4915^a	-	-
					1.0000^b	-	-
					0.3105^c	0.5419	0.1664–1.765
	Pain and discomfort:
	Uncomfortable	23 (76.7%)	24 (80%)	88 (62.4%)	1.0000^a	0.9088	0.5078–1.626
	Not a problem	7 (23.3%)	6 (20%)	53 (37.6%)	0.2054^b	1.776	0.8095–3.897
					0.0898^c	2.107	0.9120–4.868
	Use of analgesic:
	In the 1^st p.o.	20 (66.7%)	21 (70%)	70 (49.6%)	1.0000^a	0.9268	0.5458–1.574
					0.1086^b	1.800	0.8962–3.615
					0.0463^c^* * Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.	2.051	0.9975–4.218
	After 1^st p.o.	8 (26.7%)	6 (20%)	20 (14.2%)	0.7611^a	1.195	0.6928–2.061
					0.1062^b	1.857	0.9216–3.742
					0.4095^c	1.394	0.6319–3.076
	At dressing removal	3 (10%)	0	0	0.2373^a	2.111	1.606–2.776
					0.0050^b^* * Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.	6.222	4.404–8.791
	Healing (time)
	8^th-10^th	9 (30%)	22 (73.3%)	84 (59.6%)	0.0017^a^* * Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.	0.4009	0.2212–0.7266
	11^th-14^th	21 (70%)	8	33 (23.4%)	<0.0001b^* * Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.	0.2488	0.1229–0.5038
			(26.7%)		1.0000^c	1.064	0.5153–2.195

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[1] Correspondence address: Flávia Cristina Morone Pinto, PhD, Departamento de Cirurgia do Centro de Ciências da Saúde, Universidade Federal de Pernambuco, UFPE, Brasil, Av. Prof. Moraes Rego, 1235, Cidade Universitária, Recife, PE, 50670-901, Brasil, Fax: +55 81 2126-3649, E-mail: fcmorone@gmail.com