Evaluation of efficacy of oxygen-enriched oil-based gel dressing in patients who underwent surgical repair of distal hypospadias: a prospective randomised clinical trial

Abstract

Purpose This study aimed to evaluate the efficacy of oxygen-enriched oil-based gel dressing on wound healing and postoperative outcome in children who underwent distal hypospadias repair. Methods We included all patients with distal hypospadias, who underwent Snodgrass urethroplasty and preputioplasty over an 18-months period. The patients were randomized in two groups according to the type of medication: oxygen-enriched oil-based gel (G1) and hyaluronic acid cream (G2). After discharge, parents changed the dressing twice a day for 2-3 weeks postoperatively. The patients were evaluated at 7, 14, 21, 30, 60 and 180 postoperative days and thereafter annually. Results One-hundred and fourteen patients (median age 18 months) were included in the study and randomized in two groups, each of 57 patients. The wound healing was significantly faster in G1 compared with G2 (p = 0.001). G1 reported significantly higher SWAS and modified HOPE scores compared with G2 (p = 0.001) at all steps of follow-up. No adverse skin reactions occurred. Foreskin dehiscence and re-operations rates were significantly lower in G1 compared with G2 (p = 0.001). Postoperative foreskin retractability was better in G1, with a significantly higher incidence of secondary phimosis in G2 (p = 0.001). The median treatment costs were significantly lower in G1 compared with G2 (p = 0.001). Conclusion Postoperative dressing using oxygen-enriched oil-based gel was highly effective, promoting a faster wound healing in patients who underwent distal hypospadias repair. It reported a lower incidence of foreskin dehiscence and better foreskin retractability compared with the control group. It was cost-effective and clinically safe without allergy or intolerance to the product.

Risks of ozonated oil and ozonated water on human skin: A systematic review

“…Five studies aimed to evaluate the efficacy of liquid forms of O 3 in clinical therapeutic applications and provided information on post hoc examination or patient self-report of side effects. 4,7,11,12,22 Three of the five studies found no indications of adverse effects from ozonated liquids. Of the 433 participants in these studies, only one patient reported desquamation and an unclear number of patients reported a transient burning sensation upon application.…”

“…1,3 Ozonated liquids have been used in industrial and residential applications that exploit ozone's oxidising capabilities. 4 The broad applications for these liquid formulations have included everything from food preparation to decontamination of water pipes. O 3 liquids have gained attention in the literature for many clinical applications, including wound care.…”

Evaluation of a New Tubular Finger Oxygen-Enriched Oil Inside-Coated Dressing Device in Pediatric Patients Undergoing Distal Hypospadias Repair: A Prospective Randomized Clinical Trial Part II

“…After completing the surgical correction of the hypospadias, the area was washed with saline and dried with gauze. In G2 patients, as already described in the previous study (15), a layer of oxygen-enriched oil-based gel was directly applied on a wet gauze composed by hyaluronic acid. This impregnated gauze was wrapped around the penis and subsequently covered by an elastic net bandage to obtain hemorrhage compressive effect.…”

“…The primary endpoint of the study was to compare the two groups about the wound healing time defined as the time to return to normal structure and appearance of the penis following surgery. The wound healing was scored using the Southampton Wound Assessment Scale (SWAS) (15), that evaluated normal healing (grade 0), normal healing with mild bruising or erythema (grade 1), presence of erythema plus other signs of inflammation (grade 2), clear or hemo-serous discharge (grade 3), or major complications such as pus (grade 4) and deep or severe wound infection with or without tissue breakdown or hematoma requiring aspiration (grade 5) ( Table 1).…”

“…We recently published a prospective randomized clinical trial reporting the efficacy of oxygen-enriched oil-based gel associated with an elastic band dressing on the post-operative wound healing outcome of children undergoing distal hypospadias repair (15).…”