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OBJECTIVE

In this pilot study, two all-in-one multicomponent compression systems designed for use in phlebological diseases were evaluated for their sub-bandage resting and working pressure performance, static stiffness index, and wearing acceptance over the course of one week in a cohort of healthy volunteers.

METHOD

This was a prospective, monocentric, observational, within-person randomised controlled pilot comparison study. The investigational device (InD) and the comparator device (CoD) were randomly applied to the lower legs of the participants for continuous wear, both during the day and night, for one week. The sub-bandage resting and working pressures were measured on four visits by pneumatic pressure sensors applied underneath the bandages (day of application, day 1, day 3 and final day). The height of the bandage from the foot sole to the bandage rim was measured to determine the bandage slippage over time. Participants were asked to assess comfort during and at the end of enrolment. The investigators evaluated the padding and skin protection effect of the bandages for each participant.

RESULTS

A total of 22 healthy volunteers took part in the study. A mean resting and working pressure within the relevant therapeutic range of 20-40mmHg was achieved with both bandage systems. At application, the mean pressures were 46mmHg with both bandages and dropped to within the therapeutic range by the next day. The mean bandage slippage with both bandages was <5cm on the third day. Both bandages were well tolerated, except for itching, which was experienced significantly more with the CoD than with the InD (mean tolerance rating of at least 'acceptable' in 83% (InD) and 67% (CoD) of participants, as measured on a four-point scale). The participants confirmed 'satisfactory' or greater wearing comfort and ankle mobility (mean rating: 89% (InD) and 93% (CoD) of participants, as measured on a six-point scale).

CONCLUSION

Both bandages achieved therapeutic working pressures and tolerable resting pressures. Both products were well tolerated. Confirmation in a larger cohort of patients with venous leg ulcers in a real-world setting reflecting clinical routine is recommended. The study is registered with ClinicalTrials.gov database (ID NCT06728137).

OBJECTIVE

To compare the static stiffness index (SSI) between a compression garment and a ReadyWrap (Venosan, Brazil) adjustable compression garment (ACG), and analyse the clinical factors associated with increased SSI in patients with breast cancer-related lymphoedema (BCRL).

METHOD

In this cross-sectional study, working pressure (WP) and resting pressure (RP) were assessed using a PicoPress device (Venosan, Brazil) positioned under the biceps muscle in the arm region. The SSI was calculated as the absolute and relative difference between the RP and the highest WP recorded during muscle contraction.

RESULTS

The study included 76 patients with a mean age of 61.7±12.6 years. During compression garment use, the mean RP was 21.9mmHg and mean WP was 40.0mmHg during biceps brachii contraction, resulting in an absolute SSI of 18.1mmHg and a relative SSI of 43.6% (p<0.001). For the ACG, the mean RP was 19.3mmHg and mean WP was 63.1mmHg, resulting in a mean SSI of 43.8mmHg and a relative SSI of 68.7% (p<0.001). The ACG produced an SSI 25.7mmHg greater than the compression garment, a 25.1% relative difference (p<0.001). The compression garment showed a higher SSI in early-stage versus advanced-stage patients (8.2%; p=0.003) and in those with conservative surgeries versus mastectomy (8.3%; p=0.005). No SSI difference was observed for the ACG when considering tumour characteristics and oncological treatment.

CONCLUSION

The SSI was greater with ACG use compared with the compression garment. Patients who had breast-conserving surgeries and early-stage tumours showed the highest SSI when using the compression garment. No SSI differences were found regarding patient demographic, clinical, tumour or treatment characteristics during ACG use.

BACKGROUND

Omphalocele is a congenital abdominal wall defect that causes the protrusion of the abdominal organs at the base of the umbilical cord, which is covered by a membranous sac composed of the peritoneum and amnion. We report the case of a newborn with a giant omphalocele containing the liver and bowel loops who underwent staged surgical closure followed by negative pressure wound therapy (NPWT) for the management of skin wound dehiscence.

CASE PRESENTATION

A male Caucasian infant was born at 35 weeks by elective cesarean section due to a prenatal diagnosis of a giant omphalocele. The clinical examination at birth confirmed a giant omphalocele with extensive liver and small bowel content. Cardio-respiratory and neurological examinations were unremarkable. The omphalocele was initially wrapped with hydrocolloid dressings. After bowel content reduction and epithelialization of the membrane, a three-stage surgery was scheduled as follows: first, a silo bag was fashioned (on day 22); then, after complete liver reduction, the wide muscle-fascial defect was temporarily covered by a porcine dermal implant to close the gap (on day 32); finally, the abdominal wall was fully closed without prosthetic material using the component separation method (on day 68). NPWT was performed in two stages for a total of 29 days. The first period, applied between the second and third interventions, began on day 37 and continued for 16 days. Due to partial dehiscence of the surgical wound, NPWT was restarted on day 75 for 13 days, with increasing pressure (from -20 to -40 mmHg). Progressive improvement of the wound was obtained. After NPWT removal, an antimicrobial hydro-balanced dressing was placed on the wound.

CONCLUSIONS

This case underlines the lack of a standardized therapeutic approach for complex abdominal wall defects. It also highlights the efficacy of NPWT in complicated surgical wounds in infancy, given the reduction in dressing frequency and related stress. Furthermore, NPWT guarantees a significant reduction in the number of days required for the resolution of the surgical wound.

BACKGROUND

Necrotizing enterocolitis (NEC) totalis is a devastating intestinal disease that affects ~ 5% of preterm neonates; its appropriate surgical management is still controversial. Although the temporary open abdomen associated with negative pressure wound therapy (NPWT) has become an increasingly used therapeutic option, its use is still relatively limited in premature babies with NEC.

CASE REPORT

On the 6th day of life a male preterm neonate born at 32 + 3 weeks of gestational age (1570 g) developed bowel perforation. He underwent a bed-side laparotomy and a NEC totalis was found with three intestinal perforations (one jejunal and two contiguous ileal perforations). In order to re-esplore the baby, an open abdomen NPWT was applied (Suprasorb CNP P3-Lohmann-Rauscher), with an intrabdominal drainage film, setting the pressure at -20 mmHg. After 72 h a second surgery was performed. The entire bowel showed a good trophism; no new perforations were found. The two ileal perforations were closed with running sutures and a jejunostomy was performed. The postoperative course was uneventful and the oral feeding started on the fifth postoperative day. Two months later a barium enema through the mucous fistula showed a normal intestinal progression of the contrast medium, and the jejunostomy was closed.

CONCLUSION

The temporary open abdomen associated with NPWT is a valuable resource in critical premature neonates; it allows the creation of a “artificial third space” which is crucial in lowering bowel edema and intrabdominal pressure. Moreover, the use of an intrabdominal film may represent a new perspective whose effectiveness needs further studies.

Surgical wounds and periwound skin require protection to prevent complications, which affect clinical outcomes and patient quality of life. This study surveyed 45 health professionals treating 394 patients to elicit their experiences of the performance, quality, ease of application and usability of the sterile surgical wound dressing Curapor under routine conditions. Most (90%) wounds were acute, including postoperative wounds, lacerations, cuts and abrasions. The average wear time per dressing was 2.08 days; 94% of patients experienced no dressing slippage and 98% experienced no tape blisters. Curapor was rated good at absorbing exudate. All health professionals reported that their patients thought the dressing was soft or very soft and 98% said that patients found its comfort to be good or very good. The results of the study suggest that Curapor meets the performance requirements for a post-surgical dressing.

INTRODUCTION

Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha® Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries.

METHODS

Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta® Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690.

RESULTS

106 patients were included in the analyses. In both treatment groups, the investigator's/surgeon's general user satisfaction was rated as either "good" or "very good." The non-inferiority hypothesis that the Pro-ophta® Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12% were rated as "good" and "very good" in both treatment groups for the additional endpoints. Pro-ophta® Ocular Stick was rated better for almost all the additional endpoints and within the surgery subgroups. The mean number of sticks and surgery duration were 3.5 ± 2.74 and 11.5 (± 8.88) min, respectively, with a positive correlation (r = 0.580) for the Pro-ophta® Ocular Stick and 3.9 ± 2.45 and 9.5 (± 5.90) min, respectively, with a positive correlation (r = 0.025) for the alternative device. No device-related adverse events occurred.

CONCLUSIONS

Effective ocular sticks play an instrumental role in the outcome of ophthalmic surgeries. The investigational device demonstrated efficiency, yielding good surgical results, usability, and an exceptionally good safety profile.