ASOLO-SCI01
Research type
Research Study
Full title
A prospective, open, non-comparative, post-market clinical follow-up investigation to confirm the safety and performance of Avance® Solo NPWT System in surgically closed incisions
IRAS ID
295343
Contact name
Alexandre Welikow
Contact email
Sponsor organisation
Molnlycke Health Care AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
Summary of Research
The ASOLO-SCI study is performed to confirm the safety and performance of a medical device system (Mölnlycke's Avance® Solo NPWT System) in closed surgical cuts (incisions) with low to moderate wound drainage (exudate). This system is made of parts that are compliant to the European Economic Area standards of health, safety and environmental protection (CE marked), which allow it to be marketed in the European Economic Area. The Avance® Solo NPWT System is a Single Use Negative Pressure Wound Therapy (suNPWT) system. It applies through a pump, connectors, and a sealed dressing, suction over a wound to support wound healing through the removal of wound drainage and infectious material. To enable safe and effective usage of medical devices, these need to be tested in their clinical setting as part of their CE mark maintenance. Mölnlycke is sponsoring this Post-Market Follow-up Study to obtain clinical data that the system works in maintaining the surgical cut closed, when used in accordance to its Instructions for Use. The system will be used on patients that fulfill all of the inclusion, and none of the exclusion criteria. Are eligible to participate up to 34, men or non-pregnant/breastfeeding women, aged 18 or older, with closed surgical cuts and low to moderate wound drainage. Patients participate in the study through approximately 1 United Kingdom and 2 Belgium health care centres. Potential participants will be screened for eligibility and invited to confirm their voluntary participation through signing of a Consent Form. Participants initiate the study treatment with Avance® Solo NPWT System at a Baseline Visit, and are followed for up to 14 days with at least 2 visits at Days 7 and 14 for wound/system management. The study follow-up may terminate earlier should participants withdraw their consent, or the research doctor/delegated research staff decide so.
Summary of Results
THANK YOU TO STUDY PARTICIPANTS The ASOLO-SCI study clinical team at Guy's and St Thomas' NHS Foundation Trust, and the Sponsor, Mölnlycke Health Care, wish to thank all of the study patients for their participation in this important study to confirm the safety and performance of the Avance Solo NPWT System in the treatment of closed surgical cuts with low to moderate drainage.
The study took place in the United Kingdom in one centre, at Guy's and St Thomas' NHS Foundation Trust, and two clinics in Belgium during the first half of 2022. Mölnlycke Health Care sponsored this study to obtain clinical data that the system worked in maintaining the surgical cut closed, when used in accordance to its Instructions for Use.SUMMARY OF RESULTS
In total, 35 participants with closed surgical cuts (incisions) were treated with the Avance Solo NPWT System in this clinical investigation. All cuts remained closed throughout the clinical investigation.
Wound progress was achieved in a majority of the participants, both when compared to baseline and compared to a previous visit. All participants except one experienced full opposition of the cut's borders at final visit.
Exudate amounts, types and odour were in line with the wound progress variable, with improvements throughout. Close to all participants experienced normal peri-wound skin.
Participants experienced low levels of pain between and at dressing changes, and there was no or very little trauma to the wound and surrounding skin at dressing changes.
Overall, the system was well perceived by the clinicians (investigators) and participants, as the system was found to be easy to use and with a high level of global satisfaction; and there were few reports of negative effects on participants' everyday life.
Safety data for 35 subjects consisted of a total of 13 Adverse Events (AEs) reported in relation to 12 subjects. Out of the 13 AEs reported, three were Serious AEs. Five out of 13 AEs were judged to be Adverse Device Effects (ADEs). No ADE was rated as serious.
A total of 16 Device Deficiencies (DDs) were reported in 12 participants, a majority of the DDs were dressing-related to leakage.CONCLUSION
In conclusion, all cuts remained closed in the investigation and wound progress was seen throughout. The data collected in this investigation confirm the safety and performance of the Avance Solo NPWT System in low to moderate exuding closed surgical incisions when used in accordance with the Instructions for Use, for up to 14 days.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0153
Date of REC Opinion
2 Aug 2021
REC opinion
Further Information Favourable Opinion