Postoperative negative-pressure incision therapy after liver transplant (PONILITRANS study): A randomized controlled trial.
Lopez-Lopez, V., et al.Surgery 2022 [record in progress].
Aims
This study aimed to compare the prophylactic use of incisional negative pressure wound therapy (iNPWT) versus the traditional use of dressings in patients undergoing liver transplantation.
Interventions
Participants were randomised to receive either iNPWT or standard surgical dressing on the closed surgical incision after liver transplant.
Participants
120 patients undergoing elective liver transplantation.
Outcomes
The primary outcome was the incidence of surgical site infection 30 days postoperation. The secondary endpoints were surgical site events (such as surgical site infection, hematoma, dehiscence and seroma) and wound-related quality of life.
Follow-up
30 days
CET Conclusions
This unblinded RCT investigates the efficacy of prophylactic negative pressure incision therapy (iNPWT) in patients undergoing liver transplantation. iNPWT has been extensively studied in various surgical patient groups, where a benefit has been demonstrated but debate still exists about specific indications. This study found no significant difference in the primary outcome of surgical site infections (SSI) between the two groups. The two groups were generally homogenous but there was a higher rate of corticosteroid use in the treatment group. This could have masked a potential benefit of iNPWT but it also highlights that patient and treatment factors are stronger determinants of the risk of SSI than the wound dressing used. Further study is unlikely to contribute more to this question and should only be directed to certain high-risk patient sub-groups.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT04039659