Postoperative negative-pressure incision therapy after liver transplant (PONILITRANS study): A randomized controlled trial
Postoperative complications of surgical incisions are frequent in liver transplantation. However, evidence justifying the use of incisional negative pressure wound therapy to improve surgical wound outcomes remains limited.
METHODS:Participating patients were randomly assigned to receive incisional negative pressure wound therapy or standard surgical dressing on the closed surgical incision of the liver transplantation. The primary endpoint was surgical site infection incidence 30 days postoperatively. The secondary endpoints included surgical site events (ie, surgical site infection, dehiscence, hematoma, and seroma) and wound quality of life.
RESULTS:Between December 2018 and September 2021, 108 patients (54 in the incisional negative pressure wound therapy group and 54 in the control group) were enrolled in this study. The incidence of surgical site infection at 30 days postoperatively was 7.4% in the treatment group and 13% in the control group (P = .34). The rate of surgical site events was similar in the treatment in the and control group (27.8% vs 29.6%, P = .83). In relation to wound quality of life, the mean score was 75.20 ± 7.27 in the incisional negative pressure wound therapy group and 72.82 ± 10.57 in the control group (P = .23).
CONCLUSION:The prophylactic use of negative pressure wound therapy on primarily closed incisions did not significantly reduce incisional surgical site infection and surgical site event rates after liver transplantation compared with standard surgical dressings.
CET Conclusion
| Reviewer: | Mr Keno Mentor, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | 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. |
Methodological quality
| Jadad score | 3 |
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| Allocation concealment | NO |
| Data analysis | PER PROTOCOL |
Study Details
| 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. |
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| 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 |
Metadata
| Funding: | No funding was received for this study |
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| Publication type: | Randomized Controlled Trial, Randomised Controlled Trial |
| Trial registration: | ClinicalTrials.gov - NCT04039659 |
| Organ: | Liver |
| Language: | English |
| Author email: | victor.lopez5@um.es |
| MeSH terms: | Humans; Surgical Wound; Surgical Wound Infection; Liver Transplantation; Quality of Life; Negative-Pressure Wound Therapy |