Application of PREVENA (Surgical Incision Protection System) in reducing surgical site infections following reversal
Ernest Z Low1, Timothy S Nugent2, Niall J O'Sullivan3
1Department of Colorectal Surgery, St James's Hospital, Trinity College Dublin, Dublin, Ireland. lowe@tcd.ie.
Insights
This study investigates if negative pressure wound therapy (NPWT) reduces surgical site infections (SSI) after ostomy reversal compared to standard dressings. Results will determine if NPWT becomes the new standard of care for these procedures.
Area of Science:
- Surgical oncology
- Wound healing research
- Infection control
Background:
- Surgical site infections (SSI) are a complication after ileostomy or colostomy reversal.
- Evidence is lacking on the efficacy of negative pressure wound therapy (NPWT) in preventing SSI in these specific cases.
- Conventional dressings are the current standard, but their effectiveness in reducing SSI risk is not fully established.
Purpose of the Study:
- To compare the incidence of SSI between routine NPWT and conventional dressings after stoma reversal.
- To evaluate if NPWT is superior to conventional dressings in reducing SSI rates.
- To determine if NPWT should be considered the new standard of care for wound management post-ostomy reversal.
Main Methods:
- A randomized, controlled, open-label, multi-centre superiority trial (PRIC study).
- Participants randomized 1:1 to receive either NPWT (PREVENA) or conventional dressings immediately post-surgery.
- Wound assessment at post-operative day seven and follow-up appointments; primary endpoint is SSI incidence within 30 days.
Main Results:
- Data collection is ongoing, and results are pending.
- The study aims to provide definitive data on SSI rates and wound healing outcomes.
- Secondary endpoints include time to wound healing, wound aesthetics, and patient satisfaction.
Conclusions:
- The PRIC study will determine if routine NPWT reduces SSI rates compared to conventional dressings.
- Findings will inform clinical practice regarding the optimal wound management strategy after ileostomy or colostomy reversal.
- The study seeks to establish a new standard of care for wound closure in these procedures.
Aim:
There is a current lack of evidence in the literature to support the routine use of negative pressure wound therapy (NPWT) to reduce the risk of surgical site infections (SSI) in the setting of ileostomy or colostomy reversal. The aim of this study is to examine whether routine NPWT confers a lower rate of SSI than conventional dressings following reversal of ileostomy or colostomy.
Methods:
The PRIC study is a randomized, controlled, open-label, multi-centre superiority trial to assess whether routine NPWT following wound closure confers a lower rate of SSI following reversal of ileostomy or colostomy when compared to conventional dressings. Participants will be consecutively identified and recruited. Eligible participants will be randomized in a 1:1 allocation ratio, to receive either the NPWT (PREVENA) dressings or conventional dressings which will be applied immediately upon completion of surgery. PREVENA dressings will remain applied for a duration of 7 days. Surgical wounds will then be examined on post-operative day seven as well as during follow-up appointments in OPD for any evidence of SSI. In the interim, public health nurses (PHN) will provide out-patient support services incorporating wound assessment and care as part of a routine basis. Study investigators will liaise with PHN to gather the relevant data in relation to the time to wound healing. Our primary endpoint is the incidence of SSI within 30 days of stoma reversal. Secondary endpoints include measuring time to wound healing, evaluating wound healing and aesthetics and assessing patient satisfaction.
Conclusion:
The PRIC study will assess whether routine NPWT following wound closure is superior to conventional dressings in the reduction of SSI following reversal of ileostomy or colostomy and ascertain whether routine NPWT should be considered the new standard of care.
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