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Open-label randomized controlled trial evaluating dialkylcarbamoylchloride (DACC) impregnated dressings for the prevention of surgical site infection in patients undergoing abdominal surgery: the CRISTINA trial protocol
Journal article   Open access   Peer reviewed

Open-label randomized controlled trial evaluating dialkylcarbamoylchloride (DACC) impregnated dressings for the prevention of surgical site infection in patients undergoing abdominal surgery: the CRISTINA trial protocol

Kylie Sandy-Hodgetts, Khurshid Alam, Shareen Van Kempen and Paul Moroz
Chronic wound care management and research, Vol.1(1)
2026
DOI: https://doi.org/10.67702/FLES5259
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Abstract

Background: General and colorectal surgery are effective interventions for the removal and management of cancer and neoplasms. These common surgical procedures are not immune to the occurrence of postoperative complications such as surgical site infection (SSI) or surgical wound dehiscence (SWD). Published rates of SSI following abdominal surgery range from 3% to 60% in some cases, with ensuant morbidity and mortality rates. Complications such as SSI are a major cost driver to healthcare systems, often resulting in extended lengths of stay, readmission for further surgery, primary and community nursing visits, and are a costly burden to healthcare settings. Early identification of wound complications through post-discharge monitoring—using a bacteriostatic dressing, smartphone technology, and patient education—may address contributing factors and reduce the likelihood of complications occurring in the first instance. Methods: The CRISTINA trial is a phase IV powered pragmatic randomized controlled trial of 386 participants investigating the effectiveness of dialkylcarbamoylchloride (DACC)-containing dressing versus non-DACC dressing (standard of care) in the prevention of SSI in one surgical domain; abdominal surgery. A block randomization method will be used with 193 participants receiving the interventional dressing and 193 participants as control. The dressing will be applied following surgery. Participants will be provided with education prior to discharge on postoperative wound care, and how to use their smartphone to capture and send images of their wound to the study nurses. Participants will also be followed up by home care nursing services on Day 14 for suture/staples removal and wound assessment. Participants will complete a patient-reported outcomes survey on Day 14 and the EQ-5D-5L for quality-of-life assessment. All participants are closed out of the study Day 30. Discussion: The results of this trial may support the development of a novel clinical pathway combining bacteriostatic dressings and remote digital surgical wound monitoring to prevent acute hospital readmissions due to wound complications, through early detection and rapid intervention.

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