Clinical trial NCT02168023: Study to Evaluate DACC Dressings for the Prevention of Surgical Site Infections in Women Undergoing Caesarean Section.
Official title: Randomised Controlled Trial Evaluating Dialkylcarbamoyl Chloride (DACC) Impregnated Dressings for the Prevention of Surgical Site Infections in Adult Women Undergoing Caesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Infection; Cesarean Section
Keywords: surgical site infection
dialkylcarbamoylchloride impregnated dressing
caesarean section
wound dehiscence
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 543
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgical site infections (SSIs) constitute an important medical and socioeconomic problem worldwide. Despite the fact that the risk factors for SSIs were identified and the continuously increasing medical knowledge in the fields of tissue engineering, molecular biology and microbiology facilitated the development of numerous new recommendations and methods for management, in many cases the available options for successful treatment of post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas, or become sites of origin for systemic infections. Patients are exposed to risk of further complications and hospitalization time extends resulting in increased total treatment costs. Treatment prolongation affects also the quality of life and psychosocial functioning of patients with impaired wound healing. Considering the arguments above, appropriate prevention and management of infected post-surgical wounds is currently one of the priorities for the majority of invasive medical disciplines.

Obstetrics constitute a field of medicine in which the issues associated with wound healing are particularly relevant. According to the literature data wound infections occur in approximately 1.8-11.3% of women undergoing caesarean section.

Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds microorganisms to the dressing fibres as a result of hydrophobic interaction. As the mechanism of DACC action is solely physical no chemical agents are released into the wound bed and the dressing could be safely used by women during puerperal period.

The purpose of this randomized controlled study is to compare the effect of DACC impregnated dressing and standard surgical dressing in the prevention of SSIs in adult women following caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors of SSIs and analyze health economics of DACC impregnated dressings for prevention of post-cesarean wound infections.

Detailed description: This is a single-blinded randomized controlled trial performed at the Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will involve 518 patients undergoing caesarean section who after giving their informed consent will be randomly divided into two groups: study (n=259) and control group (n=259). The study group will receive DACC impregnated dressing - Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) and the control group will receive standard surgical dressing.

In all participants transverse skin incision and low transverse uterine incision will be performed during caesarean section procedure.

All participants will receive prophylactic dose of antibiotics prior to the start of surgery (1g cefazolin intravenously 0-30 minutes before surgery) and wound irrigation with octenidine prior to the subcutaneous tissue closure.

For fascial incision, subcutaneous tissue and skin incision closure continuous antibacterial braided absorbable suture, single monofilament absorbable suture and subcuticular continuous monofilament non-absorbable suture will be used, respectively.

Dressing will be left in place for the first 48 hours post caesarean section unless clinical reason exists to replace it. After the first 48 hours postoperatively all of the dressings will be removed and first wound evaluation will be performed. On post-operative day 3 patients will be discharged and indicated to revisit on post-operative day 7 to remove the skin suture. During this follow-up visit second wound review will be performed for any signs of infection. Third, and final wound assessment will take place on post-operative day 14.

To analyze overall treatment costs patients with SSI will be followed up until the end of treatment, up to 8 weeks post surgery.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* undergoing elective or emergency caesarean section
* transverse skin incision
* low transverse uterine incision
* single and multiple pregnancy
* intravenous administration of 1g cefazolin 0-30 minutes prior to the start of surgery
* irrigation of the wound with octenidine prior to the subcutaneous tissue closure

Exclusion Criteria:

* patients age \<18 years
* patients physical or mental incapacity to give informed consent
* skin incision other than transverse
* uterine incision other than low transverse
* patients that did not receive routine prophylactic dose of antibiotics prior to the start of surgery
* patients without irrigation of the wound with octenidine prior to the subcutaneous tissue closure

Primary outcomes:
measure: Percentage of patients with surgical site infection
timeFrame: within the first 14 days post surgery
Secondary outcomes:
measure: Percentage of patients with SSI associated wound dehiscence
timeFrame: within the first 8 weeks post surgery
measure: Length of the primary and any secondary hospitalization
timeFrame: Day 0 (day of surgery/ the first day of readmission to hospital) until the date of discharge, up to 8 weeks post surgery
measure: Readmissions to hospital due to SSI following caesarean section
timeFrame: within the first 8 weeks post surgery
measure: Percentage of patients with antibiotic treatment due to SSI following caesarean section
timeFrame: within the first 8 weeks post surgery
measure: Surgeons experience
timeFrame: Day 0 (day of surgery)
measure: Length of surgery
timeFrame: Day 0 (day of surgery)
measure: Mode of caesarean section
timeFrame: Day 0 (day of surgery)
measure: Pathogens responsible for SSI
timeFrame: within the first 8 weeks post surgery
measure: Patients age
timeFrame: Day 0 (day of surgery)
measure: Patients race
timeFrame: Day 0 (day of surgery)
measure: Patients parity
timeFrame: Day 0 (day of surgery)
measure: Patients pre-gestational weight
timeFrame: Day 0 (day of surgery)
measure: Patients pre-gestational body mass index
timeFrame: Day 0 (day of surgery)
measure: Patients gestational weight gain
timeFrame: Day 0 (day of surgery)
measure: Percentage of patients with nicotine dependence
timeFrame: Day 0 (day of surgery)
measure: Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus
timeFrame: Day 0 (day of surgery)
measure: Patients haemoglobin concentration prior to the start of surgery
timeFrame: Day 0 (day of surgery)
measure: Patients haemoglobin concentration after the surgery
timeFrame: 24 hours after surgery
measure: Percentage of patients with surgical intervention due to SSI
timeFrame: within the first 8 weeks post surgery
Other outcomes:
measure: Cost of antibiotic treatment due to SSI
timeFrame: Day 0 (the first day of antibiotic treatment) until the last day of treatment, up to 8 weeks post surgery
measure: Cost of hospital stay due to SSI
timeFrame: Day 0 (day of SSI diagnosis/ the first day of hospital readmission due to SSI) until the end of treatment and discharge, up to 8 weeks post surgery
measure: Cost of nursing care due to SSI
timeFrame: Day 0 (day of SSI diagnosis/ the first day of hospital readmission due to SSI) until the end of treatment and discharge, up to 8 weeks post surgery
measure: Cost of surgical interventions due to SSI
timeFrame: Day 0 (day of surgery), up to 8 weeks post caesarean section
measure: Cost of ambulatory visits due to SSI
timeFrame: Day 0 (day of SSI diagnosis post-discharge) until the last ambulatory visit, up to 8 weeks post caesarean section
Locations:
city: Warsaw
country: Poland
facility: Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
state: Masovian Voivodeship
Study officials:
affiliation: Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
name: Paweł Stanirowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
name: Włodzimierz Sawicki, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Falk P, Ivarsson ML. Effect of a DACC dressing on the growth properties and proliferation rate of cultured fibroblasts. J Wound Care. 2012 Jul;21(7):327-8, 330-2. doi: 10.12968/jowc.2012.21.7.327.
citation: Ljungh A, Yanagisawa N, Wadstrom T. Using the principle of hydrophobic interaction to bind and remove wound bacteria. J Wound Care. 2006 Apr;15(4):175-80. doi: 10.12968/jowc.2006.15.4.26901. No abstract available.
citation: Gentili V, Gianesini S, Balboni PG, Menegatti E, Rotola A, Zuolo M, Caselli E, Zamboni P, Di Luca D. Panbacterial real-time PCR to evaluate bacterial burden in chronic wounds treated with Cutimed Sorbact. Eur J Clin Microbiol Infect Dis. 2012 Jul;31(7):1523-9. doi: 10.1007/s10096-011-1473-x. Epub 2011 Nov 19.
citation: Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5.
citation: Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.
citation: Butcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.