Study to Evaluate DACC Dressings for the Prevention of Surgical Site Infections in Women Undergoing Caesarean Section.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomised Controlled Trial Evaluating Dialkylcarbamoyl Chloride (DACC) Impregnated Dressings for the Prevention of Surgical Site Infections in Adult Women Undergoing Caesarean Section.

Conditions
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Surgical Site Infection, Infection; Cesarean Section

Intervention / Treatment
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* Device: DACC impregnated dressing
* Device: Standard surgical dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DACC impregnated dressing<br>Patients undergoing elective or emergency caesarean section with DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively | Device: DACC impregnated dressing<br>* DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively<br>* Other names: Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden);|
| Active Comparator: Standard surgical dressing<br>Patients undergoing elective or emergency caesarean section with standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively | Device: Standard surgical dressing<br>* Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with surgical site infection | SSI determined according to Centers for Disease Control and Prevention (CDC) criteria | within the first 14 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with SSI associated wound dehiscence |  | within the first 8 weeks post surgery | 
| Length of the primary and any secondary hospitalization |  | Day 0 (day of surgery/ the first day of readmission to hospital) until the date of discharge, up to 8 weeks post surgery | 
| Readmissions to hospital due to SSI following caesarean section |  | within the first 8 weeks post surgery | 
| Percentage of patients with antibiotic treatment due to SSI following caesarean section |  | within the first 8 weeks post surgery | 
| Surgeons experience | resident, ob/gyn specialist with professional experience <5 years, ob/gyn specialist with professional experience ≥5 years | Day 0 (day of surgery) | 
| Length of surgery | minutes from skin incision until skin closure | Day 0 (day of surgery) | 
| Mode of caesarean section | elective or emergency; emergency caesarean section defined as caesarean section performed within 30 minutes from decision | Day 0 (day of surgery) | 
| Pathogens responsible for SSI | Wound swab testing to be made in all patients presenting clinical symptoms of surgical site infection | within the first 8 weeks post surgery | 
| Patients age |  | Day 0 (day of surgery) | 
| Patients race |  | Day 0 (day of surgery) | 
| Patients parity | primiparous or multiparous | Day 0 (day of surgery) | 
| Patients pre-gestational weight |  | Day 0 (day of surgery) | 
| Patients pre-gestational body mass index |  | Day 0 (day of surgery) | 
| Patients gestational weight gain |  | Day 0 (day of surgery) | 
| Percentage of patients with nicotine dependence |  | Day 0 (day of surgery) | 
| Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus |  | Day 0 (day of surgery) | 
| Patients haemoglobin concentration prior to the start of surgery |  | Day 0 (day of surgery) | 
| Patients haemoglobin concentration after the surgery |  | 24 hours after surgery | 
| Percentage of patients with surgical intervention due to SSI |  | within the first 8 weeks post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean section, surgical site infection, dialkylcarbamoylchloride impregnated dressing, wound dehiscence