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NCT Number: NCT02168023

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

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.

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Key information

Conditions

Surgical Site Infection Infection; Cesarean Section Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-242, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DACC impregnated dressing

Device

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

Other names: Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)

Standard surgical dressing

Device

Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively

Primary outcomes

  1. Percentage of patients with surgical site infection

    Time frame: within the first 14 days post surgery

    SSI determined according to Centers for Disease Control and Prevention (CDC) criteria

Secondary outcomes

  1. Percentage of patients with SSI associated wound dehiscence

    Time frame: within the first 8 weeks post surgery

  2. Length of the primary and any secondary hospitalization

    Time frame: Day 0 (day of surgery/ the first day of readmission to hospital) until the date of discharge, up to 8 weeks post surgery

  3. Readmissions to hospital due to SSI following caesarean section

    Time frame: within the first 8 weeks post surgery

  4. Percentage of patients with antibiotic treatment due to SSI following caesarean section

    Time frame: within the first 8 weeks post surgery

  5. Surgeons experience

    Time frame: Day 0 (day of surgery)

    resident, ob/gyn specialist with professional experience <5 years, ob/gyn specialist with professional experience ≥5 years

  6. Length of surgery

    Time frame: Day 0 (day of surgery)

    minutes from skin incision until skin closure

  7. Mode of caesarean section

    Time frame: Day 0 (day of surgery)

    elective or emergency; emergency caesarean section defined as caesarean section performed within 30 minutes from decision

  8. Pathogens responsible for SSI

    Time frame: within the first 8 weeks post surgery

    Wound swab testing to be made in all patients presenting clinical symptoms of surgical site infection

  9. Patients age

    Time frame: Day 0 (day of surgery)

  10. Patients race

    Time frame: Day 0 (day of surgery)

  11. Patients parity

    Time frame: Day 0 (day of surgery)

    primiparous or multiparous

  12. Patients pre-gestational weight

    Time frame: Day 0 (day of surgery)

  13. Patients pre-gestational body mass index

    Time frame: Day 0 (day of surgery)

  14. Patients gestational weight gain

    Time frame: Day 0 (day of surgery)

  15. Percentage of patients with nicotine dependence

    Time frame: Day 0 (day of surgery)

  16. Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus

    Time frame: Day 0 (day of surgery)

  17. Patients haemoglobin concentration prior to the start of surgery

    Time frame: Day 0 (day of surgery)

  18. Patients haemoglobin concentration after the surgery

    Time frame: 24 hours after surgery

  19. Percentage of patients with surgical intervention due to SSI

    Time frame: within the first 8 weeks post surgery

Other outcomes

  1. Cost of antibiotic treatment due to SSI

    Time frame: Day 0 (the first day of antibiotic treatment) until the last day of treatment, up to 8 weeks post surgery

    Price of antibiotics to be calculated according to manufacturer specifications.

  2. Cost of hospital stay due to SSI

    Time frame: 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

    Cost of single hospitalization day to be obtained from hospital financial office.

  3. Cost of nursing care due to SSI

    Time frame: 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

    Cost of single day nursing care to be obtained from hospital financial office.

  4. Cost of surgical interventions due to SSI

    Time frame: Day 0 (day of surgery), up to 8 weeks post caesarean section

    Cost of surgical intervention to be approximated using Polish National Health Fund specifications for Diagnosis Related Groups and International Classification of Diseases version 10 (ICD-10) codes.

  5. Cost of ambulatory visits due to SSI

    Time frame: Day 0 (day of SSI diagnosis post-discharge) until the last ambulatory visit, up to 8 weeks post caesarean section

    Cost of ambulatory visit to be approximated using Polish National Health Fund specifications for Diagnosis Related Groups and International Classification of Diseases version 10 (ICD-10) codes.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2014
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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