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

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ClinicalTrials.gov Identifier: NCT02168023
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Paweł Stanirowski, Medical University of Warsaw

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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Infection; Cesarean Section Device: DACC impregnated dressing Device: Standard surgical dressing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: DACC impregnated dressing
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
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 Name: Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168023


Locations
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Poland
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 03-242
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Paweł Stanirowski, MD Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Study Director: Włodzimierz Sawicki, MD, PhD Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Publications:
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Responsible Party: Paweł Stanirowski, Doctor of Medicine, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02168023    
Other Study ID Numbers: DACC-1
KB/127/2014 ( Other Identifier: Ethics Committee approval number )
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Paweł Stanirowski, Medical University of Warsaw:
surgical site infection
dialkylcarbamoylchloride impregnated dressing
caesarean section
wound dehiscence
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes