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

Primary Purpose

Surgical Site Infection, Infection; Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
DACC impregnated dressing
Standard surgical dressing
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring surgical site infection, dialkylcarbamoylchloride impregnated dressing, caesarean section, wound dehiscence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DACC impregnated dressing

Standard surgical dressing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of patients with surgical site infection
SSI determined according to Centers for Disease Control and Prevention (CDC) criteria

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2014
Last Updated
June 2, 2015
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02168023
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Infection; Cesarean Section
Keywords
surgical site infection, dialkylcarbamoylchloride impregnated dressing, caesarean section, wound dehiscence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DACC impregnated dressing
Arm Type
Experimental
Arm Description
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
Arm Title
Standard surgical dressing
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
DACC impregnated dressing
Other Intervention Name(s)
Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard surgical dressing
Intervention Description
Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
Primary Outcome Measure Information:
Title
Percentage of patients with surgical site infection
Description
SSI determined according to Centers for Disease Control and Prevention (CDC) criteria
Time Frame
within the first 14 days post surgery
Secondary Outcome Measure Information:
Title
Percentage of patients with SSI associated wound dehiscence
Time Frame
within the first 8 weeks post surgery
Title
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
Title
Readmissions to hospital due to SSI following caesarean section
Time Frame
within the first 8 weeks post surgery
Title
Percentage of patients with antibiotic treatment due to SSI following caesarean section
Time Frame
within the first 8 weeks post surgery
Title
Surgeons experience
Description
resident, ob/gyn specialist with professional experience <5 years, ob/gyn specialist with professional experience ≥5 years
Time Frame
Day 0 (day of surgery)
Title
Length of surgery
Description
minutes from skin incision until skin closure
Time Frame
Day 0 (day of surgery)
Title
Mode of caesarean section
Description
elective or emergency; emergency caesarean section defined as caesarean section performed within 30 minutes from decision
Time Frame
Day 0 (day of surgery)
Title
Pathogens responsible for SSI
Description
Wound swab testing to be made in all patients presenting clinical symptoms of surgical site infection
Time Frame
within the first 8 weeks post surgery
Title
Patients age
Time Frame
Day 0 (day of surgery)
Title
Patients race
Time Frame
Day 0 (day of surgery)
Title
Patients parity
Description
primiparous or multiparous
Time Frame
Day 0 (day of surgery)
Title
Patients pre-gestational weight
Time Frame
Day 0 (day of surgery)
Title
Patients pre-gestational body mass index
Time Frame
Day 0 (day of surgery)
Title
Patients gestational weight gain
Time Frame
Day 0 (day of surgery)
Title
Percentage of patients with nicotine dependence
Time Frame
Day 0 (day of surgery)
Title
Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus
Time Frame
Day 0 (day of surgery)
Title
Patients haemoglobin concentration prior to the start of surgery
Time Frame
Day 0 (day of surgery)
Title
Patients haemoglobin concentration after the surgery
Time Frame
24 hours after surgery
Title
Percentage of patients with surgical intervention due to SSI
Time Frame
within the first 8 weeks post surgery
Other Pre-specified Outcome Measures:
Title
Cost of antibiotic treatment due to SSI
Description
Price of antibiotics to be calculated according to manufacturer specifications.
Time Frame
Day 0 (the first day of antibiotic treatment) until the last day of treatment, up to 8 weeks post surgery
Title
Cost of hospital stay due to SSI
Description
Cost of single hospitalization day to be obtained from hospital financial office.
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
Title
Cost of nursing care due to SSI
Description
Cost of single day nursing care to be obtained from hospital financial office.
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
Title
Cost of surgical interventions due to SSI
Description
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.
Time Frame
Day 0 (day of surgery), up to 8 weeks post caesarean section
Title
Cost of ambulatory visits due to SSI
Description
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.
Time Frame
Day 0 (day of SSI diagnosis post-discharge) until the last ambulatory visit, up to 8 weeks post caesarean section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Stanirowski, MD
Organizational Affiliation
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Włodzimierz Sawicki, MD, PhD
Organizational Affiliation
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Official's Role
Study Director
Facility Information:
Facility Name
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
City
Warsaw
State/Province
Masovian Voivodeship
ZIP/Postal Code
03-242
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22886332
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.
Results Reference
background
PubMed Identifier
16620048
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.
Results Reference
background
PubMed Identifier
22113306
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.
Results Reference
background
PubMed Identifier
20852534
Citation
Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5.
Results Reference
background
PubMed Identifier
17712651
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.
Results Reference
background
Citation
Butcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.
Results Reference
background

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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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