Surgical Site InfectionNCT02168023
Study to Evaluate DACC Dressings for the Prevention of Surgical Site Infections in Women Undergoing Caesarean Section.
A study testing DACC impregnated dressing and Standard surgical dressing in people with Surgical Site Infection and Infection; Cesarean Section, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection, Infection; Cesarean Section
- What is being tested?
- DACC impregnated dressing and Standard surgical dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 03-242
About this study
Official title: Randomised Controlled Trial Evaluating Dialkylcarbamoyl Chloride (DACC) Impregnated Dressings for the Prevention of Surgical Site Infections in Adult 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.
Read more
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.
Read the 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.
- Being tested
- DACC impregnated dressing, Standard surgical dressing
- Keywords
- surgical site infection, dialkylcarbamoylchloride impregnated dressing, caesarean section, wound dehiscence
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DACC impregnated dressingDevice
Also called Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)
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
Standard surgical dressingDevice
Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| DACC impregnated dressing | Experimental | 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 Receives: Device: DACC impregnated dressing |
| Standard surgical dressing | Active comparator | 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 Receives: Device: Standard surgical dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with surgical site infection
SSI determined according to Centers for Disease Control and Prevention (CDC) criteria
Measured: within the first 14 days post surgery
Secondary outcomes (19)
Percentage of patients with SSI associated wound dehiscence
Measured: within the first 8 weeks post surgery
Length of the primary and any secondary hospitalization
Measured: 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
Measured: within the first 8 weeks post surgery
Percentage of patients with antibiotic treatment due to SSI following caesarean section
Measured: 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
Measured: Day 0 (day of surgery)
Length of surgery
minutes from skin incision until skin closure
Measured: 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
Measured: 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
Measured: within the first 8 weeks post surgery
Patients age
Measured: Day 0 (day of surgery)
Patients race
Measured: Day 0 (day of surgery)
Patients parity
primiparous or multiparous
Measured: Day 0 (day of surgery)
Patients pre-gestational weight
Measured: Day 0 (day of surgery)
Patients pre-gestational body mass index
Measured: Day 0 (day of surgery)
Patients gestational weight gain
Measured: Day 0 (day of surgery)
Percentage of patients with nicotine dependence
Measured: Day 0 (day of surgery)
Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus
Measured: Day 0 (day of surgery)
Patients haemoglobin concentration prior to the start of surgery
Measured: Day 0 (day of surgery)
Patients haemoglobin concentration after the surgery
Measured: 24 hours after surgery
Percentage of patients with surgical intervention due to SSI
Measured: within the first 8 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paweł Stanirowski, Medical University of Warsaw
- Investigators
- Paweł Stanirowski, MD, Principal investigator, Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of WarsawWłodzimierz Sawicki, MD, PhD, Study director, Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168023
- Sponsor's protocol ID
- DACC-1
- Other IDs
- KB/127/2014
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22886332Ljungh 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.
PubMed 16620048Gentili 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.
PubMed 22113306Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5.
PubMed 20852534Opoien 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.
PubMed 17712651Butcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Evaluating Dialkylcarbamoyl Chloride (DACC) Impregnated Dressings for the Prevention of Surgical Site Infections in Adult Women Undergoing Caesarean Section.
- ClinicalTrials.gov ID
- NCT02168023
- Acronym / sponsor ID
- DACC-1
- Keywords
- surgical site infection, dialkylcarbamoylchloride impregnated dressing, caesarean section, wound dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DACC impregnated dressing | Experimental | Device: DACC impregnated dressingPatients 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 |
| Standard surgical dressing | Active comparator | Device: Standard surgical dressingPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 18 years
- undergoing elective or emergency caesarean section
- transverse skin incision
- low transverse uterine incision
- single and multiple pregnancy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DACC impregnated dressingAlso: Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)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 |
| Standard surgical dressingStandard 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 |
Primary outcome
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
19 secondary outcomes
Percentage of patients with SSI associated wound dehiscence
Time frame: within the first 8 weeks post surgery
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
Readmissions to hospital due to SSI following caesarean section
Time frame: within the first 8 weeks post surgery
Percentage of patients with antibiotic treatment due to SSI following caesarean section
Time frame: within the first 8 weeks post surgery
Surgeons experience
Time frame: Day 0 (day of surgery)
Length of surgery
Time frame: Day 0 (day of surgery)
Mode of caesarean section
Time frame: Day 0 (day of surgery)
Pathogens responsible for SSI
Time frame: within the first 8 weeks post surgery
Patients age
Time frame: Day 0 (day of surgery)
Patients race
Time frame: Day 0 (day of surgery)
Patients parity
Time frame: Day 0 (day of surgery)
Patients pre-gestational weight
Time frame: Day 0 (day of surgery)
Patients pre-gestational body mass index
Time frame: Day 0 (day of surgery)
Patients gestational weight gain
Time frame: Day 0 (day of surgery)
Percentage of patients with nicotine dependence
Time frame: Day 0 (day of surgery)
Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus
Time frame: Day 0 (day of surgery)
Patients haemoglobin concentration prior to the start of surgery
Time frame: Day 0 (day of surgery)
Patients haemoglobin concentration after the surgery
Time frame: 24 hours after surgery
Percentage of patients with surgical intervention due to SSI
Time frame: within the first 8 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 22886332Falk 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.
- Background: PubMed 16620048Ljungh 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.
- Background: PubMed 22113306Gentili 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.
- Background: PubMed 20852534Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5.
- Background: PubMed 17712651Opoien 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.
- BackgroundButcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Stanirowski, MD principal investigator
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
Włodzimierz Sawicki, MD, PhD study director
Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DACC impregnated dressing and Standard surgical dressing in people with Surgical Site Infection and Infection; Cesarean Section, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with surgical site infection (time frame: within the first 14 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168023, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.