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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168023
• Other study ID #: DACC-1
• Secondary ID: KB/127/2014
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: June 2, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection; Cesarean Section
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw	Warsaw	Masovian Voivodeship

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (6)

Butcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.

Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5. — View 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. — View 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. — View Citation

Ljungh A, Yanagisawa N, Wadström T. Using the principle of hydrophobic interaction to bind and remove wound bacteria. J Wound Care. 2006 Apr;15(4):175-80. — View Citation

Opøien HK, Valbø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of antibiotic treatment due to SSI	Price of antibiotics to be calculated according to manufacturer specifications.	Day 0 (the first day of antibiotic treatment) until the last day of treatment, up to 8 weeks post surgery	No
Other	Cost of hospital stay due to SSI	Cost of single hospitalization day to be obtained from hospital financial office.	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	No
Other	Cost of nursing care due to SSI	Cost of single day nursing care to be obtained from hospital financial office.	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	No
Other	Cost of surgical interventions due to SSI	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.	Day 0 (day of surgery), up to 8 weeks post caesarean section	No
Other	Cost of ambulatory visits due to SSI	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.	Day 0 (day of SSI diagnosis post-discharge) until the last ambulatory visit, up to 8 weeks post caesarean section	No
Primary	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	No
Secondary	Percentage of patients with SSI associated wound dehiscence		within the first 8 weeks post surgery	No
Secondary	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	No
Secondary	Readmissions to hospital due to SSI following caesarean section		within the first 8 weeks post surgery	No
Secondary	Percentage of patients with antibiotic treatment due to SSI following caesarean section		within the first 8 weeks post surgery	No
Secondary	Surgeons experience	resident, ob/gyn specialist with professional experience <5 years, ob/gyn specialist with professional experience =5 years	Day 0 (day of surgery)	No
Secondary	Length of surgery	minutes from skin incision until skin closure	Day 0 (day of surgery)	No
Secondary	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)	No
Secondary	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	No
Secondary	Patients age		Day 0 (day of surgery)	No
Secondary	Patients race		Day 0 (day of surgery)	No
Secondary	Patients parity	primiparous or multiparous	Day 0 (day of surgery)	No
Secondary	Patients pre-gestational weight		Day 0 (day of surgery)	No
Secondary	Patients pre-gestational body mass index		Day 0 (day of surgery)	No
Secondary	Patients gestational weight gain		Day 0 (day of surgery)	No
Secondary	Percentage of patients with nicotine dependence		Day 0 (day of surgery)	No
Secondary	Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus		Day 0 (day of surgery)	No
Secondary	Patients haemoglobin concentration prior to the start of surgery		Day 0 (day of surgery)	No
Secondary	Patients haemoglobin concentration after the surgery		24 hours after surgery	No
Secondary	Percentage of patients with surgical intervention due to SSI		within the first 8 weeks post surgery	No