CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 543 enrolled
Drug / intervention
DACC impregnated dressing +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02168023
NCT02168023N/ACompleted

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

Medical University of Warsaw·interventional·Posted Jun 19, 2014·Updated Jun 4, 2015

In Brief

A clinical study evaluating DACC impregnated dressing and Standard surgical dressing for Surgical Site Infection and Infection; Cesarean Section. Completed, enrolled 543 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 19, 2014
Enrollment StartJun 1, 2014
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.0 years ago

Interventions

DACC impregnated dressingdevice

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