Aquacel Compared to Traditional Post Surgical Wound Dress... | NCT00428623

Studies
Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients

NCT00428623

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Jan 30, 2007Estimated

Enrollment

160

Phase

Not provided

Conditions

Wound Healing
Patient Comfort

Interventions

wound dressing

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Jan 29, 2007

First Submission Date that Met QC Criteria

Jan 29, 2007

First Posted Date

Jan 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2007

Last Update Posted Date

Jan 30, 2007Estimated

Description Module

Brief Summary

The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
wound dressing	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent

Exclusion Criteria:

known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
torben V Schroeder, prof,dmsc.md	professor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Vascular Surgery, Rigshospitalet		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40260835	Derived	Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.