Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative CareOHSCWDNCT06508879
Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
A study testing Aquacel Ag Surgical® in people with Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care, run by University Medical Center Mainz at 1 site in Germany.
Trial summary
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also represent a major organizational, medical and financial challenge for the treatment team. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care
- What is being tested?
- Aquacel Ag Surgical®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Aug 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery bypass surgery
- Elective and primary surgery (no reoperations)
- Complete median sternotomy
- Age under 90 years
- Weight in the range of 50-140kg
- No known allergy to silver or other wound dressings
- No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone
- Capacity to consent
Who cannot join
- Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
- Patients own decision
- Lack of harvesting of at least one internal thoracic artery
- Peri- and post-operative ventilation for >48h
- Re-thoracotomy for reasons other than SSI, e.g., bleeding
- Mortality within the first 30 days
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiovascular Surgery, University Hospital of Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Randomized Controlled Trial: Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also represent a major organizational, medical and financial challenge for the treatment team. There is therefore still a great need for effective prevention of wound healing disorders. It goes without saying that wound management plays a major role in the development of wound healing disorders. Nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. One point of criticism is that most of the existing studies are financed by the manufacturer. Due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. After extensive literature research, we are of the opinion that the Aquacel Surgical Ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.The study is a randomized prospective clinical trial. It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee. The study should include 440 heart patients and last for 12 months. It will compare the Aquacel Surgical Ag bandage against our conventional methods. This study is being conducted independently of the industry. We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. If the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.
- Being tested
- Aquacel Ag Surgical®, Standard Care (sterile gauze and adhesive tape)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel Ag Surgical®Combination product
Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.
Standard Care (sterile gauze and adhesive tape)Other
Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | a standard wound dressing composed of sterile gauze and adhesive tape was applied under sterile conditions. In the absence of bleeding, excessive wound secretion, or detachment, the dressing was left on the wound until the second postoperative day (POD 2), otherwise, it was changed immediately. Starting at POD 2, the dressing was changed daily under aseptic conditions until the wound remained dry (between POD 3-5). In the absence of bleeding, excessive wound secretion, or detachment, the wound was then left uncovered. This practice corresponded to the standard treatment of cardiothoracic patients in our department at the time of initiating this study. Receives: Other: Standard Care (sterile gauze and adhesive tape) |
| Test Group | Experimental | directly after closing the wound, an occlusive hydrocolloid silver-containing wound dressing (Aquacel Ag Surgical®, ConvaTec, Oklahoma City, OK, USA) was applied under sterile conditions and, in the absence of bleeding; excessive wound secretion, or detachment, was maintained on the wound until POD 5, at which time the dressing was removed. In case of bleeding, excessive wound secretion, or detachment, the dressing was removed, the wound was cleaned, and a new sterile hydrocolloid wound dressing applied under aseptic conditions. Receives: Combination Product: Aquacel Ag Surgical® |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI rate
overall rate of incidence of any kind of SSI
Measured: 30 days
Secondary outcomes (3)
dressing changes
Measured: 7 days
severity of SSI
Measured: 30 days
need for treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jan 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative CareStudies of the same condition, open and under way.
- 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
- Model description
- This study was designed as a single-center randomized controlled trial. Primary endpoint was overall rate of incidence of any kind of SSI. Secondary endpoints were number of dressing changes, severity of SSI and need for treatment. Wounds were monitored daily until the 7th and on the 30th postoperative day.
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Dr. med. Kathrin Dohle, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508879
- Sponsor's protocol ID
- OHSCWD for sternotomy
- Acronym
- OHSCWD
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Does the Use of Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?
- ClinicalTrials.gov ID
- NCT06508879
- Acronym / sponsor ID
- OHSCWD / OHSCWD for sternotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 18 Jul 2024 (actual)
- 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.
Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also represent a major organizational, medical and financial challenge for the treatment team. There is therefore still a great need for effective prevention of wound healing disorders. It goes without saying that wound management plays a major role in the development of wound healing disorders. Nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. One point of criticism is that most of the existing studies are financed by the manufacturer. Due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. After extensive literature research, we are of the opinion that the Aquacel Surgical Ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.The study is a randomized prospective clinical trial. It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee. The study should include 440 heart patients and last for 12 months. It will compare the Aquacel Surgical Ag bandage against our conventional methods. This study is being conducted independently of the industry. We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. If the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a single-center randomized controlled trial. Primary endpoint was overall rate of incidence of any kind of SSI. Secondary endpoints were number of dressing changes, severity of SSI and need for treatment. Wounds were monitored daily until the 7th and on the 30th postoperative day.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Care (sterile gauze and adhesive tape)a standard wound dressing composed of sterile gauze and adhesive tape was applied under sterile conditions. In the absence of bleeding, excessive wound secretion, or detachment, the dressing was left on the wound until the second postoperative day (POD 2), otherwise, it was changed immediately. Starting at POD 2, the dressing was changed daily under aseptic conditions until the wound remained dry (between POD 3-5). In the absence of bleeding, excessive wound secretion, or detachment, the wound was then left uncovered. This practice corresponded to the standard treatment of cardiothoracic patients in our department at the time of initiating this study. |
| Test Group | Experimental | Combination Product: Aquacel Ag Surgical®directly after closing the wound, an occlusive hydrocolloid silver-containing wound dressing (Aquacel Ag Surgical®, ConvaTec, Oklahoma City, OK, USA) was applied under sterile conditions and, in the absence of bleeding; excessive wound secretion, or detachment, was maintained on the wound until POD 5, at which time the dressing was removed. In case of bleeding, excessive wound secretion, or detachment, the dressing was removed, the wound was cleaned, and a new sterile hydrocolloid wound dressing applied under aseptic conditions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Coronary artery bypass surgery
- Elective and primary surgery (no reoperations)
- Complete median sternotomy
- Age under 90 years
- Weight in the range of 50-140kg
Key exclusion criteria (6 listed)
- Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
- Patients own decision
- Lack of harvesting of at least one internal thoracic artery
- Peri- and post-operative ventilation for >48h
- Re-thoracotomy for reasons other than SSI, e.g., bleeding
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 |
|---|---|---|
| Aquacel Ag Surgical®Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms. | Combination product | Test Group |
| Standard Care (sterile gauze and adhesive tape)Presurgical preparation was identical in both groups and no further intervention in patient treatment was made. See descpription of arms. | Other | Control Group |
Primary outcome
SSI rate
Time frame: 30 days
overall rate of incidence of any kind of SSI
3 secondary outcomes
dressing changes
Time frame: 7 days
severity of SSI
Time frame: 30 days
need for treatment
Time frame: 30 days
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 18 Jul 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel Ag Surgical® in people with Surgical Site Infection; Cardiac Surgery; Advanced Dressing; Postoperative Care, run by University Medical Center Mainz at 1 site in Germany.
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 8 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 18 Jul 2024. 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 Germany. 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?
SSI rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.