Postoperative ComplicationPhase 4NCT02445300
Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in MIS TKA
A Phase 4 study testing AQUACEL® Ag Surgical dressing (study group) in people with Postoperative Complication, run by Chang Gung Memorial Hospital.
Trial summary
The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Complication
- What is being tested?
- AQUACEL® Ag Surgical dressing (study group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period.
Who cannot join
- Patients with condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, chronic skin disease around the knee (e.g. psoriasis and chronic eczema) and having prior knee replacement, osteotomy or fracture of the ipsilateral knee.
About this study
Official title: Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in Minimally Invasive Total Knee Arthroplasty：A Prospective, Randomized Controlled Study
The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).
Read the detailed description
Traditional adhesive dressing (Mepore®; Mölnlycke Health Care) for low limb arthroplasty wounds had blistering up to 26%. The jubilee dressing, which consisted of a highly absorbent Hydrofiber inner layer and (Aquacel; ConvaTec Inc.) and a viscoelastic hydrocolloid outer layer (DuoDERM Extra Thin; ConvaTec Inc.), was introduced for lower limb arthroplasty wounds with lower blistering rate (2% vs. 18%) and lower surgical site infection (1% vs. 3%) compared to traditional adhesive dressing. A new modern dressing regime (Aquacel Ag Surgical dressing; ConvaTec Inc.) also reported longer wear time, less dressing change and less blistering.
In our institution, the standard wound care after TKA was an antimicrobial dressing (Sofra-Tulle®; Royal Chem. \& Pharm. Co., Kaohsiung, Taiwan) in the inner layer and gauzes in the outer layer.
The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after MIS-TKA.
- Conditions
- Postoperative Complication
- Being tested
- AQUACEL® Ag Surgical dressing (study group), Sofra-Tulle® dressing (control group)
- Keywords
- dressing, TKA
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUACEL® Ag Surgical dressing (study group)Other
The AQUACEL® Ag Surgical dressing was applied to the wound in the operating theater by the surgeon. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer10. If there were no indications to change the dressing, it was changed at the day of discharge usually the 4th or 5th postoperative day (POD) and remained cover of the wound for 7 days except for exudate across the dressing.
Sofra-Tulle® dressing (control group)Other
The Sofra-Tulle® dressing was applied to the wound in the operating theater by the surgeon. The Sofra-Tulle® dressing was routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. After discharge from the hospital, the family who had been taught well to do this job during the patient's stay in the hospital conducted the daily dressing change.
| Study group | Role | What they receive |
|---|---|---|
| AQUACEL® Ag Surgical dressing | Active comparator | AQUACEL® Ag Surgical dressing is used to cover the surgical wound in the OR. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer. Receives: Other: AQUACEL® Ag Surgical dressing (study group) |
| Sofra-Tulla® dressing | Active comparator | The Sofra-Tulle® dressing was used in the OR and routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. Receives: Other: Sofra-Tulle® dressing (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Care Efficacy
Wear time, No. of dressing change,
Measured: an expected average of 5 days at the duration of hospital stay
Number of Participants with Adverse Events
Blister formation, wound erythema, discharge and necrosis
Measured: Three months after surgery
ASEPSIS score
Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient
Measured: 2 weeks after surgery
Surgical site infection (SSI)
Superficial or deep infection of the wound
Measured: Three months after surgery
Secondary outcomes (3)
Pain Scores on the Visual Analog Scale
overall pain management, and removal when using the dressings
Measured: two weeks after surgery
Comfort scale
The dressing is comfort in use and ease of application (excellent, good, fair or poor)
Measured: two weeks after surgery
Ease scale
The dressing is ease of application and removal (excellent, good, fair or poor)
Measured: two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Chih Kuo, Chang Gung Memorial Hospital
- Investigators
- FENG-CHIH KUO, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445300
- Sponsor's protocol ID
- CMPRG8C0711
- Status last verified
- May 2015
- First submitted
- 14 Apr 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in Minimally Invasive Total Knee Arthroplasty：A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02445300
- Acronym / sponsor ID
- CMPRG8C0711
- Conditions
- Postoperative Complication
- Keywords
- dressing, TKA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 May 2015 (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.
The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after minimally invasive total knee arthroplasty (MIS-TKA).
Detailed description
Traditional adhesive dressing (Mepore®; Mölnlycke Health Care) for low limb arthroplasty wounds had blistering up to 26%. The jubilee dressing, which consisted of a highly absorbent Hydrofiber inner layer and (Aquacel; ConvaTec Inc.) and a viscoelastic hydrocolloid outer layer (DuoDERM Extra Thin; ConvaTec Inc.), was introduced for lower limb arthroplasty wounds with lower blistering rate (2% vs. 18%) and lower surgical site infection (1% vs. 3%) compared to traditional adhesive dressing. A new modern dressing regime (Aquacel Ag Surgical dressing; ConvaTec Inc.) also reported longer wear time, less dressing change and less blistering.
In our institution, the standard wound care after TKA was an antimicrobial dressing (Sofra-Tulle®; Royal Chem. \& Pharm. Co., Kaohsiung, Taiwan) in the inner layer and gauzes in the outer layer.
The investigators hypothesized that AQUACEL® Ag Surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional Sofra-Tulle® dressings after MIS-TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQUACEL® Ag Surgical dressing | Active comparator | Other: AQUACEL® Ag Surgical dressing (study group)AQUACEL® Ag Surgical dressing is used to cover the surgical wound in the OR. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer. |
| Sofra-Tulla® dressing | Active comparator | Other: Sofra-Tulle® dressing (control group)The Sofra-Tulle® dressing was used in the OR and routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period.
Key exclusion criteria (1 listed)
- Patients with condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, chronic skin disease around the knee (e.g. psoriasis and chronic eczema) and having prior knee replacement, osteotomy or fracture of the ipsilateral knee.
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 dressing (study group)The AQUACEL® Ag Surgical dressing was applied to the wound in the operating theater by the surgeon. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer10. If there were no indications to change the dressing, it was changed at the day of discharge usually the 4th or 5th postoperative day (POD) and remained cover of the wound for 7 days except for exudate across the dressing. | Other | AQUACEL® Ag Surgical dressing |
| Sofra-Tulle® dressing (control group)The Sofra-Tulle® dressing was applied to the wound in the operating theater by the surgeon. The Sofra-Tulle® dressing was routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. After discharge from the hospital, the family who had been taught well to do this job during the patient's stay in the hospital conducted the daily dressing change. | Other | Sofra-Tulla® dressing |
Primary outcome
Wound Care Efficacy
Time frame: an expected average of 5 days at the duration of hospital stay
Wear time, No. of dressing change,
Number of Participants with Adverse Events
Time frame: Three months after surgery
Blister formation, wound erythema, discharge and necrosis
ASEPSIS score
Time frame: 2 weeks after surgery
Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria and Stay as inpatient
Surgical site infection (SSI)
Time frame: Three months after surgery
Superficial or deep infection of the wound
3 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: two weeks after surgery
Comfort scale
Time frame: two weeks after surgery
Ease scale
Time frame: two weeks after 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 15 May 2015.
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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.
FENG-CHIH KUO, MD study chair
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AQUACEL® Ag Surgical dressing (study group) in people with Postoperative Complication, run by Chang Gung Memorial Hospital.
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 1 inclusion and 1 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wound Care Efficacy (time frame: an expected average of 5 days at the duration of hospital stay). The study lists 4 primary outcomes in all. 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 15 May 2015.