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Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL® Ag Surgical Dressing in MIS TKA

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ClinicalTrials.gov Identifier: NCT02445300
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Feng Chih Kuo, Chang Gung Memorial Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Postoperative Complication Other: AQUACEL® Ag Surgical dressing (study group) Other: Sofra-Tulle® dressing (control group) Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

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Arm Intervention/treatment
Active Comparator: AQUACEL® Ag Surgical dressing
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.
Other: 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.

Active Comparator: Sofra-Tulla® dressing
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.
Other: 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.




Primary Outcome Measures :
  1. Wound Care Efficacy [ Time Frame: an expected average of 5 days at the duration of hospital stay ]
    Wear time, No. of dressing change,

  2. Number of Participants with Adverse Events [ Time Frame: Three months after surgery ]
    Blister formation, wound erythema, discharge and necrosis

  3. 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

  4. Surgical site infection (SSI) [ Time Frame: Three months after surgery ]
    Superficial or deep infection of the wound


Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: two weeks after surgery ]
    overall pain management, and removal when using the dressings

  2. Comfort scale [ Time Frame: two weeks after surgery ]
    The dressing is comfort in use and ease of application (excellent, good, fair or poor)

  3. Ease scale [ Time Frame: two weeks after surgery ]
    The dressing is ease of application and removal (excellent, good, fair or poor)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two hundred and eighty five patients who were scheduled for primary unilateral MIS-TKA were enrolled in the study period.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445300


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: FENG-CHIH KUO, MD Chang Gung Memorial Hospital

Responsible Party: Feng Chih Kuo, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02445300     History of Changes
Other Study ID Numbers: CMPRG8C0711
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015

Keywords provided by Feng Chih Kuo, Chang Gung Memorial Hospital:
dressing
TKA

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents