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Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients

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ClinicalTrials.gov Identifier: NCT04959071
Recruitment Status : Completed
First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Mehwish Mooghal , MBBS, Bahria University

Brief Summary:

Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients.

DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Amongst them VAC provides a new paradigm for diabetic wound dressing. Different studies concluded that DFUs treated with VAC are more likely to heal than CD.

The average healing time varies greatly among different studies conducted. Therefore, we conducted this study to compare the mean healing time of wound after VAC and CD in DFU patients. Based on these results, the method with lesser healing time can be opted for our routine practice guidelines for DFU patient's management protocol.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Healing Delayed Wound; Foot Diabetes Mellitus Procedure: Vacuum assisted closure VAC vs conventional dressing Not Applicable

Detailed Description:

This Randomized controlled trial was conducted at Department of General Surgery, at a tertiary teaching hospital , over duration of six months from 28th February 2020 to 27th August 2020. The calculated sample size was 60 i.e. 30 cases in each group, with 5% level of significance, 80% power of study and taking mean healing time with VAC therapy as 11.366 ± 3.488 days and with conventional dressing as 16.41 ± 3.104 days.6 Non-probability, consecutive sampling technique was used.

After taking permission from ethical review committee , total 60 patients who were presented in outpatient Department of Surgery, at a tertiary care Hospital, Karachi, fulfilling the inclusion criteria was selected. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. In patients undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours. In patients with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups as described in operational definition. This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial. After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group. In group A patients, VAC dressing was applied while in group B conventional dressing was applied. All patients were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . This all data (age, gender, duration of ulcer, and size of ulcer, BMI, and healing time) was recorded on a specially designed Performa designed beforehand.
Masking: Single (Participant)
Masking Description: After informed, written consent, all selected cases were offered to pick up a slip from total mixed up slips (half-slips contained letter 'A' and other half slips contained letter 'B') and he/she was placed in that respective group.
Primary Purpose: Treatment
Official Title: Comparison of the Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
Actual Study Start Date : February 28, 2020
Actual Primary Completion Date : August 27, 2020
Actual Study Completion Date : August 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Group A included participants who underwent VAC therapy for diabetic Foot ulcers
Procedure: Vacuum assisted closure VAC vs conventional dressing

In participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours.

In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily.

Other Name: Conventional Dressing

Active Comparator: Group B
Group B included participants who underwent conventional dressings for diabetic foot ulcers
Procedure: Vacuum assisted closure VAC vs conventional dressing

In participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours.

In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily.

Other Name: Conventional Dressing




Primary Outcome Measures :
  1. Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings [ Time Frame: 1 month ]
    participants were assessed for mean healing time of wound after VAC theray and conventional dressing. All participants were followed regularly by the single researcher and mean healing time was noted in every patient of both groups . Healing time was measured in number of days. The start time was the application of first VAC and end time will be the day of wound healing (appearance of granulation tissue over wound as assessed clinically). Similarly start time in conventional dressings was from day of first application of conventional dressing till appearance of granulation tissues over the wound. In both groups mean healing time was compared to see any difference in healing time of both the groups.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. All patients with diabetic foot ulcer of >2 weeks duration. 2. Size of ulcer >3 cm. 3. Well controlled diabetes (HbA1C=6-8.3%). 4. Age 25-65 years. 5. Both genders.

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Exclusion Criteria:

  1. Anemic patients (hemoglobin <10 g/dl).
  2. Patients with history of steroid intake.
  3. Patients with chronic renal failure (assessed on history and s/creatinine >1.5 mg/dl).
  4. Patients with history of immunosuppressive therapy.
  5. Ulcers involving bone as well.

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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): NCT04959071


Locations
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Pakistan
Bahria University Medical and Dental College Karachi
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Bahria University
Publications:
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Responsible Party: Mehwish Mooghal , MBBS, Resident Surgery at PNS Shifa Hospital Karachi, Bahria University
ClinicalTrials.gov Identifier: NCT04959071    
Other Study ID Numbers: VAC vs Conventional Dressing
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases