Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients
Condition: Diabetic Foot Ulcer; Healing Delayed; Wound; Foot; Diabetes Mellitus
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional

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.
    

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.
    

Intervention name(s): Vacuum assisted closure VAC vs conventional dressing
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Conventional Dressing
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)
Primary purpose: Treatment