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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959071
• Other study ID #: VAC vs Conventional Dressing
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: August 27, 2020

Study information

• Verified date: July 2021
• Source: Bahria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wound; Foot
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Bahria University Medical and Dental College Karachi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Bahria University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18. — View Citation

Lavery LA, Murdoch DP, Kim PJ, Fontaine JL, Thakral G, Davis KE. Negative Pressure Wound Therapy With Low Pressure and Gauze Dressings to Treat Diabetic Foot Wounds. J Diabetes Sci Technol. 2014 Mar;8(2):346-349. Epub 2014 Feb 18. — View Citation

Lone AM, Zaroo MI, Laway BA, Pala NA, Bashir SA, Rasool A. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabet Foot Ankle. 2014 Apr 8;5. doi: 10.3402/dfa.v5.23345. eCollection 2014. — View Citation

Ravari H, Modaghegh MH, Kazemzadeh GH, Johari HG, Vatanchi AM, Sangaki A, Shahrodi MV. Comparision of vacuum-asisted closure and moist wound dressing in the treatment of diabetic foot ulcers. J Cutan Aesthet Surg. 2013 Jan;6(1):17-20. doi: 10.4103/0974-2077.110091. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of mean healing time of wounds in diabetic foot ulcers among Vac and conventional dressings	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.	1 month