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Vacuum-assisted Closure Versus Conventional Dressings in Infected Lower-limb Wounds

Comparison of Vacuum-assisted Closure Versus Conventional Wound Dressings in the Management of Infected Lower-limb Wounds

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07795489
Enrollment
90
Registered
2026-08-31
Start date
2025-07-16
Completion date
2026-08-24
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected Wound, Diabetic Wound

Brief summary

Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. Delayed wound healing or non-healing of ulcers is a significant health problem, particularly in older adults. Vacuum assisted closure (VAC) is a relatively new technology with applications in a variety of difficult to manage acute and chronic wounds. Literature showed that the outcomes of VAC is a better than other method. Therefore, this study has been planned. This Randomized controlled trial will be done at Department of General Surgery, Dr Faisal Masood Teaching Hospital, Sargodha for 12 months.Sample size of 90 cases; 45 in each groups will be included through Non-probability consecutive sampling and will be randomly divided into 2 equal groups. In group A, VAC will be applied to wound. In group B, conventional dressing will be applied on wound. Wound size after one week will be assessed. If wound will heal completely, then duration for complete healing will be noted. Success will also be noted. All the data will be recorded in proforma.All the data will be analyzed with SPSS version 25. Both groups will be compared by using independent samples t-test for duration of healing, and wound size after a week and chi-square test for success. P-value ≤ 0.05 will be considered as significant. Conclusion and recommendations will be made to obtain better results with high success rate, which will lead to better quality of life and early discharge of patients.

Interventions

Application of vacuum-assisted closure (VAC) therapy to infected lower-limb wounds using negative pressure wound therapy, with appropriate wound preparation and dressing changes according to the study protocol."

Routine conventional dressing of infected lower-limb wounds using standard wound-care techniques and appropriate dressing materials, with dressing changes performed according to the study protocol."

Sponsors

Sargodha Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Adult population aged 18 - 40 years. * Gender;both male and female. * Patients having infected wound of lower limb (as per operational definition).

Exclusion criteria

* \> Recurrent cases (on medical record) * Patients with metabolic diseases, taking steroids, with peripheral vascular disease, cancer. * Patients with complications such as septic shock, diabetic ketoacidosis, or kidney injuries (on medical record) * Patients whose vitals were unstable (on clinical examination and medical record) * Patients with any evidence of underlying bone osteomyelitis and malignancy (on medical record).

Design outcomes

Primary

MeasureTime frame
Change in wound size7 days after initiation of treatment

Secondary

MeasureTime frame
Treatment success rateWithin two weeks of treatment

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026