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Completed

NCT Number: NCT07795489

"VAC Versus Conventional Dressings for Infected Lower-Limb Wounds"

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Faisal Masood teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vacuum-Assisted Closure (VAC) Therapy

Device

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."

Conventional Dressing

Other

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."

Primary outcomes

  1. Wound size reduction

    Time frame: 7 days after initiation of treatment

    Wound size reduction Time frame: 7 days after initiation of treatment. Measure: Reduction in wound size, measured in cm².

  2. Wound size reduction

    Time frame: 7 days after initiation of treatment.

    . Measure: Reduction in wound size, measured in cm².

Secondary outcomes

  1. Treatment success rate

    Time frame: Within two weeks of treatment

    Treatment success rate Time frame: Within 2 weeks of treatment. Measure: Proportion of patients achieving complete healing without requiring amputation or further surgery. Dr. Asma synopsis Final.doc

Other outcomes

  1. Duration of treatment/complete healing

    Time frame: * Wound size reduction after 7 days * Treatment success rate within 2 weeks

    Duration of treatment/complete healing

    • Wound size reduction after 7 days
    • Treatment success rate within 2 weeks

Sponsors and collaborators

Lead sponsor

Sargodha Medical College

Other

Registry information

Official study title

COMPARISON OF VACUUM ASSISTED CLOSURE VERSUS CONVENTIONAL WOUND DRESSINGS OF INFECTED WOUNDS OF LOWER LIMB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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