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

NCT07795489 | Completed

• 1 other identifier: SMC-GS-2026-0013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infected Wound; Diabetic Wound

Outcome Measures

Primary Outcomes (1)

• Change in wound size

  7 days after initiation of treatment

Secondary Outcomes (1)

• Treatment success rate

  Within two weeks of treatment

Other Outcomes (1)

• Duration of treatment/complete healing

  Treatment success rate within 2 weeks

Study Arms (2)

VAC Therapy

EXPERIMENTAL

Participants will receive vacuum-assisted closure (VAC) therapy for management of infected lower-limb wounds.

Device: Vacuum-Assisted Closure (VAC) Therapy

Conventional Dressing

ACTIVE COMPARATOR

Participants will receive conventional wound dressing for management of infected lower-limb wounds.

Other: Conventional dressing

Interventions

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."

VAC Therapy

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."

Conventional Dressing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \> 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).

Sponsors & Collaborators

• Sargodha Medical College: lead

Study Sites (1)

Dr Faisal Masood teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Negative-Pressure Wound Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: July 16, 2025
• Primary Completion: August 14, 2026
• Study Completion: August 24, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)