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Compare dry and wet collagen sheet on superficial raw areas

A Randomized Control Trial Comparing Wet and Dry Collagen Sheets for Healing Skin Graft Donor Sites in Adult Patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100818
Enrollment
132
Registered
2026-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: Wet Collagen Sheet: Collagen scaffold in hydrated form available in various sizes to be applied over the graft donor sites Duration will be one time. Control Intervention1: Dry Collage

Sponsors

ED and CEO
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing split-thickness skin grafting for burns sequelae and trauma. Maximum donor site size or skin requirement: 15 cm x 20 cm. Patients providing informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: oKnown allergy or hypersensitivity to collagen-based products. o Donor site size exceeding or skin requirement more than15 cm x 20 cm. o Patient with Serum Album levels less than 3 gm/dl and Hb less than 10gm /dl o Presence of systemic conditions affecting wound healing, such as uncontrolled diabetes or peripheral vascular disease. o Use of immunosuppressive medications within six months prior to enrollment. o Poorly controlled or active infections at the donor site.

Design outcomes

Secondary

MeasureTime frame
Pain Scores: Measured using the Visual Analog Scale (VAS) at days 1, 3, 7, & 14 post-operativelyTimepoint: Day 1,3,7 & 14;Complications: Incidence of infection (ASEPSIS scoring), hypertrophic scarring (Vancouver Scar Scale), & delayed healing.Timepoint: Days 1, 3, 7, 14; , Months 1, 4, 6, 8

Primary

MeasureTime frame
Healing Time, Time (in days) to achieve more than 95 percent epithelialization, assessed by digital planimetry and clinical evaluation.Timepoint: Baseline, Pre Surgery, Day 1,3,7, 14, and Months 1,4,6,8.

Countries

India

Contacts

Public ContactDr Al Iqyan Fidvi

AIIMS, NAgpur

aliqyan@aiimsnagpur.edu.in9623224466

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026