NCT05371171

Brief Summary

The complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

February 24, 2022

Last Update Submit

May 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • healing time

    three months

Study Arms (2)

skin graft

EXPERIMENTAL
Procedure: skin graft

no skin graft

PLACEBO COMPARATOR
Procedure: no skin graft

Interventions

skin graftPROCEDURE

In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing \[Alleyvn, Smith, \& Nephew\] was placed on the regrafted skin for fixation

skin graft
no skin graftPROCEDURE

In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing \[Alleyvn, Smith, \& Nephew\] was placed on the regrafted skin for fixation

no skin graft

Eligibility Criteria

Age60 Months - 99 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patient who need to perform skin grafting surgery

You may not qualify if:

  • All patient who cannot be half or general anesthetized
  • severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan Fang Hospital

Taipei County, Taiwan

Location

MeSH Terms

Interventions

Skin Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, OperativeTransplantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

May 12, 2022

Study Start

March 13, 2018

Primary Completion

May 24, 2019

Study Completion

September 3, 2019

Last Updated

May 12, 2022

Record last verified: 2022-02

Locations