Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap

Trauma Clinical Trial

Official title:

Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486719
• Other study ID #: CHEN-19750306
• Status: Completed
• Phase: N/A
• First received: December 4, 2011
• Last updated: December 5, 2011
• Start date: February 2008
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Description:

From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients. The flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm. The mean pedicle length was 1.2 cm. Neurorrhaphy between the dorsal branches of the PDN and PDN was performed in both sides in all cases. Sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test. The range of motion of the donor fingers was measured. The data were compared to those of the opposite sides.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. a finger pulp defect > 1.5 cm in length

2. necessity to preserve finger length

3. patients younger than 60 years .

Exclusion Criteria:

1. injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site

2. injury to the course of the vascular pedicle or opposite PDA

3. defects < 1.5 cm in length.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma

Intervention

Procedure:
• Sensate Dorsal Digital Island Flap
This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan	Chinese PLA General Hospital, The Second Hospital of Qinhuangdao

References & Publications (2)

Bene MD, Petrolati M, Raimondi P, Tremolada C, Muset A. Reverse dorsal digital island flap. Plast Reconstr Surg. 1994 Mar;93(3):552-7. — View Citation

Pelissier P, Casoli V, Bakhach J, Martin D, Baudet J. Reverse dorsal digital and metacarpal flaps: a review of 27 cases. Plast Reconstr Surg. 1999 Jan;103(1):159-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	static 2-point discrimination test	The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site. According to the Michigan Hand Outcomes Questionnaire (MHQ), patients reported their satisfaction with the appearance of the injured hand. The questions based on a 5-point response scale.	Patients were followed for 16-23 months (mean, 19 months)	No
Secondary	Semmes-Weinstein monofilament test	The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site.	Patients were followed for 16-23 months (mean, 19 months)	No